Compositions and methods for regulating mammalian keratinous tissue (2025)

U.S. patent number 7,285,570 [Application Number 10/418,594] was granted by the patent office on 2007-10-23 for compositions and methods for regulating mammalian keratinous tissue. This patent grant is currently assigned to The Procter & Gamble Company. Invention is credited to Larry Richard Robinson, Paul Robert Tanner.

Compositions and methods for regulating mammalian keratinoustissue

Abstract

Skin care compositions and methods for regulating the conditionof mammalian keratinous tissue containg an effective amount of adialkanoyl hydroxyproline compound and a second skin care compoundselected from hexamidine compounds, sugar amine compounds and theircombination. These compositions may be either an emulsion or asolution wherin the dialkanoyl hydroxyproline compound may beconverted to its salt for incorporation into the aqueous phase of acompositions.

Prior Publication Data

References Cited [Referenced By]

U.S. Patent Documents

Foreign Patent Documents

Other References

Primary Examiner: Woodward; Michael P.
Assistant Examiner: Silverman; Eric E.
Attorney, Agent or Firm: Addington; Eric T. Howell; John H.Bolam; Brian M.

Claims

What is claimed is:

1. Skin care compositions for regulating the condition of mammaliankeratinous tissue comprising: a) at least 0.01%, by weight of thecomposition, of a dipalmitoyl hydroxyproline salt wherein thedipalmitoryl hydroxyproline salt is a triethanolamine salt; b) asafe and effective amount of a skin care active selected from thegroup consisting of sugar amines, its salts and its derivatives, ahexamidine compound conforming to the structure: ##STR00005##wherein R.sup.1 and R.sup.2 comprise organic acids, and mixturesthereof; and c) a dermatologically acceptable carrier.

2. The skin care composition of claim 1 wherein the weight ratio ofa) to b) is from about 1:12 to about 1:0.1.

3. The skin care composition of claim 1 wherein said compositioncomprises from about 0.1% to about 10%, by weight of thecomposition, of said dipalmitoyl hydroxyproline salt.

4. The skin care composition of claim 3 wherein said dipalmitoylhydroxyproline salt comprises from about 0.1 to 2% by weight of thecomposition.

5. The skin care composition of claim 1 wherein said skin careactive comprises said sugar amines, its salts at a level from about0.1% to about 10.0% by weight of the compositions.

6. The skin care composition of claim 5 wherein said sugar amine isN-acetyl D-glucosamine.

7. The skin care composition of claim 1 wherein said skin careactive comprises said hexamidine compounds comprising from about0.001 to 10.0% by weight of the composition.

8. The skin care composition of claim 7 wherein said hexamidinecompound is diisethionate hexamidine.

9. The skin care composition of claim 1 wherein said skin careactive comprises a combination of said sugar amines, its salts andsaid hexamidine compounds.

10. The skin care composition of claim 9 wherein said sugar amines,its salt and its derivatives if from about 0.1% to about 10.0% andsaid hexamidine compound is from about 0.1% to about 10.0% byweight of the composition.

11. The skin care composition of claim 9 wherein said sugar amineis N-acetyl D-glucosamine and said hexamidine compound isdiisethionate hexamidine.

12. The skin care composition of claim 1 wherein said compositioncomprises from about 0.0001% to about 10%, by weight of thecomposition, of an additional skin care active selected from thegroup consisting of desquamatory actives, anti-acne actives,wrinkle repair actives, anti-oxidants, radical scavengers,chelators, anti-inflammatory agents, topical anesthetics, tanningactives, skin lightening agents, anti-cellulite agents, flavonoids,antimicrobial actives, antifungal actives, sunscreen actives,conditioning agents, and combinations thereof.

13. The skin care composition of claim 12 wherein the skin careactive is selected from the group consisting of Vitamin B.sub.3,its salts; retinoids; peptides; phytosterol and combinationsthereof.

14. The skin care composition of claim 1 wherein the compositionhas a pH from about 4 to about 8.

15. The skin care composition of claim 1 wherein said compositionis an emulsion.

16. A process for making the composition of claim 1 wherein thesalt of the dipalmitoyl hydroxyproline is formed during theprocessing of said composition, said process comprising adding asufficient amount of a basic reagent at a concentration sufficientto convert said dialkanoyl hydroxyproline compound into a desiredlevel of its corresponding salt.

17. A method of regulating the condition of mammalian keratinoustissue, said method comprising the step of topically applying to atreatment surface of the body in need of such treatment thecomposition of claim 1.

18. The method according to claim 17 wherein the condition to beregulated is selected from the group consisting of thickening theskin; reducing skin atrophy, spider vessels, the appearance of redblotchiness on the skin, the appearance of dark under-eye circles,puffy eyes, sallowness of skin, pore size of skin, oily appearanceof skin shiny appearance of skin, hyperpigmentation of skin,sagging of skin, fine lines and wrinkles; reducing dryness ofkeratinous tissue, reducing itching of skin, reducing the roughnessof skin; and combinations thereof.

19. Skin care compositions for regulating the condition ofmammalian keratinaus tissue comprising: a) at least 0.01% by weightof a dipalmitoyl hydroxyproline salt, wherein the dipalmitoylhydroxyproline salt is a triethanolamine salt b) a safe andeffective amount of a sugar amine, its salts and; c) a safe andeffective amount of a hexamidine compound conforming to thestructure; ##STR00006## wherein R.sup.1 and R.sup.2 compriseorganic acids; and d) a dermatologically acceptable carrier.

20. The skin care composition of claim 19 wherein said compositioncomprises from about 0.1% to about 10.0%, by weight of thecomposition, of said sugar amine, its salt, and from about 0.1% toabout 10.0%, by weight of the composition, of said hexarnidine.

21. The skin care composition of claim 19 wherein said sugar amineis N-acetyl D-glucosamine and said hexamidine compound isdiisethionaxe hexamidine.

Description

TECHNICAL FIELD

The present invention relates to topical compositions containing acombination of dialkanoyl hydroxyproline compounds and their saltsand derivatives in combination with hexamidine compounds and theirsalts and derivatives and/or sugar amine compounds and their saltsand derivatives. Such compositions are useful for regulating thecondition of mammalian keratinous tissue using defined dialkanoylhydroxyproline compounds along with at least one additional skincare active selected from hexamidine compounds and sugar aminecompounds. Also disclosed are methods, as outlined below, for suchregulation of keratinous tissue. These cosmetic methods areaccomplished via the topical application, to the skin of a mammalneeding such treatments, compositions containing a) a dialkanoylhydroxyproline compound and at least one additional skin careactive selected from hexamidine compounds and sugar amine compoundsor b) neutralized dialkanoyl hydroxy proline salts incorporatedinto the aqueous phase of either an emulsion or a solution.

BACKGROUND OF THE INVENTION

Currently, there are a number of personal care products that areavailable to consumers, which are directed toward improving thephysical appearance and health of keratinous tissues such as theskin, hair, and nails. The majority of these products are directedto delaying, minimizing or even eliminating skin wrinkling andother histological changes typically associated with the aging ofskin or environmental damage to human skin. Numerous compounds havebeen described in the art as being useful for regulating skincondition, including regulating fine lines, wrinkles, skin texture,sagging and skin discoloration.

Mammalian keratinous tissue, particularly human skin, is subjectedto a variety of insults by both extrinsic and intrinsic factors.Such extrinsic factors include ultraviolet radiation, environmentalpollution, wind, heat, infrared radiation, low humidity, harshsurfactants, abrasives, etc. Intrinsic factors, on the other hand,include chronological aging and other biochemical changes fromwithin the skin. Whether extrinsic or intrinsic, these factorsresult in visible signs of skin damage. Typical skin damageincludes thinning of the skin, which occurs naturally as one ages.With such thinning, there is a reduction in the cells and bloodvessels that supply the skin as well as a flattening of thedermal-epidermal junction that results in weaker mechanicalresistance of this junction. See, for example, Oikarinen, "TheAging of Skin: Chronoaging Versus Photoaging," Photodermatol.Photoimmunol. Photomed., vol. 7, pp. 3-4, 1990. Other damages orchanges seen in aging or damaged skin include fine lines,wrinkling, hyperpigmentation, sallowness, sagging, dark under-eyecircles, puffy eyes, enlarged pores, diminished rate of turnover,and abnormal desquamation or exfoliation. Additional damageincurred as a result of both external and internal factors includesvisible dead skin (i.e., flaking, scaling, dryness, roughness).

Therefore, there is a need for products and methods that seek toremedy these keratinous tissue conditions. A large number of skincare actives are known in the art and used to improve the physicalappearance and/or health of the skin. For example, salicylic acidand benzoyl peroxide are used in skin care compositions to treatacne. Retinoids are another example of skin care actives used inskin care compositions to reduce signs of aging skin. Althoughformulating skin care compositions with such actives provide skincare benefits, there are also challenges in formulating suchcompositions. For example, retinoid compositions typically have tobe prepared under specialized conditions, such as inert atmosphere,and may exhibit less than optimal stability, such as discoloration,at times. Some skin care actives may result in skin irritation,such as stinging, burning and redness.

Based on the foregoing, there is a continuing need to formulateskin care compositions which improve the physical appearance and/orhealth of the skin, which are for example, aesthetically pleasing,stable and effective at treating the appearance of wrinkles, finelines, pores, poor skin color (redness, sallowness and other formsof undesirable skin surface texture).

Surprisingly, it has now been found that compositions containingdialkanoyl hydroxyprolines compounds, their salts and derivativesthereof when in combination with hexamidine compounds, its saltsand derivatives thereof and/or sugar amine compounds, its salts andderivatives thereof provide benefits in regulating skin conditionpreviously unrecognized in the art of which the inventors areaware. For example, topical application of dipalmitoylhydroxyproline and hexamidine and/or N-acetyl glucosamine isbelieved to synergistically regulate (prophylactically and/ortherapeutically) visible and or tactile discontinuities inmammalian skin. Additionally surprising is the fact thatneutralized salts of dialkanoyl hydroxyprolines can be incorporatedinto the aqueous phase of a composition, such as a solution or anemulsion resulting in improved stability of these compositions.

For instance, Applicants have found that such compositions may beuseful for preventing, retarding, and/or treating dark under-eyecircles, puffy eyes, sagging, sallowness as well as spider vesselsand/or red blotchiness of skin, promoting skin desquamation,exfoliation, and/or turnover, regulating and/or reducing pore sizeappearance, preventing/retarding tanning, regulating oily/shinyappearance, preventing, retarding, and/or treatinghyperpigmentation (such as post-inflammatory hyperpigmentation,pigment spots such as age spots, and the like) in mammalian skin,preventing, retarding, and/or treating itchiness of mammalian skin,preventing, retarding, and/or treating dryness of skin, preventing,retarding, and/or treating fine lines and wrinkles, preventing,retarding, and/or treating skin atrophy of mammalian skin,softening and/or smoothing lips, hair and nails of a mammal, andpreventing, retarding, and/or treating the appearance of cellulitein mammalian skin.

SUMMARY OF THE INVENTION

The present invention relates both to the compositions and tomethods for regulating the condition of mammalian keratinous tissuewherein the methods each comprise the step of topically applying tothe keratinous tissue of a mammal needing such treatment, a safeand effective amount of a skin care composition comprising: a) asafe and effective amount of a dialkanoyl hydroxyproline compoundselected from the group consisting of dialkanoyl hydroxyproline,its salts, and derivatives; b) a safe and effective amount of askin care active selected from the group consisting of hexamidinecompounds and salts and derivatives thereof, sugar amine compoundsand their salts and derivatives thereof, and mixtures thereof; andc) a dermatologically acceptable carrier.

Preferably, the weight ratio of the dialkanoyl hydroxyprolinecompound to the hexamidine compound, the sugar amine compound orcombinations thereof is from 1:12 to 1:0.1.

In an additional embodiment the present invention relates tocompositions and to methods for regulating the condition ofmammalian keratinous tissue wherein the methods each comprise thestep of topically applying to the keratinous tissue of a mammalneeding such treatment, a safe and effective amount of a skin carecomposition comprising: a) a safe and effective amount ofdialkanoyl hydroxyproline salts wherein the salt is incorporatedinto the aqueous phase of a composition; and b) a dermatologicallyacceptable carrier for the composition. The composition can beeither a water containing emulsion or an aqueous solution ordispersion.

Upon making oil-in-water emulsions of the present invention, manysuch emulsions will not have sufficient oil present to adequatelysolubilize the oil-soluble dialkanoyl hydroxyproline compoundthat's not in a water-soluble salt form. To facilitatemanufacturing such emulsion compositions, it has been found that aprocess including the initial formation of a dialkanoylhydroxyproline salt simplifies the manufacturing method of makingsuch emulsions.

DETAILED DESCRIPTION OF THE INVENTION

All percentages and ratios used herein are by weight of the totalcomposition and all measurements made are at 25.degree. C., unlessotherwise designated.

The compositions of the present invention can comprise, consistessentially of, or consist of, the essential components as well asoptional ingredients described herein. As used herein, "consistingessentially of" means that the composition or component may includeadditional ingredients, but only if the additional ingredients donot materially alter the basic and novel characteristics of theclaimed compositions or methods.

All documents cited are, in relevant part, incorporated herein byreference; the citation of any document is not to be construed asan admission that it is prior art with respect to the presentinvention.

The term "keratinous tissue," as used herein, refers tokeratin-containing layers disposed as the outermost protectivecovering of mammals which includes, but is not limited to, skin,hair, toenails, fingernails, cuticles, hooves, etc.

The term "topical application", as used herein, means to apply orspread the compositions of the present invention onto the surfaceof the keratinous tissue.

The term "dermatologically acceptable," as used herein, means thatthe compositions or components thereof so described are suitablefor use in contact with human keratinous tissue without unduetoxicity, incompatibility, instability, allergic response, and thelike.

The term "safe and effective amount" as used herein means an amountof a compound or composition sufficient to significantly induce apositive benefit, preferably a positive keratinous tissueappearance or feel benefit, including independently or incombinations the benefits disclosed herein, but low enough to avoidserious side effects, i.e., to provide a reasonable benefit to riskratio, within the scope of sound judgment of the skilledartisan.

The term "post-inflammatory hyperpigmentation" as used hereinrefers to the changes in melanin content as a response to aninflammatory event (e.g., acne, scratch, insect sting, sunburn,etc), especially in dark skin subjects.

The term "derivatives" as used herein refers to structures whichare not shown but which one skilled in the art would understand arevariations of the basic compound. For example, removing a hydrogenatom from benzene and replacing it with a methyl group.

The term "hyperpigmentation" as used herein refers to an area ofskin wherein the pigmentation is greater than that of an adjacentarea of skin (e.g., a pigment spot, an age spot, and the like).

The terms "desquamation, exfoliation, and/or increasing turnover"as used herein mean the removal of the upper layers of the stratumcorneum (comprising the horny layers). Without intending to belimited by theory, it is believed that these benefits may beaccomplished via chemical and physical means that remove theselayers from the top down. Additionally, it is possible to elicitexfoliation via a biological means that drives the turnover of theepidermal layers from the viable layers (e.g., basal layers)upwards. It is believed that this involves the process ofkeratinocyte proliferation and/or as induction of differentiation.The latter leads to an elevation in keratinization levels as well,which ultimately leads to a reorganization of the upper epidermallayers that comprise the spinous and stratum granulosum layers.

The terms "oily and/or shiny appearance" as used herein mean theglossy look mammalian skin tends to exhibit upon the excretion ofoil, sebum, and/or sweat from the respective source gland.

The term "sagging" as used herein means the laxity, slackness, orthe like condition of skin that occurs as a result of loss of,damage to, alterations to, and/or abnormalities in dermalelastin.

The term "smoothing" and "softening" as used herein means alteringthe surface of the keratinous tissue such that its tactile feel isimproved.

The term "sallowness" as used herein means the pale color, yellowcolor or the like condition of skin that occurs as a result of aloss of, damage to, alterations to, and/or abnormalities in skincomponents such that they become colored (e.g., yellow in color)due to processes such as protein glycation and accumulation oflipofuscin or in the decrease in peripheral blood flow thattypically accompanies skin aging.

The compositions of the present invention are useful for topicalapplication and for regulating keratinous tissue condition.Regulation of keratinous tissue condition, especially human skincondition, is often required due to conditions that may be inducedor caused by factors internal and/or external to the body. Forinstance, "regulating skin condition" includes prophylacticallyregulating and/or therapeutically regulating skin condition, andmay involve one or more of the following benefits: thickening(i.e., building the epidermis and/or dermis layers of the skinand/or the subcutaneous layers such as fat and muscle and whereapplicable the keratinous layers of the nail and hair shaft) toreduce atrophy (e.g., of the skin), increasing the convolution ofthe dermal-epidermal border, non-melanin skin discoloration such asunder eye circles, blotching (e.g., uneven red coloration due to,e.g., rosacea) (hereinafter referred to as "red blotchiness"),sallowness (pale or yellow color), discoloration caused bytelangiectasia or spider vessels, discolorations due to melanin(e.g., pigment spots, age spots, uneven pigmentation) and otherchromophores in the skin (e.g., lipofuscin, protein crosslinks suchas those that occur with glycation, and the like). As used herein,prophylactically regulating skin condition includes delaying,minimizing and/or preventing visible and/or tactile discontinuitiesin skin (e.g., texture irregularities, fine lines, wrinkles,sagging, stretch marks, cellulite, puffy eyes, and the like in theskin which may be detected visually or by feel). As used herein,therapeutically regulating skin condition includes ameliorating,e.g., diminishing, minimizing and/or effacing, discontinuities inskin. Regulating skin condition involves improving skin appearanceand/or feel.

As used herein, "regulating skin condition" is intended to includeregulation of such signs irrespective of the mechanism oforigin.

The compositions of the present invention, including the essentialand optional components thereof, are described in detailhereinafter.

I. The Compositions

A. Dialkanoyl Hydroxyproline Compounds

The topical compositions of the present invention comprise a safeand effective amount of one or more dialkanoyl hydroxyprolinecompounds and their salts and derivatives. In the composition ofthe present invention, the dipalmitoyl hydroxyproline compoundspreferably comprise from about 0.01 to 10%, more preferably fromabout 0.1-5%, more and most preferably from about 0.1 to 2% byweight of the composition

Suitable derivatives include but are not limited to esters, forexample fatty esters, including, but not limited to tripalmitoylhydroxyproline and dipalmityl acetyl hydroxyproline. A particularlyuseful compound is dipalmitoyl hydroxyproline. As used herein,dipalnutoyl hydroxyproline" includes any isomers and tautomers ofsuch and is commercially available under the tradename SepiliftDPHP.RTM. from Seppic, Inc. Further discussion of dipalmitoylhydroxy proline appears in PCT Publication WO 93/23028. Preferablythe dipalmitoyl hydroxyproline is the triethanolamine salt ofdipalmitoyl hydroxyproline.

B. Skin Care Actives (Hexamidine and Sugar Amine Compounds)

The composition of the present invention includes use of anadditional skin care active with dialkanoyl hydroxyprolinecompounds disclosed above. This additional skin care active isselected from the group consisting of hexamidine compounds, itssalts and its derivatives, sugar amine compounds, its salts andderivatives and mixtures thereof. Preferably, the weight ratio ofthe dialkanoyl hydroxyproline compound, the sugar amine compound orcombinations thereof is 1:12 to 1.0 to 0.1.

Hexamidine Compounds

The hexamidine compounds useful in the present invention correspondto those of the following chemical structure:

##STR00001## wherein R.sup.1 and R.sup.2 comprise organic acids(e.g., sulfonic acids, etc.).

In the composition of the present invention, the hexamidinecompound preferably comprises from about, 0.001-10%, morepreferably from about 0.01-5%, and most preferably from about0.02-2.5%.

The topical compositions of the present invention optionallyinclude a safe and effective amount of one or more of hexamidinecompounds, its salts and its derivatives. As used herein,hexamidine derivatives includes any isomers and tautomers ofhexamidine compounds including but not limited to organic acids andmineral acids, for example sulfonic acid, carboxylic acid etc.Preferably, the hexamidine compounds include hexamidinediisethionate, commercially available as Elestab.RTM. HP100 fromLaboratoires Serobiologiques (Pulnoy, France).

Sugar Amine Compounds (Amino Sugars)

The compositions of the present invention optionally include a safeand effective amount of a sugar amine, which are also known asamino sugars. The sugar amine compounds useful in the presentinvention are described in PCT Publication WO 02/076423, publishedOct. 3, 2000 and U.S. Pat. No. 6,159,485, issued Dec. 12, 2000.

Preferably, the composition contains from about 0.01% to about 15%,more preferably from about 0.1% to about 10%, and most preferablyfrom about 0.5% to about 5% by weight of the composition, of thesugar amine.

Sugar amines can be synthetic or natural in origin and can be usedas essentially as pure compounds or mixtures of compounds (e.g.,extracts from natural sources or mixtures of synthetic materials).Glucosamine is generally found in many shellfish and can also bederived from fungal sources. As used herein, "sugar amine" includesisomers and tautomers of such and its salts (e.g., HCl salt) andits derivatives and is commercially available from Sigma ChemicalCo., St. Louis, Mo.

Examples of sugar amines that are useful herein includeglucosamine, N-acetyl glucosamine, mannosamine, N-acetylmannosamine, galactosamine, N-acetyl galactosamine, their isomers(e.g., stereoisomers), and their salts (e.g., HCl salt). Preferredfor use herein are glucosamine, particularly D-glucosamine andN-acetyl glucosamine, particularly N-acetyl-D-glucosamine.Additionally, combinations of two or more sugar amines may be used.The topical compositions of the present invention also comprise asafe and effective amount of one or more glucosamine compounds.Most preferred for use herein is N-acetyl D-glucosamine.

C. Dermatologically Acceptable Carrier

The topical compositions of the present invention also comprise adermatologically acceptable carrier for the disclosed compositions.The phrase "dermatologically acceptable carrier", as used herein,means that the carrier is suitable for topical application to thekeratinous tissue, has good aesthetic properties, is compatiblewith the actives of the present invention and any other components,and will not cause any safety or toxicity concerns. A safe andeffective amount of carrier is from about 50% to about 99.99%,preferably from about 60% to about 99.9%, and most preferably fromabout 70% to about 98% of the composition.

The carrier can be in a wide variety of types. For example,emulsion carriers, including, but not limited to, oil-in-water,water-in-oil, water-in-oil-in-water, and oil-in-water-in-oilemulsions, are useful herein. In these emulsion carriers, siliconecan also be used as the oil, thus yielding silicone-in-water,water-in-silicone, water-in-silicone-in-water andoil-in-water-in-silicone emulsions. In addition, water or waterbased carriers are an acceptable carrier for those embodimentscomprising dialkanoyl hydroxyproline salts, while oils or oil-basedcarriers are acceptable carriers for non-salt forms of dialkanoylhydroxyproline. These carriers can also take many forms,non-limiting examples of which include liquids, milks, serums,lotions, creams, sprays, aerosols, mousses, foams, sticks, gels,and pencils.

Preferred carriers comprise an emulsion such as oil-in-wateremulsions, including silicone in-water and water-in-oil emulsions,including water-in-silicone emulsions. As will be understood by theskilled artisan, a given component will distribute primarily intoeither the water or oil phase, depending on the watersolubility/dispensability of the component in the composition.Oil-in-water emulsions are especially preferred, andsilicone-in-water emulsions are even more preferred.

Emulsions according to the present invention generally contain anaqueous solution described above and a lipid or oil. Lipids andoils may be derived from animals, plants, or petroleum and may benatural or synthetic (i.e., man-made, such as silicones). Preferredemulsions also contain a humectant, such as glycerin. Emulsionswill preferably further contain from about 0.05% to about 10%, morepreferably from about 0.1% to about 5%, of an emulsifier, based onthe weight of the composition. Emulsifiers may be nonionic, anionicor cationic. Suitable emulsifiers are disclosed in, for example,U.S. Pat. No. 3,755,560, issued Aug. 28, 1973, Dickert et al.; U.S.Pat. No. 4,421,769, issued Dec. 20, 1983, Dixon et al.; andMcCutcheon's Detergents and Emulsifiers, North American Edition,pages 317-324 (1986).

Suitable emulsions may have a wide range of viscosities, dependingon the desired product form.

Preferred water-in-oil and oil-in-water emulsions are described ingreater detail below.

1) Water-in-Oil Emulsion

Water in oil emulsions are characterized as having a continuoushydrophobic, water insoluble oil phase and a water phase dispersedtherein. The "oil phase" can contain oil, silicone or mixturesthereof. The distinction of whether the emulsion is characterizedas a water-in-oil or water-in-silicone emulsion is a function ofwhether the oil phase is composed of primarily oil or silicone. Apreferred example of a water-in-silicone emulsion is describedbelow.

A. Continuous Silicone Phase

Preferred water-in-silicone emulsions of the present inventioncomprise from about 1% to about 60%, preferably from about 5% toabout 40%, more preferably from about 10% to about 30%, by weightof a continuous silicone phase. The continuous silicone phaseexists as an external phase that contains or surrounds thediscontinuous aqueous phase described hereinafter.

The continuous silicone phase contains an silicone elastomer and orpolyorganosiloxane oil. The continuous silicone phase of thesepreferred emulsions comprises between about 50% and about 99.9% byweight of organopolysiloxane oil and less than about 50% by weightof a non-silicone oil. In a preferred embodiment, the continuoussilicone phase comprises at least about 50%, preferably from about60% to about 99.9%, more preferably from about 70% to about 99.9%,and even more preferably from about 80% to about 99.9%,polyorganosiloxane oil by weight of the continuous silicone phase,and up to about 50% non-silicone oils, preferably less about 40%,more preferably less than about 30%, even more preferably less thanabout 10%, and most preferably less than about 2%, by weight of thecontinuous silicone phase.

1) Polyorganopolysiloxane Oil

The organopolysiloxane oil for use in the composition may bevolatile, non-volatile, or a mixture of volatile and non-volatilesilicones. The term "nonvolatile" as used in this context refers tothose silicones that are liquid under ambient conditions and have aflash point (under one atmospheric of pressure) of or greater thanabout 100.degree. C. The term "volatile" as used in this contextrefers to all other silicone oils. Suitable organopolysiloxanes canbe selected from a wide variety of silicones spanning a broad rangeof volatilities and viscosities. Examples of suitableorganopolysiloxane oils include polyalkylsiloxanes, cyclicpolyalkylsiloxanes, and polyalkylarylsiloxanes.

Polyalkylsiloxanes useful in the composition herein includepolyalkylsiloxanes with viscosities of from about 0.5 to about1,000,000 centistokes at 25.degree. C. Such polyalkylsiloxanes canbe represented by the general chemical formulaR.sub.3SiO[R.sub.2SiO].sub.xSiR.sub.3 wherein R is an alkyl grouphaving from one to about 30 carbon atoms (preferably R is methyl orethyl, more preferably methyl; also mixed alkyl groups can be usedin the same molecule), and x is an integer from 0 to about 10,000,chosen to achieve the desired molecular weight which can range toover about 10,000,000. Commercially available polyalkylsiloxanesinclude the polydimethylsiloxanes, which are also known asdimethicones, examples of which include the Vicasil.RTM. seriessold by General Electric Company and the Dow Corning.RTM. 200series sold by Dow Corning Corporation. Specific examples ofsuitable polydimethylsiloxanes include Dow Corning.RTM. 200 fluidhaving a viscosity of 0.65 centistokes and a boiling point of100.degree. C., Dow Corning.RTM. 225 fluid having a viscosity of 10centistokes and a boiling point greater than 200.degree. C., andDow Corning.RTM. 200 fluids having viscosities of 50, 350, and12,500 centistokes, respectively, and boiling points greater than200.degree. C. Suitable dimethicones include those represented bythe chemical formula(CH.sub.3).sub.3SiO[(CH.sub.3).sub.2SiO].sub.x[CH.sub.3RSiO].sub.ySi(CH.s-ub.3).sub.3 wherein R is straight or branched chain alkyl havingfrom two to about 30 carbon atoms and x and y are each integers of1 or greater selected to achieve the desired molecular weight whichcan range to over about 10,000,000. Examples of thesealkyl-substituted dimethicones include cetyl dimethicone and lauryldimethicone.

Cyclic polyalkylsiloxanes suitable for use in the compositioninclude those represented by the chemical formula[SiR.sub.2--O].sub.n wherein R is an alkyl group (preferably R ismethyl or ethyl, more preferably methyl) and n is an integer fromabout 3 to about 8, more preferably n is an integer from about 3 toabout 7, and most preferably n is an integer from about 4 to about6. When R is methyl, these materials are typically referred to ascyclomethicones. Commercially available cyclomethicones include DowCorning.RTM. 244 fluid having a viscosity of 2.5 centistokes, and aboiling point of 172.degree. C., which primarily contains thecyclomethicone tetramer (i.e. n=4), Dow Corning.RTM. 344 fluidhaving a viscosity of 2.5 centistokes and a boiling point of178.degree. C., which primarily contains the cyclomethiconepentamer (i.e. n=5), Dow Corning.RTM. 245 fluid having a viscosityof 4.2 centistokes and a boiling point of 205.degree. C., whichprimarily contains a mixture of the cyclomethicone tetramer andpentamer (i.e. n=4 and 5), and Dow Corning.RTM. 345 fluid having aviscosity of 4.5 centistokes and a boiling point of 217.degree.,which primarily contains a mixture of the cyclomethicone tetramer,pentamer, and hexamer (i.e. n=4, 5, and 6).

Also useful are materials such as trimethylsiloxysilicate, which isa polymeric material corresponding to the general chemical formula[(CH.sub.2).sub.3SiO.sub.1/2].sub.x[SiO.sub.2].sub.y, wherein x isan integer from about 1 to about 500 and y is an integer from about1 to about 500. A commercially available trimethylsiloxysilicate issold as a mixture with dimethicone as Dow Corning.RTM. 593fluid.

Dimethiconols are also suitable for use in the composition. Thesecompounds can be represented by the chemical formulasR.sub.3SiO[R.sub.2SiO].sub.xSiR.sub.2OH andHOR.sub.2SiO[R.sub.2SiO].sub.xSiR.sub.2OH wherein R is an alkylgroup (preferably R is methyl or ethyl, more preferably methyl) andx is an integer from 0 to about 500, chosen to achieve the desiredmolecular weight. Commercially available dimethiconols aretypically sold as mixtures with dimethicone or cyclomethicone (e.g.Dow Corning.RTM. 1401, 1402, and 1403 fluids).

Polyalkylaryl siloxanes are also suitable for use in thecomposition. Polymethylphenyl siloxanes having viscosities fromabout 15 to about 65 centistokes at 25.degree. C. are especiallyuseful.

Preferred for use herein are organopolysiloxanes selected from thegroup consisting of polyalkylsiloxanes, alkyl substituteddimethicones, cyclomethicones, trimethylsiloxysilicates,dimethiconols, polyalkylaryl siloxanes, and mixtures thereof. Morepreferred for use herein are polyalkylsiloxanes andcyclomethicones. Preferred among the polyalkylsiloxanes aredimethicones.

As stated above, the continuous silicone phase may contain one ormore non-silicone oils. Suitable non-silicone oils have a meltingpoint of about 25.degree. C. or less under about one atmosphere ofpressure. Examples of non-silicone oils suitable for use in thecontinuous silicone phase are those well known in the chemical artsin topical personal care products in the form of water-in-oilemulsions, e.g., mineral oil, vegetable oils, synthetic oils,semisynthetic oils, etc.

2) Silicone Elastomer

The compositions of the present invention also include from about0.1% to about 30%, by weight of the composition, of a siliconeelastomer component. Preferably, the composition includes fromabout 1% to about 20%, more preferably from about 2% to about 10%,by weight of the composition, of the silicone elastomercomponent.

Suitable for use herein are silicone elastomers, which can beemulsifying or non-emulsifying crosslinked siloxane elastomers ormixtures thereof. No specific restriction exists as to the type ofcurable organopolysiloxane composition which can serve as startingmaterial for the crosslinked organopolysiloxane elastomer. Examplesin this respect are addition reaction-curing organopolysiloxanecompositions which cure under platinum metal catalysis by theaddition reaction between SiH-containing diorganopolysiloxane andorganopolysiloxane having silicon-bonded vinyl groups;condensation-curing organopolysiloxane compositions which cure inthe presence of an organotin compound by a dehydrogenation reactionbetween hydroxyl-terminated diorganopolysiloxane and SiH-containingdiorganopolysiloxane; condensation-curing organopolysiloxanecompositions which cure in the presence of an organotin compound ora titanate ester, by a condensation reaction between anhydroxyl-terminated diorganopolysiloxane and a hydrolyzableorganosilane (this condensation reaction is exemplified bydehydration, alcohol-liberating, oxime-liberating,amine-liberating, amide-liberating, carboxyl-liberating, andketone-liberating reactions); peroxide-curing organopolysiloxanecompositions which thermally cure in the presence of anorganoperoxide catalyst; and organopolysiloxane compositions whichare cured by high-energy radiation, such as by gamma-rays,ultraviolet radiation, or electron beams.

Addition reaction-curing organopolysiloxane compositions arepreferred for their rapid curing rates and excellent uniformity ofcuring. A particularly preferred addition reaction-curingorganopolysiloxane composition is prepared from:

(A) an organopolysiloxane having at least 2 lower alkenyl groups ineach molecule;

(B) an organopolysiloxane having at least 2 silicon-bonded hydrogenatoms in each molecule; and

(C) a platinum-type catalyst.

With regard to the above, component (A) is the basic component ofthe silicone elastomer-generating organopolysiloxane, and curingproceeds by the addition reaction of this component with component(B) under catalysis by component (C). This component (A) mustcontain at least 2 silicon-bonded lower alkenyl groups in eachmolecule; an excellent cured product will not be obtained at fewthan two lower alkenyl groups because a network structure will notbe formed. Said lower alkenyl groups are exemplified by vinyl,allyl, and propenyl. While the lower alkenyl groups can be presentat any position in the molecular, their presence at the molecularterminals is preferred. The molecular structure of this componentmay be straight chain, branched straight chain, cyclic, or network,but a straight chain, possibly slightly branched, is preferred. Themolecular weight of the component is not specifically restricted,and thus the viscosity may range from low viscosity liquids to veryhigh viscosity gums. In order for the cured product to be obtainedin the form of the rubbery elastomer, it is preferred that theviscosity at 25 degrees Centigrade be at least 100 centistokes.These organopolysiloxanes are exemplified by methylvinylsiloxanes,methylvinylsiloxane-dimethylsiloxane copolymers,dimethylvinylsiloxy-terminated dimethylpolysiloxanes,dimethylvinylsiloxy-terminateddimethylsiloxane-methylphenylsiloxane copolymers,dimethylvinylsiloxy-terminateddimethylsiloxane-diphenylsiloxane-methylvinylsiloxane copolymers,trimethylsiloxy-terminated dimethylsiloxane-methylvinylsiloxanecopolymers, trimethylsiloxy-terminateddimethylsiloxane-methylphenylsiloxane-methylvinylsiloxanecopolymers, dimethylvinylsiloxy-terminatedmethyl(3,3,3-trifluoropropyl) polysiloxanes, anddimethylvinylsiloxy-terminateddimethylsiloxane-methyl(3,3,-trifluoropropyl)siloxanecopolymers.

Component (B) is an organopolysiloxane having at least 2silicon-bonded hydrogen atoms in each molecule and is a crosslinkerfor component (A). Curing proceeds by the addition reaction of thesilicon-bonded hydrogen atoms in this component with the loweralkenyl groups in component (A) under catalysis by component (C).This component (B) must contain at least 2 silicon-bonded hydrogenatoms in each molecule in order to function as a crosslinker.Furthermore, the sum of the number of alkenyl groups in eachmolecule of component (A) and the number of silicon-bonded hydrogenatoms in each molecule of component (B) is to be at least 5. Valuesbelow 5 should be avoided because a network structure is thenessentially not formed.

No specific restriction exists on the molecular structure of thiscomponent, and it may be any of straight chain, branch-containingstraight chain, cyclic, etc. The molecular weight of this componentis not specifically restricted, but it is preferred that theviscosity at 25 degrees Centigrade be 1 to 50,000 centistokes inorder to obtain good miscibility with component (A). It ispreferred that this component be added in a quantity such that themolar ratio between the total quantity of silicon-bonded hydrogenatoms in the instant component and the total quantity of all loweralkenyl groups in component (A) falls within the range of (1.5:1)to (20:1). It is difficult to obtain good curing properties whenthis molar ratio falls below 0.5:1. When (20:1) is exceeded, thereis a tendency for the hardness to increase to high levels when thecured product is heated. Furthermore, when an organosiloxanecontaining substantial alkenyl is supplementarily added for thepurpose of; for example, reinforcement, it is preferred that asupplemental addition of the instant SiH-containing component bemade in a quantity offsetting these alkenyl groups. This componentis concretely exemplified by trimethylsiloxy-terminatedmethylhydrogenpolysiloxanes, trimethylsiloxy-terminateddimethylsiloxane-methylhydrogensiloxane copolymers, anddimethylsiloxane-methylhydrogen-siloxane cyclic copolymers.

Component (C) is a catalyst of the addition reaction ofsilicon-bonded hydrogen atoms and alkenyl groups, and is concretelyexemplified by chloroplatinic acid, possibly dissolved in analcohol or ketone and this solution optionally aged, chloroplatinicacid-olefin complexes, chloroplatinic acid-alkenylsiloxanecomplexes, chloroplatinic acid-diketone complexes, platinum black,and carrier-supported platinum.

Component C is added preferably at 0.1 to 1,000 weight parts, andmore preferably at 1 to 100 weight parts, as platinum-type metalproper per 1,000,000 weight parts of the total quantity ofcomponents (A) plus (B). Other organic groups which may be bondedto silicon in the organopolysiloxane forming the basis for theabove-described curable organopolysiloxane compositions are, forexample, alkyl groups such as methyl, ethyl, propyl, butyl, andoctyl; substituted alkyl groups such as 2-phenylethyl,2-phenylpropyl, and 3,3,3-trifluoropropyl; aryl groups such asphenyl, tolyl, and xylyl; substituted aryl groups such asphenylethyl; and monovalent hydrocarbon groups substituted by, forexample, the epoxy group, the carboxylate ester group, the mercaptogroup, etc.

Examples of the production of the organopolysiloxane elastomerpowder are as follows: an organopolysiloxane composition asdescribed above (additional-curable, condensation-curable, orperoxide-curable) is mixed with water in the presence of asurfactant (nonionic, anionic, cationic, or amphoteric), and, aftermixing to homogeneity in a homomixer, colloid mill, homogenizer,propeller mixer, etc., this is cured by discharge into hot water(temperature at least 50 degrees Centigrade) and is then dried; theorganopolysiloxane composition (addition-curable,condensation-curable, or peroxide-curable) is cured by spraying itdirectly into a heated current; the powder is obtained by curing aradiation-curable organopolysiloxane composition by spraying itunder high energy radiation; the organopolysiloxane composition(addition-curable, condensation-curable, peroxide-curable) or highenergy-curable organopolysiloxane composition is cured, the latterby high energy radiation, and the product is then pulverized usinga known pulverizer such as, for example, a ball mill, atomizer,kneader, roll mill, etc., to thereby form the powder.

The compositions of the present invention may include anemulsifying crosslinked organopolysiloxane elastomer, anon-emulsifying crosslinked organopolysiloxane elastomer, or amixture thereof. The term "non-emulsifying," as used herein,defines crosslinked organopolysiloxane elastomers from whichpolyoxyalkylene units are absent. The term "emulsifying," as usedherein, means crosslinked organopolysiloxane elastomers having atleast one polyoxyalkylene (e.g., polyoxyethylene orpolyoxypropylene) unit. Preferred emulsifying elastomers hereininclude polyoxyalkylene modified elastomers formed from divinylcompounds, particularly siloxane polymers with at least two freevinyl groups, reacting with Si--H linkages on a polysiloxanebackbone. Preferably, the elastomers are dimethyl polysiloxanescrosslinked by Si--H sites on a molecularly spherical MQ resin.Emulsifying crosslinked organopolysiloxane elastomer can notably bechosen from the crosslinked polymers described in U.S. Pat. No.5,412,004 (issued May 12, 1995); U.S. Pat. No. 5,837,793 (issuedNov. 17, 1998); and U.S. Pat. No. 5,811,487 (issued Sep. 22, 1998),all of which are herein incorporated by reference in theirentirety. In addition, an emulsifying elastomer comprised ofdimethicone copolyol crosspolymer (and) dimethicone is availablefrom Shin Etsu under the tradename KSG-21.

The silicone elastomers of the present invention may be furtherprocessed by subjecting them to a high shear (approximately 5,000psi) treatment in the presence of a solvent for the siliconeelastomer via a Sonolator with or without recycling in from 1 to 60passes in order to result in a particular average particle size ofsilicone elastomer. Less than 10 passes results in an averageparticle size ranging from about 20 to 200 microns. From 10 to 60passes results in an average particle size of less than 20 micronsas measured by the Horiba LA-910. As used herein, the term"particle size" of the elastomer represents the elastomer particlesize in its swelled state. By "swelled," as used herein, means thethat the elastomer particles have extended beyond their normal sizeand shape by virtue of their absorption of the solventcompound.

Advantageously, the non-emulsifying elastomers aredimethicone/vinyl dimethicone crosspolymers. Such dimethicone/vinyldimethicone crosspolymers are supplied by a variety of suppliersincluding Dow Corning (DC 9040 and DC 9041), General Electric (SFE839), Shin Etsu (KSG-15, 16, 18 [dimethicone/phenyl vinyldimethicone crosspolymer]), and Grant Industries (GRANSIL.TM. lineof elastomers). Cross-linked organopolysiloxane elastomers usefulin the present invention and processes for making them are furtherdescribed in U.S. Pat. No. 4,970,252 to Sakuta, et al., issued Nov.13, 1990; U.S. Pat. No. 5,760,116 to Kilgour, et al., issued Jun.2, 1998; U.S. Pat. No. 5,654,362 to Schulz, Jr., et al. issued Aug.5, 1997, all of which are herein incorporated by reference.Additional crosslinked organopolysiloxane elastomers useful in thepresent invention are disclosed in Japanese Patent Application JP61-18708, assigned to Pola Kasei Kogyo KK.

Commercially available elastomers preferred for use herein are DowCorning's 9040 silicone elastomer blend, Shin Etsu's KSG-21, andmixtures thereof

3) Carrier for Silicone Elastomer

The topical compositions of the present invention include fromabout 1% to about 80%, by weight of the composition, of a suitablecarrier for the for the crosslinked organopolysiloxane elastomercomponent described above. The carrier, when combined with thecross-linked organopolysiloxane elastomer particles of the presentinvention, serves to suspend and swell the elastomer particles toprovide an elastic, gel-like network or matrix. The carrier for thecross-linked siloxane elastomer is liquid under ambient conditions,and preferably has a low viscosity to provide for improvedspreading on the skin.

Concentrations of the carrier in the cosmetic compositions of thepresent invention will vary primarily with the type and amount ofcarrier and the cross-linked siloxane elastomer employed. Preferredconcentrations of the carrier are from about 5% to about 50%, morepreferably from about 5% to about 40%, by weight of thecomposition.

The carrier for the cross-linked siloxane elastomer includes one ormore liquid carriers suitable for topical application to humanskin. These liquid carriers may be organic, silicone-containing orfluorine-containing, volatile or non-volatile, polar or non-polar,provided that the liquid carrier forms a solution or otherhomogenous liquid or liquid dispersion with the selectedcross-linked siloxane elastomer at the selected siloxane elastomerconcentration at a temperature of from about 28.degree. C. to about250.degree. C., preferably from about 28.degree. C. to about100.degree. C., preferably from about 28.degree. C. to about78.degree. C. The carrier for the cross-linked siloxane elastomerpreferably has a solubility parameter of from about 3 to about 13(cal/cm.sup.3).sup.0.5, more preferably from about 5 to about 11(cal/cm.sup.3).sup.0.5, most preferably from about 5 to about 9(cal/cm.sup.3).sup.0.5. Solubility parameters for the liquidcarriers or other materials, and means for determining suchparameters, are well known in the chemical arts. A description ofsolubility parameters and means for determining them are describedby C. D. Vaughan, "Solubility Effects in Product, Package,Penetration and Preservation" 103 Cosmetics and Toiletries 47-69,October 1988; and C. D. Vaughan, "Using Solubility Parameters inCosmetics Formulation", 36 J. Soc. Cosmetic Chemists 319-333,September/October, 1988, which articles are incorporated herein byreference.

The carrier preferably includes volatile, non-polar oils;non-volatile, relatively polar oils; non-volatile, non-polar oils;and non-volatile paraffinic hydrocarbon oils; each discussed morefully hereinafter. The term "non-volatile" as used herein refers tomaterials which exhibit a vapor pressure of no more than about 0.2mm Hg at 25.degree. C. at one atmosphere and/or to materials whichhave a boiling point at one atmosphere of at least about300.degree. C. The term "volatile" as used herein refers to allmaterials which are not "non-volatile" as previously definedherein. The phrase "relatively polar" as used herein means morepolar than another material in terms of solubility parameter; i.e.,the higher the solubility parameter the more polar the liquid. Theterm "non-polar" typically means that the material has a solubilityparameter below about 6.5 (cal/cm.sup.3).sup.0.5.

1. Non-polar, Volatile Oils

The non-polar, volatile oil tends to impart highly desirableaesthetic properties to the compositions of the present invention.Consequently, the non-polar, volatile oils are preferably utilizedat a fairly high level. Non-polar, volatile oils particularlyuseful in the present invention are silicone oils; hydrocarbons;and mixtures thereof. Such non-polar, volatile oils are disclosed,for example, in Cosmetics, Science, and Technology, Vol. 1, 27-104edited by Balsam and Sagarin, 1972. The non-polar, volatile oilsuseful in the present invention may be either saturated orunsaturated, have an aliphatic character and be straight orbranched chained or contain alicyclic or aromatic rings. Examplesof preferred non-polar, volatile hydrocarbons include polydecanessuch as isododecane and isodecane (e.g., Permethyl-99A which isavailable from Presperse Inc.) and the C7-C8 through C12-C15isoparaffins (such as the Isopar Series available from ExxonChemicals). Non-polar, volatile liquid silicone oils are disclosedin U.S. Pat. No. 4,781,917 issued to Luebbe et al. on Nov. 1, 1988,herein incorporated by reference in its entirety. Additionally, adescription of various volatile silicones materials is found inTodd et al., "Volatile Silicone Fluids for Cosmetics", Cosmeticsand Toiletries, 91:27-32 (1976), herein incorporated by referencein its entirety. Particularly preferred volatile silicone oils areselected from cyclic volatile silicones corresponding to theformula:

##STR00002## wherein n is from about 3 to about 7; and linearvolatile silicones corresponding to the formula: (CH.sub.3).sub.3Si--O--[Si(CH.sub.3).sub.2--O].sub.m--Si(CH.sub.3).sub.3 wherein mis from about 1 to about 7. Linear volatile silicones generallyhave a viscosity of less than about 5 centistokes at 25.degree. C.,whereas the cyclic silicones have viscosities of less than about 10centistokes at 25.degree. C. Highly preferred examples of volatilesilicone oils include cyclomethicones of varying viscosities, e.g.,Dow Corning 200, Dow Corning 244, Dow Corning 245, Dow Corning 344,and Dow Corning 345, (commercially available from Dow CorningCorp.); SF-1204 and SF-1202 Silicone Fluids (commercially availablefrom G.E. Silicones), GE 7207 and 7158 (commercially available fromGeneral Electric Co.); and SWS-03314 (commercially available fromSWS Silicones Corp.).

2. Relatively Polar, Non-Volatile Oils

The non-volatile oil is "relatively polar" as compared to thenon-polar, volatile oil discussed above. Therefore, thenon-volatile co-carrier is more polar (i.e., has a highersolubility parameter) than at least one of the non-polar, volatileoils. Relatively polar, non-volatile oils potentially useful in thepresent invention are disclosed, for example, in Cosmetics,Science, and Technology, Vol. 1, 27-104 edited by Balsam andSagarin, 1972; U.S. Pat. No. 4,202,879 issued to Shelton on May 13,1980; and U.S. Pat. No. 4,816,261 issued to Luebbe et al. on Mar.28, 1989, all of which are herein incorporated by reference intheir entirety. Relatively polar, non-volatile oils useful in thepresent invention are preferably selected from silicone oils;hydrocarbon oils; fatty alcohols; fatty acids; esters of mono anddibasic carboxylic acids with mono and polyhydric alcohols;polyoxyethylenes; polyoxypropylenes; mixtures of polyoxyethyleneand polyoxypropylene ethers of fatty alcohols; and mixturesthereof. The relatively polar, non-volatile co-carriers useful inthe present invention may be either saturated or unsaturated, havean aliphatic character and be straight or branched chained orcontain alicyclic or aromatic rings. More preferably, therelatively polar, non-volatile liquid co-carrier is selected fromfatty alcohols having from about 12-26 carbon atoms; fatty acidshaving from about 12-26 carbon atoms; esters of monobasiccarboxylic acids and alcohols having from about 14-30 carbon atoms;esters of dibasic carboxylic acids and alcohols having from about10-30 carbon atoms; esters of polyhydric alcohols and carboxylicacids having from about 5-26 carbon atoms; ethoxylated,propoxylated, and mixtures of ethoxylated and propoxylated ethersof fatty alcohols with from about 12-26 carbon atoms and a degreeof ethoxylation and propoxylation of below about 50; and mixturesthereof. More preferred are propoxylated ethers of C14-C18 fattyalcohols having a degree of propoxylation below about 50, esters ofC2-C8 alcohols and C12-C26 carboxylic acids (e.g. ethyl myristate,isopropyl palmitate), esters of C12-C26 alcohols and benzoic acid(e.g. Finsolv TN supplied by Finetex), diesters of C.sub.2-C.sub.8alcohols and adipic, sebacic, and phthalic acids (e.g., diisopropylsebacate, diisopropyl adipate, di-n-butyl phthalate), polyhydricalcohol esters of C6-C26 carboxylic acids (e.g., propylene glycoldicaprate/dicaprylate, propylene glycol isostearate); and mixturesthereof. Even more preferred are branched-chain aliphatic fattyalcohols having from about 12-26 carbon atoms. Even more preferredis isocetyl alcohol, octyldecanol, octyldodecanol andundecylpentadecanol; and most preferred is octyldodecanol. Suchpreferred aliphatic fatty alcohols are particularly useful incombination with the volatile liquid silicone oils discussed hereinto adjust the average solubility of the carrier.

3. Non-Polar, Non-Volatile Oils

In addition to the liquids discussed above, the carrier for thecross-linked siloxane elastomer may optionally includenon-volatile, non-polar oils. Typical non-volatile, non-polaremollients are disclosed, for example, in Cosmetics, Science, andTechnology, Vol. 1, 27-104 edited by Balsam and Sagarin, 1972; U.S.Pat. No. 4,202,879 issued to Shelton on May 13, 1980; and U.S. Pat.No. 4,816,261 issued to Luebbe et al. on Mar. 28, 1989. Both ofwhich are herein incorporated by reference. The non-volatile oilsuseful in the present invention are essentially non-volatilepolysiloxanes, paraffinic hydrocarbon oils, and mixtures thereof.The polysiloxanes useful in the present invention selected frompolyalkylsiloxanes, polyarylsiloxanes, polyalkylarylsiloxanes,poly-ethersiloxane copolymers, and mixtures thereof. Examples ofthese include polydimethyl siloxanes having viscosities of fromabout 1 to about 100,000 centistokes at 25.degree. C. Among thepreferred non-volatile silicone emollients useful in the presentcompositions are the polydimethyl siloxanes having viscosities fromabout 2 to about 400 centistokes at 25.degree. C. Suchpolyalkylsiloxanes include the Viscasil series (sold by GeneralElectric Company) and the Dow Corning 200 series (sold by DowCorning Corp.). Polyalkylarylsiloxanes include polymethylphenylsiloxanes having viscosities of from about 15 to about 65centistokes at 25.degree. C. These are available, for example, asSF 1075 methyl-phenyl fluid (sold by General Electric Company) and556 Cosmetic Grade Fluid (sold by Dow Corning Corp.). Usefulpolyethersiloxane copolymers include, for example, apolyoxyalkylene ether copolymer having a viscosity of about 1200 to1500 centistokes at 25.degree. C. Such a fluid is available asSF1066 organosilicone surfactant (sold by General ElectricCompany). Polysiloxane ethylene glycol ether copolymers arepreferred copolymers for use in the present compositions.

Non-volatile paraffinic hydrocarbon oils useful in the presentinvention include mineral oils and certain branched-chainhydrocarbons. Examples of these fluids are disclosed in U.S. Pat.No. 5,019,375 issued to Tanner et al. on May 28, 1991, hereinincorporated by reference in its entirety. Preferred mineral oilshave the following properties:

(1) viscosity from about 5 centistokes to about 70 centistokes at40.degree. C.;

(2) density between about 0.82 and 0.89 g/cm3 at 25.degree. C.;

(3) flash point between about 138.degree. C. and about 216.degree.C.; and

(4) carbon chain length between about 14 and about 40 carbonatoms.

Preferred branched chain hydrocarbon oils have the followingproperties:

(1) density between about 0.79 and about 0.89 g/cm3 at 20.degree.C.

(2) boiling point greater than about 250.degree. C.; and

(3) flash point between about 110.degree. C. and about 200.degree.C.

Particularly preferred branched-chain hydrocarbons includePermethyl 103 A, which contains an average of about 24 carbonatoms; Permethyl 104A, which contains an average of about 68 carbonatoms; Permethyl 102A, which contains an average of about 20 carbonatoms; all of which may be purchased from Permethyl Corporation;and Ethylflo 364 which contains a mixture of 30 carbon atoms and 40carbon atoms and may be purchased from Ethyl Corp.

Additional carriers useful herein include solvents described inU.S. Pat. No. 5,750,096 to Gerald J. Guskey et al., issued May 12,1998, herein incorporated by reference in its entirety.

(B) Dispersed Aqueous Phase

The topical compositions of the present invention comprise fromabout 30% to about 90%, more preferably from about 50% to about85%, and most preferably from about 70% to about 80% of a dispersedaqueous phase. In emulsion technology, the term "dispersed phase"is a term well-known to one skilled in the art which means that thephase exists as small particles or droplets that are suspended inand surrounded by a continuous phase. The dispersed phase is alsoknown as the internal or discontinuous phase. The dispersed aqueousphase is a dispersion of small aqueous particles or dropletssuspended in and surrounded by the continuous silicone phasedescribed hereinbefore.

The aqueous phase can be water, or a combination of water and oneor more water soluble or dispersible ingredients. Nonlimitingexamples of such optional ingredients include thickeners, acids,bases, salts, chelants, gums, water-soluble or dispersible alcoholsand polyols, buffers, preservatives, sunscreening agents,colorings, and the like.

The topical compositions of the present invention will typicallycomprise from about 25% to about 90%, preferably from about 40% toabout 80%, more preferably from about 60% to about 80%, water inthe dispersed aqueous phase by weight of the composition.

(1) Emulsifier for Dispersing the Aqueous Phase

The water-in-silicone emulsions of the present invention preferablycomprise an emulsifier. In a preferred embodiment, the compositioncontains from about 0.1% to about 10% emulsifier, more preferablyfrom about 0.5% to about 7.5%, most preferably from about 1% toabout 5%, emulsifier by weight of the composition. The emulsifierhelps disperse and suspend the aqueous phase within the continuoussilicone phase.

A wide variety of emulsifying agents can be employed herein to formthe preferred water-in-silicone emulsion. Known or conventionalemulsifying agents can be used in the composition, provided thatthe selected emulsifying agent is chemically and physicallycompatible with essential components of the composition, andprovides the desired dispersion characteristics. Suitableemulsifiers include silicone emulsifiers, non-silicon-containingemulsifiers, and mixtures thereof, known by those skilled in theart for use in topical personal care products. Preferably theseemulsifiers have an HLB value of or less than about 14, morepreferably from about 2 to about 14, and most preferably from about4 to about 14. Emulsifiers having an HLB value outside of theseranges can be used in combination with other emulsifiers to achievean effective weighted average HLB for the combination that fallswithin these ranges.

Silicone emulsifiers are preferred. A wide variety of siliconeemulsifiers are useful herein. These silicone emulsifiers aretypically organically modified organopolysiloxanes, also known tothose skilled in the art as silicone surfactants. Useful siliconeemulsifiers include dimethicone copolyols. These materials arepolydimethylsiloxanes that have been modified to include polyetherside chains such as polyethylene oxide chains, polypropylene oxidechains, mixtures of these chains, and polyether chains containingmoieties derived from both ethylene oxide and propylene oxide.Other examples include alkyl-modified dimethicone copolyols, i.e.,compounds that contain C2-C30 pendant side chains. Still otheruseful dimethicone copolyols include materials having variouscationic, anionic, amphoteric, and zwitterionic pendantmoieties.

The dimethicone copolyol emulsifiers useful herein can be describedby the following general structure:

##STR00003## wherein R is C1-C30 straight, branched, or cyclicalkyl and R.sup.2 is selected from the group consisting of:--(CH.sub.2).sub.n--O--(CH.sub.2CHR.sup.3O).sub.m--H, and--(CH.sub.2).sub.n--O--(CH.sub.2CHR.sup.3O).sub.m--(CH.sub.2CHR.sup.4O).s-ub.o--H, wherein n is an integer from 3 to about 10; R.sup.3 andR.sup.4 are selected from the group consisting of H and C1-C6straight or branched chain alkyl such that R.sup.3 and R.sup.4 arenot simultaneously the same; and m, o, x, and y are selected suchthat the molecule has an overall molecular weight from about 200 toabout 10,000,000, with m, o, x, and y being independently selectedfrom integers of zero or greater such that m and o are not bothsimultaneously zero, and z being independently selected fromintegers of 1 or greater. It is recognized that positional isomersof these copolyols can be achieved. The chemical representationsdepicted above for the R.sup.2 moieties containing the R.sup.3 andR.sup.4 groups are not meant to be limiting but are shown as suchfor convenience.

Also useful herein, although not strictly classified as dimethiconecopolyols, are silicone surfactants as depicted in the structuresin the previous paragraph wherein R.sup.2 is:--(CH.sub.2).sub.n--O--R.sup.5, wherein R.sup.5 is a cationic,anionic, amphoteric, or zwitterionic moiety.

Nonlimiting examples of dimethicone copolyols and other siliconesurfactants useful as emulsifiers herein includepolydimethylsiloxane polyether copolymers with pendant polyethyleneoxide side chains, polydimethylsiloxane polyether copolymers withpendant polypropylene oxide side chains, polydimethylsiloxanepolyether copolymers with pendant mixed polyethylene oxide andpolypropylene oxide side chains, polydimethylsiloxane polyethercopolymers with pendant mixed poly(ethylene)(propylene)oxide sidechains, polydimethylsiloxane polyether copolymers with pendantorganobetaine side chains, polydimethylsiloxane polyethercopolymers with pendant carboxylate side chains,polydimethylsiloxane polyether copolymers with pendant quaternaryammonium side chains; and also further modifications of thepreceding copolymers containing pendant C2-C30 straight, branched,or cyclic alkyl moieties. Examples of commercially availabledimethicone copolyols useful herein sold by Dow Corning Corporationare Dow Corning.RTM. 190, 193, Q2-5220, 2501 Wax, 2-5324 fluid, and3225C (this latter material being sold as a mixture withcyclomethicone). Cetyl dimethicone copolyol is commerciallyavailable as a mixture with polyglyceryl-4 isostearate (and) hexyllaurate and is sold under the tradename ABIL.RTM. WE-09 (availablefrom Goldschmidt). Cetyl dimethicone copolyol is also commerciallyavailable as a mixture with hexyl laurate (and) polyglyceryl-3oleate (and) cetyl dimethicone and is sold under the tradenameABIL.RTM. WS-08 (also available from Goldschmidt). Othernonlimiting examples of dimethicone copolyols also include lauryldimethicone copolyol, dimethicone copolyol acetate, diemethiconecopolyol adipate, dimethicone copolyolamine, dimethicone copolyolbehenate, dimethicone copolyol butyl ether, dimethicone copolyolhydroxy stearate, dimethicone copolyol isostearate, dimethiconecopolyol laurate, dimethicone copolyol methyl ether, dimethiconecopolyol phosphate, and dimethicone copolyol stearate. SeeInternational Cosmetic Ingredient Dictionary, Fifth Edition,1993.

Dimethicone copolyol emulsifiers useful herein are described, forexample, in U.S. Pat. No. 4,960,764, to Figueroa, Jr. et al.,issued Oct. 2, 1990; European Patent No. EP 330,369, to Sanogueira,published Aug. 30, 1989; G. H. Dahms, et al., "New FormulationPossibilities Offered by Silicone Copolyols," Cosmetics &Toiletries, vol. 110, pp. 91-100, March 1995; M. E. Carlotti etal., "Optimization of W/O--S Emulsions And Study Of TheQuantitative Relationships Between Ester Structure And EmulsionProperties," J. Dispersion Science And Technology, 13(3), 315-336(1992); P. Hameyer, "Comparative Technological Investigations ofOrganic and Organosilicone Emulsifiers in Cosmetic Water-in-OilEmulsion Preparations," HAPPI 28(4), pp. 88-128 (1991); J.Smid-Korbar et al., "Efficiency and usability of siliconesurfactants in emulsions," Provisional Communication, InternationalJournal of Cosmetic Science, 12, 135-139 (1990); and D. G. Krzysiket al., "A New Silicone Emulsifier For Water-in-Oil Systems," Drugand Cosmetic Industry, vol. 146(4), pp. 28-81 (April 1990).

Among the non-silicone-containing emulsifiers useful herein arevarious non-ionic and anionic emulsifying agents such as sugaresters and polyesters, alkoxylated sugar esters and polyesters,C1-C30 fatty acid esters of C1-C30 fatty alcohols, alkoxylatedderivatives of C1-C30 fatty acid esters of C1-C30 fatty alcohols,alkoxylated ethers of C1-C30 fatty alcohols, polyglyceryl esters ofC1-C30 fatty acids, C1-C30 esters of polyols, C1-C30 ethers ofpolyols, alkyl phosphates, polyoxyalkylene fatty ether phosphates,fatty acid amides, acyl lactylates, soaps, and mixtures thereof.Other suitable emulsifiers are described, for example, inMcCutcheon's, Detergents and Emulsifiers, North American Edition(1986), published by Allured Publishing Corporation; U.S. Pat. No.5,011,681 to Ciotti et al., issued Apr. 30, 1991; U.S. Pat. No.4,421,769 to Dixon et al., issued Dec. 20, 1983; and U.S. Pat. No.3,755,560 to Dickert et al., issued Aug. 28, 1973.

Nonlimiting examples of these non-silicone-containing emulsifiersinclude: polyethylene glycol 20 sorbitan monolaurate (Polysorbate20), polyethylene glycol 5 soya sterol, Steareth-20, Ceteareth-20,PPG-2 methyl glucose ether distearate, Ceteth-10, Polysorbate 80,cetyl phosphate, potassium cetyl phosphate, diethanolamine cetylphosphate, Polysorbate 60, glyceryl stearate, PEG-100 stearate,polyoxyethylene 20 sorbitan trioleate (Polysorbate 85), sorbitanmonolaurate, polyoxyethylene 4 lauryl ether sodium stearate,polyglyceryl-4 isostearate, hexyl laurate, steareth-20,ceteareth-20, PPG-2 methyl glucose ether distearate, ceteth-10,diethanolamine cetyl phosphate, glyceryl stearate, PEG-100stearate, and mixtures thereof.

2) Oil-in-Water Emulsions

Other preferred topical carriers include oil-in-water emulsions,having a continuous aqueous phase and a hydrophobic,water-insoluble phase ("oil phase") dispersed therein. The "oilphase" can contain oil, silicone or mixtures thereof, and includesbut is not limited to the oils and silicones described above in thesection on water-in-silicone emulsions. The distinction of whetherthe emulsion is characterized as an oil-in-water orsilicone-in-water emulsions is a function of whether the oil phaseis composed of primarily oil or silicone. The water phase of theseemulsions consists primarily of water, but can also contain variousother ingredients such as those water phase ingredients listed inthe above section on water-in-silicone emulsion. The preferredoil-in-water emulsions comprises from about 25% to about 98%,preferably from about 65% to about 95%, more preferably from about70% to about 90% water by weight of the total composition.

In addition to a continuous water phase and dispersed oil orsilicone phase, these oil-in-water compositions also comprise anemulsifier to stabilize the emulsion. Emulsifiers useful herein arewell known in the art, and include nonionic, anionic, cationic, andamphoteric emulsifiers. Non-limiting examples of emulsifiers usefulin the oil-in-water emulsions of this invention are given inMcCutcheon's, Detergents and Emulsifiers, North American Edition(1986), published by Allured Publishing Corporation; U.S. Pat. No.5,011,681; U.S. Pat. No. 4,421,769; and U.S. Pat. No. 3,755,560;these references are incorporated herein by reference in theirentirety

Composition Forms

The topical compositions of the subject invention, including butnot limited to lotions, milks, mousses, serums, sprays, aerosols,foams, sticks, pencils, gels, creams and ointments, may comprise adermatologically acceptable emollient. Such compositions preferablycontain from about 2% to about 50% of the emollient. As usedherein, "emollient" refers to a material useful for the preventionor relief of dryness, as well as for the protection of the skin. Awide variety of suitable emollients are known and may be usedherein. Sagarin, Cosmetics, Science and Technology, 2nd Edition,Vol. 1, pp. 32-43 (1972), incorporated herein by reference,contains numerous examples of materials suitable as an emollient. Apreferred emollient is glycerin. Glycerin is preferably used in anamount of from about 0.001 to about 20%, more preferably from about0.01 to about 15%, and most preferably from about 0.1 to about10%.

Ointments of the present invention may comprise a simple carrierbase of animal or vegetable oils or semi-solid hydrocarbons(oleaginous); absorption ointment bases which absorb water to formemulsions; or water soluble carriers, e.g., a water solublesolution carrier. Ointments may further comprise a thickeningagent, such as described in Sagarin, Cosmetics, Science andTechnology, 2nd Edition, Vol. 1, pp. 72-73 (1972), incorporatedherein by reference, and/or an emollient.

Compositions of this invention useful for cleansing ("cleansers")are formulated with a suitable carrier, e.g., as described above,and from about 1% to about 90% of a dermatologically acceptablesurfactant.

The physical form of the cleansing compositions is not critical.The compositions can be, for example, formulated as toilet bars,liquids, shampoos, bath gels, hair conditioners, hair tonics,pastes, or mousses. Toilet bars are most preferred since this isthe form of cleansing agent most commonly used to wash the skin.Rinse-off cleansing compositions, such as shampoos, require adelivery system adequate to deposit sufficient levels of actives onthe skin and scalp. A preferred delivery system involves the use ofinsoluble complexes. For a more complete disclosure of suchdelivery systems, see U.S. Pat. No. 4,835,148, Barford et al.,issued May 30, 1989.

The compositions of the present invention may also be in the formof cosmetics. Suitable cosmetic forms include, but are not limitedto, foundations, lipsticks, rouges, mascaras, and the like. Suchcosmetic products may include conventional ingredients such asoils, colorants, pigments, emollients, fragrances, waxes,stabilizers, and the like. Exemplary carriers and such otheringredients which are suitable for use herein are described, forexample, in copending patent application Ser. No. 08/430,961, filedon Apr. 28, 1995 in the names of Marcia L. Canter, Brain D.Barford, and Brian D. Hofrichter.

B. Optional Components

The compositions of the present invention may contain a variety ofother ingredients such as are conventionally used in a givenproduct type provided that they do not unacceptably alter thebenefits of the invention.

In a preferred embodiment, where the composition is to be incontact with human keratinous tissue, the optional componentsshould be suitable for application to keratinous tissue, that is,when incorporated into the composition they are suitable for use incontact with human keratinous tissue without undue toxicity,incompatibility, instability, allergic response, and the likewithin the scope of sound medical judgment. The CTFA CosmeticIngredient Handbook, Second Edition (1992) describes a wide varietyof nonlimiting cosmetic and pharmaceutical ingredients commonlyused in the skin care industry, which are suitable for use in thecompositions of the present invention. Examples of these ingredientclasses include: abrasives, absorbents, aesthetic components suchas fragrances, pigments, colorings/colorants, essential oils, skinsensates, astringents, etc. (e.g., clove oil, menthol, camphor,eucalyptus oil, eugenol, menthyl lactate, witch hazel distillate),anti-acne agents, anti-caking agents, antifoaming agents,antimicrobial agents (e.g., iodopropyl butylcarbamate),antioxidants (e.g. BHT, BHA, tocopherol), binders, biologicaladditives, buffering agents, bulking agents, chelating agents,chemical additives, colorants, cosmetic astringents, cosmeticbiocides, denaturants, drug astringents, external analgesics, filmformers or materials, e.g., polymers, for aiding the film-formingproperties and substantivity of the composition (e.g., copolymer ofeicosene and vinyl pyrrolidone), opacifying agents, pH adjusters,propellants, reducing agents, sequestrants, skin bleaching andlightening agents (e.g., hydroquinone, kojic acid, ascorbic acid,magnesium ascorbyl phosphate, ascorbyl glucosamine, pyridoxine),skin-conditioning agents (e.g., humectants, including miscellaneousand occlusive), skin soothing and/or healing agents (e.g.,panthenol and derivatives such as ethyl panthenol, aloe vera,pantothenic acid and its derivatives, allantoin, bisabolol, anddipotassium glycyrrhizinate), skin treating agents (e.g., vitamin Dcompounds, mono-, di-, and tri-terpenoids, beta-ionol, cedrol),thickeners, and vitamins and vitamin derivatives.

In any embodiment of the present invention, however, the activesuseful herein can be categorized by the benefit they provide or bytheir postulated mode of action. However, it is to be understoodthat the actives useful herein can in some instances provide morethan one benefit or operate via more than one mode of action.Therefore, classifications herein are made for the sake ofconvenience and are not intended to limit the active to thatparticular application or applications listed.

1) Desquamation Actives

A safe and effective amount of a desquamation active may be addedto the compositions of the present invention, preferably from about0.1% to about 10%, more preferably from about 0.2% to about 5%,even more preferably from about 0.5% to about 4%, by weight of thecomposition. Desquamation actives enhance the skin appearancebenefits of the present invention. For example, the desquamationactives tend to improve the texture of the skin (e.g., smoothness).One desquamation system that is suitable for use herein containssulfhydryl compounds and zwitterionic surfactants and is describedin U.S. Pat. No. 5,681,852, to Bissett, incorporated herein byreference. Another desquamation system that is suitable for useherein contains salicylic acid and zwitterionic surfactants and isdescribed in U.S. Pat. No. 5,652,228 to Bissett, incorporatedherein by reference. Zwitterionic surfactants such as described inthese applications are also useful as desquamatory agents herein,with cetyl betaine being particularly preferred.

2) Anti-Acne Actives

The compositions of the present invention may comprise a safe andeffective amount of one or more anti-acne actives. Examples ofuseful anti-acne actives include resorcinol, sulfur, salicylicacid, erythromycin, zinc, etc. Further examples of suitableanti-acne actives are described in further detail in U.S. Pat. No.5,607,980, issued to McAtee et al, on Mar. 4, 1997.

3) Anti-Wrinkle Actives/Anti-Atrophy Actives

The compositions of the present invention may further comprise asafe and effective amount of one or more anti-wrinkle actives oranti-atrophy actives. Exemplary anti-wrinkle/anti-atrophy activessuitable for use in the compositions of the present inventioninclude sulfur-containing D and L amino acids and their derivativesand salts, particularly the N-acetyl derivatives, a preferredexample of which is N-acetyl-L-cysteine; thiols, e.g. ethane thiol;hydroxy acids (e.g., salicylic acid, glycolic acid), keto acids(e.g., pyruvic acid), ascorbic acid (vitamin C), phytic acid,lipoic acid; lysophosphatidic acid, skin peel agents (e.g., phenoland the like), flavonoids (e.g., flavanones, chalcones,isoflavones, flavones, etc.), stilbenes, cinnamates, resveratrol,kinetin, zeatin, dimethylaminoethanol, peptides from naturalsources (e.g., soy peptides), salts of sugar acids (e.g., Mngluconate), terpene alcohols (e.g., farnesol), peptides andretinoids which enhance the keratinous tissue appearance benefitsof the present invention, especially in regulating keratinoustissue condition, e.g., skin condition, and vitamin B compounds(e.g., thiamine (vitamin B1), pantothenic acid (vitamin B5),camitine (vitamin Bt), riboflavin (vitamin B2), cobalamine (vitaminB12), pangamic acid or diisopropylamine dichloroacetate (vitaminB15's), and their derivatives and salts (e.g., HCl salts or calciumsalts)).

a) Retinoids

The compositions of this invention may contain a safe and effectiveamount of a retinoid, such that the resultant composition is safeand effective for regulating keratinous tissue condition,preferably for regulating visible and/or tactile discontinuities inskin, more preferably for regulating signs of skin aging. Thecompositions preferably contain from about 0.001% to about 10%,more preferably from about 0.005% to about 2%, even more preferablyfrom about 0.01% to about 1%, still more preferably from about0.01% to about 0.5%, by weight of the composition, of the retinoid.The optimum concentration used in a composition will depend on thespecific retinoid selected since their potency does varyconsiderably.

As used herein, "retinoid" includes all natural and/or syntheticanalogs of Vitamin A or retinol-like compounds which possess thebiological activity of Vitamin A in the skin as well as thegeometric isomers and stereoisomers of these compounds. Theretinoid is preferably selected from retinol, retinol esters (e.g.,C.sub.2-C.sub.22 alkyl esters of retinol, including retinylpalmitate, retinyl acetate, retinyl propionate), retinal, and/orretinoic acid (including all-trans retinoic acid and/or13-cis-retinoic acid), or mixtures thereof. More preferably theretinoid is a retinoid other than retinoic acid. These compoundsare well known in the art and are commercially available from anumber of sources, e.g., Sigma Chemical Company (St. Louis, Mo.),and Boerhinger Mannheim (Indianapolis, Ind.). Other retinoids whichare useful herein are described in U.S. Pat. No. 4,677,120, issuedJun. 30, 1987 to Parish et al.; U.S. Pat. No. 4,885,311, issuedDec. 5, 1989 to Parish et al.; U.S. Pat. No. 5,049,584, issued Sep.17, 1991 to Purcell et al.; U.S. Pat. No. 5,124,356, issued Jun.23, 1992 to Purcell et al.; and Reissue 34,075, issued Sep. 22,1992 to Purcell et al. Other suitable retinoids aretocopheryl-retinoate [tocopherol ester of retinoic acid (trans- orcis-), adapalene {6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoicacid}, and tazarotene (ethyl6-[2-(4,4-dimethylthiochroman-6-yl)-ethynyl]nicotinate). Preferredretinoids are retinol, retinyl palmitate, retinyl acetate, retinylpropionate, retinal and combinations thereof. More preferred isretinyl propionate, used most preferably from about 0.1% to about0.3%.

b) Peptides

The compositions of the present invention may contain a safe andeffective amount of a peptide, including but not limited to, di-,tri-, tetra-, and penta-peptides and derivatives. The compositionscontain preferably from about 1.times.10.sup.-6% to about 20%, morepreferably from about 1.times.10.sup.-6% to about 10%, even morepreferably from about 1.times.10.sup.-5% to about 5%, by weight ofthe composition.

As used herein, "peptide" refers to peptides containing ten orfewer amino acids and their derivatives, isomers, and complexeswith other species such as metal ions (e.g., copper, zinc,manganese, magnesium, and the like). As used herein, peptide refersto both naturally occurring and synthesized peptides. Also usefulherein are naturally occurring and commercially availablecompositions that contain peptides. Preferred peptides contain atleast one basic amino acid (e.g., histidine, lysine, arginine).More preferred peptides are the dipeptide camosine (beta-ala-his),the tripeptide gly-his-lys, the tripeptide his-gly-gly, thetripeptide gly-gly-his, the tripeptide gly-his-gly, thepentapeptide lys-thr-thr-lys-ser, and metal complexes of the above,e.g., copper complex of the tripeptide his-gly-gly (also known aslamin). Other suitable peptides include Peptide CK (arg-lys-arg);Peptide CK+ (ac-arg-lys-arg-NH.sub.2); and Peptide E,arg-ser-arg-lys. A preferred commercially available tripeptidederivative-containing composition is Biopeptide CL.RTM., whichcontains 100 ppm of palmitoyl-gly-his-lys and is commerciallyavailable from Sederma, France. A preferred commercially availablepentapeptide derivative-containing composition is Matrixyl.RTM.,which contains 100 ppm of palmitoyl-lys-thr-thr-lys-ser and iscommercially available from Sederma, France. Peptide derivativesuseful herein include lipophilic derivatives, preferably palmitoylderivatives. Preferably, the peptide is selected frompalmitoyl-lys-thr-thr-lys-ser, palmitoyl-gly-his-lys, theirderivatives, and combinations thereof.

c) Hydroxy Acids

The compositions of the present invention may contain a safe andeffective amount of a Hydroxy Acid. Preferred hydroxy acids for usein the compositions of the present invention include alpha hydroxyacids such as lactic acid and glycolic acid. When present in thecompositions of the present invention, the hydroxy acid ispreferably used in an amount of from about 0.01% to about 50%, morepreferably from about 0.1% to about 10%, and still more preferablyfrom about 0.5% to about 2%.

4) Water-Soluble Vitamins

The compositions of the present invention may contain a safe andeffective amount of one or more water-soluble vitamins. Examples ofwater-soluble vitamins include, but are not limited to,water-soluble versions of vitamin B, vitamin B derivatives, vitaminC, vitamin C derivatives, vitamin K, vitamin K derivatives, vitaminD, vitamin D derivatives, vitamin E, vitamin E derivatives, andmixtures thereof. The vitamin compounds may be included as thesubstantially pure material, or as an extract obtained by suitablephysical and/or chemical isolation from natural (e.g., plant)sources. When vitamin compounds are present in the compositions ofthe instant invention, the compositions preferably contain fromabout 0.0001% to about 50%, more preferably from about 0.001% toabout 10%, still more preferably from about 0.01% to about 5%, andstill more preferably from about 1% to about 5%, by weight of thecomposition, of the vitamin compound.

a) Vitamin B.sub.3 Compounds

The compositions of the present invention may contain a safe andeffective amount of a vitamin B.sub.3 compound. When vitaminB.sub.3 compounds are present in the compositions of the instantinvention, the compositions preferably contain from about 0.01% toabout 50%, more preferably from about 0.1% to about 10%, still morepreferably from about 1% to about 10%, and still more preferablyfrom about 2% to about 5%, by weight of the composition, of thevitamin B.sub.3 compound.

As used herein, "vitamin B.sub.3 compound" means a compound havingthe formula:

##STR00004## wherein R is --CONH.sub.2 (i.e., niacinamide), --COOH(i.e., nicotinic acid) or --CH.sub.2OH (i.e., nicotinyl alcohol);derivatives thereof; and salts of any of the foregoing.

Exemplary derivatives of the foregoing vitamin B.sub.3 compoundsinclude nicotinic acid esters, including non-vasodilating esters ofnicotinic acid (e.g., niacinamide), nicotinyl amino acids,nicotinic acid N-oxide and niacinamide N-oxide.

5) Anti-Oxidants/Radical Scavengers

The compositions of the present invention may include a safe andeffective amount of an anti-oxidant/radical scavenger, preferablyfrom about 0.001% to about 10%, more preferably from about 0.01% toabout 5%, of the composition. The anti-oxidant/radical scavenger isespecially useful for providing protection against UV radiationwhich can cause increased scaling or texture changes in the stratumcorneum and against other environmental agents which can cause skindamage.

Anti-oxidants/radical scavengers such as ascorbic acid (vitamin C)and its salts, ascorbic acid derivatives (e.g., magnesium ascorbylphosphate, sodium ascorbyl phosphate, ascorbyl glucoside),tocotrienols, butylated hydroxy benzoic acid salts, butylatedhydroxy benzoic acids and their salts,6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid(commercially available under the tradename Trolox.sup.R), gallicacid and its alkyl esters, especially propyl gallateuric acidsalts, sorbic acid salts, dihydroxy fumaric acid salts, lysine,methionine, proline, superoxide dismutase, silymarin, tea extracts,grape skin/seed extracts, melanin, and rosemary extracts may beused. A preferred anti-oxidants/radical scavenger is vitamin E andderivatives.

6) Anti-Inflammatory Agents

A safe and effective amount of an anti-inflammatory agent may beadded to the compositions of the present invention, preferably fromabout 0.01% to about 10%, more preferably from about 0.1% to about5%, of the composition. The anti-inflammatory agent enhances theskin appearance benefits of the present invention, e.g., suchagents contribute to a more uniform and acceptable skin tone orcolor. The exact amount of anti-inflammatory agent to be used inthe compositions will depend on the particular anti-inflammatoryagent utilized since such agents vary widely in potency.

Steroidal anti-inflammatory agents, including but not limited to,corticosteroids such as hydrocortisone.

A second class of anti-inflammatory agents, which is useful in thecompositions, includes the nonsteroidal anti-inflammatory agents.The varieties of compounds encompassed by this group are well knownto those skilled in the art. For detailed disclosure of thechemical structure, synthesis, side effects, etc. of non-steroidalanti-inflammatory agents, one may refer to standard texts,including Anti-inflammatory and Anti-Rheumatic Drugs, K. D.Rainsford, Vol. I-III, CRC Press, Boca Raton, (1985), andAnti-inflammatory Agents, Chemistry and Pharmacology, 1, R. A.Scherrer, et al., Academic Press, New York (1974). Specificnon-steroidal anti-inflammatory agents useful in the compositioninvention include, but are not limited to, salicylates, flufenamicacid, etofenamate, aspirin, and mixtures thereof.

Finally, so-called "natural" anti-inflammatory agents are useful inmethods of the present invention. Such agents may suitably beobtained as an extract by suitable physical and/or chemicalisolation from natural sources (e.g., plants, fungi, by-products ofmicroorganisms). For example, candelilla wax, alpha-bisabolol, aloevera, Manjistha (extracted from plants in the genus Rubia,particularly Rubia Cordifolia), and Guggal (extracted from plantsin the genus Commiphora, particularly Commiphora Mukul), kolaextract, chamomile, red clover extract, and sea whip extract, maybe used.

Additional anti-inflammatory agents useful herein include allantoinand compounds of the Licorice (the plant genus/species Glycyrrhizaglabra) family, including glycyrrhetic acid, glycyrrhizic acid, andderivatives (e.g., salts and esters). Suitable salts of theforegoing compounds include metal and ammonium salts. Suitableesters include C.sub.2-C.sub.24 saturated or unsaturated esters ofthe acids, preferably C.sub.10-C.sub.24, more preferablyC.sub.16-C.sub.24. Specific examples of the foregoing include oilsoluble licorice extract, the glycyrrhizic and glycyrrhetic acidsthemselves, monoammonium glycyrrhizinate, monopotassiumglycyrrhizinate, dipotassium glycyrrhizinate, 1-beta-glycyrrheticacid, stearyl glycyrrhetinate, and 3-stearyloxy-glycyrrhetinicacid, and disodium 3-succinyloxy-beta-glycyrrhetinate. Stearylglycyrrhetinate is preferred.

7) Flavonoids

The compositions of the present invention may contain a safe andeffective amount of an oil or water-soluble flavonoid. A preferredexample of a water soluble flavonoid is o-glycoside.

Oil-soluble flavonoid compounds are broadly disclosed in U.S. Pat.Nos. 5,686,082 and 5,686,367, both of which are herein incorporatedby reference. Examples of flavonoids suitable for use in thepresent invention are flavanones selected from the group consistingof unsubstituted flavanones, mono-substituted flavanones, andmixtures thereof; chalcones selected from the group consisting ofunsubstituted chalcones, mono-substituted chalcones, di-substitutedchalcones, tri-substituted chalcones, and mixtures thereof;flavones selected from the group consisting of unsubstitutedflavones, mono-substituted flavones, di-substituted flavones, andmixtures thereof; one or more isoflavones; coumarins selected fromthe group consisting of unsubstituted coumarins, mono-substitutedcoumarins, di-substituted coumarins, and mixtures thereof;chromones selected from the group consisting of unsubstitutedchromones, mono-substituted chromones, di-substituted chromones,and mixtures thereof; one or more dicoumarols; one or morechromanones; one or more chromanols; isomers (e.g., cis/transisomers) thereof; and mixtures thereof. By the term "substituted"as used herein means flavonoids wherein one or more hydrogen atomof the flavonoid has been independently replaced with hydroxyl,C1-C8 alkyl, C1-C4 alkoxyl, O-glycoside, and the like or a mixtureof these substituents. Preferred for use herein are flavones andisoflavones, in particular unsubstituted isoflavone, daidzein(7,4'-dihydroxy isoflavone), genistein (5,7,4'-trihydroxyisoflavone), equol (7,4'-dihydroxy isoflavan),5,7-dihydroxy-4'-methoxy isoflavone, soy isoflavones (a mixtureextracted from soy), and mixtures thereof.

They can be synthetic materials or obtained as extracts fromnatural sources (e.g., plants). The naturally sourced material canalso further be derivatized (e.g., an ester or ether derivativeprepared following extraction from a natural source). Flavonoidcompounds useful herein are commercially available from a number ofsources, e.g., Indofine Chemical Company, Inc. (Somerville, N.J.),Steraloids, Inc. (Wilton, N.H.), and Aldrich Chemical Company, Inc.(Milwaukee, Wis.).

Mixtures of the above flavonoid compounds may also be used.

The herein described flavonoid compounds are preferably present inthe instant invention at concentrations of from about 0.01% toabout 20%, more preferably from about 0.1% to about 10%, and mostpreferably from about 0.5% to about 5%.

8) Anti-Cellulite Agents

The compositions of the present invention may contain a safe andeffective amount of an anti-cellulite agent. Suitable agents mayinclude, but are not limited to, xanthine compounds (e.g.,theophylline, theobromine, aminophylline, Genistein, and green tea.Anti-cellulite agents preferably comprise from about 0.1% and toabout 10% by weight of the composition.

9) Tanning Actives

The compositions of the present invention may contain a safe andeffective amount of a tanning active, preferably from about 0.1% toabout 20% of dihydroxyacetone as an artificial tanning active.Dihydroxyacetone, which is also known as DHA or1,3-dihydroxy-2-propanone, is a white to off-white, crystallinepowder.

10) Skin Lightening Agents

The compositions of the present invention may comprise a skinlightening agent. When used, the compositions preferably comprisefrom about 0.1% to about 10%, more preferably from about 0.2% toabout 7.5%, also preferably from about 0.5% to about 5%, by weightof the composition, of a skin lightening agent. Suitable skinlightening agents include those known in the art, including kojicacid, arbutin, tranexamic acid, phytosterols, ascorbic acid andderivatives, e.g., magnesium ascorbyl phosphate or sodium ascorbylphosphate or other salts of ascorbyl phosphate, ascorbyl glucoside,and the like. Other skin lightening materials suitable for useherein include undecylenoyl phenylalanine (Sepiwhite.RTM. fromSEPPIC), aloesin, Actiwhite.RTM. (Cognis), Emblica.RTM. (Rona), andAzeloglicina (Sinerga) and extracts (e.g. mulberry extract,placental extract).

a) Phytosterol

The topical compositions of the present invention comprise a safeand effective amount of one or more phytosterols selected from thegroup consisting of .beta.-sitosterol, campesterol, brassicasterol,.DELTA.5-avennasterol, lupenol, .alpha.-spinasterol, stigmasterol,their derivatives, analogs, and combinations thereof. Morepreferably, the phytosterol is selected from the group consistingof .beta.-sitosterol, campesterol, brassicasterol, stigmasterol,their derivatives, and combinations thereof. Even more preferably,the phytosterol is selected from the group consisting of.beta.-sitosterol, campesterol, brassicasterol, stigmasterol, andcombinations thereof.

Phytosterols can be synthetic or natural in origin and can be usedas essentially pure compounds or mixtures of compounds (e.g.,extracts from natural sources). Phytosterols are generally found inthe unsaponifiable portion of vegetable oils and fats and areavailable as free sterols, acetylated derivatives, sterol esters,ethoxylated or glycosidic derivatives. More preferably, thephytosterols are free sterols. As used herein, "phytosterol"includes isomers and tautomers of such and is commerciallyavailable from Aldrich Chemical Company (Milwaukee, Wis.), SigmaChemical Company (St. Louis, Mo.), and Cognis Corportation. In thecompositions of the present invention, the phytosterol preferablycomprises from about 0.01% to about 10%, by weight of thecomposition, more preferably from about 0.1% to about 7.5%, andmost preferably from about 0.2% to about 5%.

11) Skin Soothing and Skin Healing Actives

A safe and effective amount of a skin soothing or skin healingactive may be added to the present composition, preferably, fromabout 0.1% to about 30%, more preferably from about 0.5% to about20%, still more preferably from about 0.5% to about 10%, by weightof the composition formed. Skin soothing or skin healing activessuitable for use herein include panthenoic acid derivatives(including panthenol, dexpanthenol, ethyl panthenol), aloe vera,allantoin, and dipotassium glycyrrhizinate.

12) Antimicrobial and Antifungal Actives

The compositions of the present invention may comprise anantimicrobial or antifungal active. Such actives are capable ofdestroying microbes, preventing the development of microbes orpreventing the pathogenic action of microbes. A safe and effectiveamount of an antimicrobial or antifungal active may be added to thepresent compositions, preferably, from about 0.001% to about 10%,more preferably from about 0.01% to about 5%, and most preferablyfrom about 0.05% to about 2%.

Examples of antimicrobial and antifungal actives include.beta.-lactam drugs, quinolone drugs, ciprofloxacin, norfloxacin,tetracycline, erythromycin, amikacin, 2,4,4'-trichloro-2'-hydroxydiphenyl ether, 3,4,4'-trichlorobanilide, phenoxyethanol, phenoxypropanol, methyl paraben, ethyl paraben, butyl paraben,Glydant.RTM., Glydant Plus.RTM., phenoxyisopropanol, doxycycline,capreomycin, chlorhexidine, chlortetracycline, oxytetracycline,clindamycin, ethambutol, hexamidine isethionate, metronidazole,pentamidine, gentamicin, kanamycin, lineomycin, methacycline,methenamine, minocycline, neomycin, netilmicin, paromomycin,streptomycin, tobramycin, miconazole, tetracycline hydrochloride,erythromycin, zinc erythromycin, erythromycin estolate,erythromycin stearate, amikacin sulfate, doxycycline hydrochloride,capreomycin sulfate, chlorhexidine gluconate, chlorhexidinehydrochloride, chlortetracycline hydrochloride, oxytetracyclinehydrochloride, clindamycin hydrochloride, ethambutol hydrochloride,metronidazole hydrochloride, pentamidine hydrochloride, gentamicinsulfate, kanamycin sulfate, lineomycin hydrochloride, methacyclinehydrochloride, methenamine hippurate, methenamine mandelate,minocycline hydrochloride, neomycin sulfate, netilmicin sulfate,paromomycin sulfate, streptomycin sulfate, tobramycin sulfate,miconazole hydrochloride, ketaconazole, amanfadine hydrochloride,amanfadine sulfate, octopirox, parachlorometa xylenol, nystatin,tolnaftate, zinc pyrithione and clotrimazole.

Preferred examples of actives useful herein include those selectedfrom the group consisting of methyl paraben, ethyl paraben, butylparaben, Glydant.RTM., Glydant Plus.RTM., salicylic acid, benzoylperoxide, 3-hydroxy benzoic acid, glycolic acid, lactic acid,4-hydroxy benzoic acid, acetyl salicylic acid, 2-hydroxybutanoicacid, 2-hydroxypentanoic acid, 2-hydroxyhexanoic acid, cis-retinoicacid, trans-retinoic acid, retinol, phytic acid,N-acetyl-L-cysteine, lipoic acid, azelaic acid, arachidonic acid,benzoylperoxide, tetracycline, ibuprofen, naproxen, hydrocortisone,acetominophen, resorcinol, phenoxyethanol, phenoxypropanol,phenoxyisopropanol, 2,4,4'-trichloro-2'-hydroxy diphenyl ether,3,4,4'-trichlorocarbanilide, octopirox, lidocaine hydrochloride,clotrimazole, miconazole, ketoconazole, neocycin sulfate, andmixtures thereof

13) Chelators

The compositions of the present invention may also comprise a safeand effective amount of a chelator or chelating agent. As usedherein, "chelator" or "chelating agent" means an active agentcapable of removing a metal ion from a system by forming a complexso that the metal ion cannot readily participate in or catalyzechemical reactions. The inclusion of a chelating agent isespecially useful for providing protection against UV radiationthat can contribute to excessive scaling or skin texture changesand against other environmental agents, which can cause skindamage.

A safe and effective amount of a chelating agent may be added tothe compositions of the subject invention, preferably from about0.1% to about 10%, more preferably from about 1% to about 5%, ofthe composition. Exemplary chelators that are useful herein aredisclosed in U.S. Pat. No. 5,487,884, issued Jan. 30, 1996 toBissett et al.; International Publication No. 91/16035, Bush etal., published Oct. 31, 1995; and International Publication No.91/16034, Bush et al., published Oct. 31, 1995. Preferred chelatorsuseful in compositions of the subject invention are furildioximeand derivatives.

14) Sunscreen Actives

Exposure to ultraviolet light can result in excessive scaling andtexture changes of the stratum corneum. Therefore, the compositionsof the subject invention may optionally contain a sunscreen active.As used herein, "sunscreen active" includes both sunscreen agentsand physical sunblocks. Suitable sunscreen actives may be organicor inorganic.

Non-limiting examples of inorganic sunscreens useful herein includethe following metallic oxides; titanium dioxide having an averageprimary particle size of from about 15 nm to about 100 nm, zincoxide having an average primary particle size of from about 15 nmto about 150 nm, zirconium oxide having an average primary particlesize of from about 15 nm to about 150 nm, iron oxide having anaverage primary particle size of from about 15 nm to about 500 nm,and mixtures thereof. When used herein, the inorganic sunscreensare present in the amount of from about 0.1% to about 20%,preferably from about 0.5% to about 10%, more preferably from about1% to about 5%, by weight of the composition.

A wide variety of conventional sunscreen actives are suitable foruse herein. Sagarin, et al., at Chapter VIII, pages 189 et seq., ofCosmetics Science and Technology (1972), discloses numeroussuitable actives. Specific suitable sunscreen actives include, forexample: p-aminobenzoic acid, its salts and its derivatives (ethyl,isobutyl, glyceryl esters; p-dimethylaminobenzoic acid);anthranilates (i.e., o-amino-benzoates; methyl, menthyl, phenyl,benzyl, phenylethyl, linalyl, terpinyl, and cyclohexenyl esters);salicylates (amyl, phenyl, octyl, benzyl, menthyl, glyceryl, anddi-pro-pyleneglycol esters); cinnamic acid derivatives (menthyl andbenzyl esters, a-phenyl cinnamonitrile; butyl cinnamoyl pyruvate);hydroxy- or methoxy-substituted benzophenones; benzophenones(oxybenzene, sulisobenzone, dioxybenzone, benzoresorcinol,2,2',4,4'-tetrahydroxybenzophenone,2,2'-dihydroxy-4,4'-dimethoxybenzophenone, octabenzone;4-isopropyldibenzoylmethane; butylmethoxydibenzoylmethane;etocrylene; octocrylene; [3-(4'-methylbenzylidene bornan-2-one) and4-isopropyl-di-benzoylmethane.

Of these, 2-ethylhexyl-p-methoxycinnamate (commercially availableas PARSOL MCX), 4,4'-t-butyl methoxydibenzoyl-methane (commerciallyavailable as PARSOL 1789), 2-hydroxy-4-methoxybenzophenone,octyldimethyl-p-aminobenzoic acid,2,2-dihydroxy-4-methoxybenzophenone,ethyl-4-(bis(hydroxy-propyl))aminobenzoate,2-ethylhexyl-2-cyano-3,3-diphenylacrylate, 2-ethylhexyl-salicylate,glyceryl-p-aminobenzoate, 3,3,5-tri-methylcyclohexylsalicylate,methylanthranilate, p-dimethyl-aminobenzoic acid or aminobenzoate,2-ethylhexyl-p-dimethyl-amino-benzoate,2-phenylbenzimidazole-5-sulfonic acid,2-(p-dimethylaminophenyl)-5-sulfonicbenzoxazoic acid, octocrylene,butylmethoxydibenzoylmethane and mixtures of these compounds, arepreferred.

Also useful in the compositions are sunscreen actives having, in asingle molecule, two distinct chromophore moieties which exhibitdifferent ultra-violet radiation absorption spectra. One of thechromophore moieties absorbs predominantly in the UVB radiationrange and the other absorbs strongly in the UVA radiationrange.

Especially preferred sunscreen actives include4,4'-t-butylmethoxydibenzoylmethane,2-ethylhexyl-p-methoxycinnamate, phenyl benzimidazole sulfonicacid, 2-ethylhexyl Salicylate, octocrylene, zinc oxide, andtitanium dioxide, and mixtures thereof.

When present in the composition, a safe and effective amount of thesunscreen active is used, typically from about 1% to about 25%,more typically from about 2% to about 25% by weight of thecomposition. Exact amounts will vary depending upon the sunscreenchosen and the desired Sun Protection Factor (SPF).

15) Particulate Material

The compositions of the present invention may, in some embodiments,contain one or more particulate materials. Nonlimiting examples ofparticulate materials useful in the present invention includecolored and uncolored pigments, interference pigments, inorganicpowders, organic powders, composite powders, optical brightenerparticles, and combinations thereof. These particulates can beplatelet shaped, spherical, elongated or needle-shaped, orirregularly shaped, surface coated or uncoated, porous ornon-porous, charged or uncharged, and can be added to the currentcompositions as a powder or as a pre-dispersion. These particulatematerials may provide a wide range of functions, including by notlimited to modifying skin feel, masking the appearance of certainskin characteristics such as blotchy areas, age spots, freckles,fine lines, wrinkles, and pores, absorbing excess skin sebum/oils,reducing skin shine, improving application properties of thecomposition, masking the color of other components of thecomposition, filling in skin pores, lines and wrinkles, andreducing migration of liquid materials on the skin. Preferably,particulate materials are present in the composition in levels offrom about 0.01% to about 20%, more preferably from about 0.05% toabout 10%, still more preferably from about 0.1% to about 5%, byweight of the composition. There are no specific limitations as tothe pigment, colorant or filler powders used in thecomposition.

Particulate materials useful herein include but are not limited tobismuth oxychloride, sericite, mica, mica treated with bariumsulfate or other materials, zeolite, kaolin, silica, boron nitride,lauroyl lysine, nylon, polyethylene, talc, styrene, polypropylene,polystyrene, ethylene/acrylic acid copolymer, sericite, aluminumoxide, silicone resin, barium sulfate, calcium carbonate, celluloseacetate, PTFE, polymethyl methacrylate, starch, modified starchessuch as aluminun starch octenyl succinate, silk, glass, andmixtures thereof. Preferred organic powders/fillers include, butare not limited, to polymeric particles chosen from themethylsilsesquioxane resin microspheres such as for example thosesold by Toshiba silicone under the name Tospearl 145A; microspheresof polymethylmethacrylates such as those sold by Seppic under thename Micropearl M 100; the spherical particles of crosslinkedpolydimethylsiloxanes, especially such as those sold by Dow CorningToray Silicone under the name Trefil E 506C or Trefil E 505C,sphericle particles of polyamide and more specifically Nylon 12,especially such as those sold by Atochem under the name Orgasol2002D Nat C05, polystyerene microspheres such as for example thosesold by Dyno Particles under the name Dynospheres, ethyleneacrylate copolymer sold by Kobo under the name FloBead EA209, PTFE,polypropylene, aluminium starch ocetenylsuccinate such as thosesold by National Starch under the name Dry Flo, microspheres ofpolyethylene such as those sold by Equistar under the name ofMicrothene FN510-00, silicone resin, polymethylsilsesquioxanesilicone polymer, platelet shaped powder made from L-lauroyllysine, and mixtures thereof. Especially preferred are sphericalpowders with an average primary particle size from 0.1 to 75microns, preferably from 0.2 to 30 microns.

Also useful herein are interference pigments. Interferencepigments, for purposes of the present specification are defined asthin platelike layered particles having a two or more layers ofcontrolled thickness with different refractive indices that yield acharacteristic reflected color from the interference of typicallytwo, but occasionally, more, light reflections, form differentlayers of the platelike particle. The most common examples ofinterference pigments are micas layered with about 50-300 nm filmsof TiO2, Fe2O3, silica, tin oxide, and/or Cr2O3. Such pigments areoften peralescent. Pearl pigments reflect, refract and transmitlight because of the transparency of pigment particles and thelarge difference in the refractive index of mica platelets and, forexample, the titanium dioxide coating. Useful intereferencepigments are available commercially from a wide variety ofsuppliers, for example, Rona (Timiron.TM. and Dichrona.TM.),Presperse (Flonac.TM.), Englehard (Duochrome.TM.), Kobo (SK45-R andSK-45-G), BASF (Sicopearls) and Eckart (e.g. Prestige Silk Red).Especially preferred are interference pigments with smallerparticle sizes, with an average diameter of individual particlesless than about 75 microns in the longest direction, preferablywith an average diameter less than about 50 microns.

Other pigments useful in the present invention provide colorprimarily through selective absorption of specific wavelengths ofvisible light, and include inorganic pigments, organic pigments andcombinations thereof. Examples of useful inorganic pigments includeiron oxides, ferric ammonium ferrocyanide, manganese violet,ultramarine blue, and Chrome oxide. Organic pigments can includenatural colorants and synthetic monomeric and polymeric colorants.An example is phthalocyanine blue and green pigment. Also usefulare lakes, primary FD&C or D&C lakes and blends thereof.Also useful are encapsulated soluble or insoluble dyes and othercolorants. Inorganic white or uncolored pigments useful in thepresent invention, for example TiO2, ZnO, or ZrO2, are commerciallyavailable from a number of sources. One example of a suitableparticulate material contains the material available from U.S.Cosmetics (TRONOX TiO2 series, SAT-T CR837, a rutile TiO2).Particularly preferred are charged dispersions of titanium dioxide,as are disclosed in U.S. Pat. No. 5,997,887, to Ha, et al.,incorporated herein by reference.

Preferred colored or uncolored non-interference-type pigments havea primary average particle size of from about 10 nm to about100,000 nm, more preferably from about 20 nm to about 5,000 nm,most preferably from about 20 nm to about 1000 nm. Mixtures of thesame or different pigment/powder having different particle sizesare also useful herein (e.g., incorporating a TiO2 having a primaryparticle size of from about 100 nm to about 400 nm with a TiO2having a primary particle size of from about 10 nm to about 50nm).

The pigments/powders of the current invention can be surfacetreated to provide added stability of color and/or for ease offormulation. Non-limiting examples of suitable coating materialsinclude silicones, lecithin, amino acids, metal soaps, polyethyleneand collagen. These surface treatments may be hydrophobic orhydrophilic, with hydrophobically treatments being preferred.Particularly useful hydrophobic pigment treatments includepolysiloxane treatments such as those disclosed in U.S. Pat. No.5,143,722, incorporated herein by reference in its entirety.

16) Conditioning Agents

The compositions of the present invention may comprise aconditioning agent selected from the group consisting ofhumectants, moisturizers, or skin conditioners. A variety of thesematerials can be employed and each can be present at a level offrom about 0.01% to about 40%, more preferably from about 0.1% toabout 30%, and most preferably from about 0.5% to about 15%, byweight of the composition. Non-limiting examples of conditioningagents include guanidine; urea; glycolic acid and glycolate salts(e.g. ammonium and quaternary alkyl ammonium); salicylic acid;lactic acid and lactate salts (e.g., ammonium and quaternary alkylammonium); aloe vera in any of its variety of forms (e.g., aloevera gel); polyhydroxy alcohols such as sorbitol, mannitol,xylitol, erythritol, glycerol, hexanetriol, butanetriol, propyleneglycol, butylene glycol, hexylene glycol and the like; polyethyleneglycols; sugars (e.g., melibiose) and starches; sugar and starchderivatives (e.g., alkoxylated glucose, fucose, glucosamine);hyaluronic acid; lactamide monoethanolamine; acetamidemonoethanolamine; panthenol; allantoin; and mixtures thereof. Alsouseful herein are the propoxylated glycerols described in U.S. Pat.No. 4,976,953, to Orr et al, issued Dec. 11, 1990, incorporatedherein by reference.

Also useful are various C.sub.1-C.sub.30 monoesters and polyestersof sugars and related materials. These esters are derived from asugar or polyol moiety and one or more carboxylic acid moieties.Such ester materials are further described in, U.S. Pat. No.2,831,854, U.S. Pat. No. 4,005,196, to Jandacek, issued Jan. 25,1977; U.S. Pat. No. 4,005,195, to Jandacek, issued Jan. 25, 1977,U.S. Pat. No. 5,306,516, to Letton et al, issued Apr. 26, 1994;U.S. Pat. No. No. 5,306,515, to Letton et al, issued Apr. 26, 1994;U.S. Pat. No. 5,305,514, to Letton et al, issued Apr. 26, 1994;U.S. Pat. No. 4,797,300, to Jandacek et al, issued Jan. 10, 1989;U.S. Pat. No. 3,963,699, to Rizzi et al, issued Jun. 15, 1976; U.S.Pat. No. 4,518,772, to Volpenhein, issued May 21, 1985; and U.S.Pat. No. 4,517,360, to Volpenhein, issued May 21, 1985.

Preferably, the conditioning agent is selected from the groupconsisting of urea, guanidine, sucrose polyester, panthenol,allantoin, and combinations thereof.

Thickening Agent (Including Thickeners and Gelling Agents)

The compositions of the present invention can comprise one or morethickening agents, preferably from about 0.1% to about 10%, morepreferably from about 0.1% to about 5%, and most preferably fromabout 0.25% to about 4%, by weight of the composition. Thecompositions of the present invention may also contain mixtures ofthickening agents.

Nonlimiting classes of thickening agents include those selectedfrom the group consisting of:

a) Carboxylic Acid Polymers

Non-limiting examples of commercially available carboxylic acidpolymers useful herein include the carbomers, which arehomopolymers of acrylic acid crosslinked with allyl ethers ofsucrose or pentaerytritol. The carbomers are available as theCarbopol.RTM. 900 series from B.F. Goodrich (e.g., Carbopol.RTM.954). In addition, other suitable carboxylic acid polymeric agentsinclude copolymers of C.sub.10-30 alkyl acrylates with one or moremonomers of acrylic acid, methacrylic acid, or one of their shortchain (i.e., C.sub.1-4 alcohol) esters, wherein the crosslinkingagent is an allyl ether of sucrose or pentaerytritol. Thesecopolymers are known as acrylates/C.sub.10-30 alkyl acrylatecrosspolymers and are commercially available as Carbopol.RTM. 1342,Carbopol.RTM. 1382, Pemulen TR-1, and Pemulen TR-2, from B.F.Goodrich

b) Crosslinked Polyacrylate Polymers

Non-limiting examples of useful crosslinked nonionic polyacrylatepolymers and crosslinked cationic polyacrylate polymers are thosedescribed in U.S. Pat. No. 5,100,660, to Hawe et al, issued Mar.31, 1992; U.S. Pat. No. 4,849,484, to Heard, issued Jul. 18, 1989;U.S. Pat. No. 4,835,206, to Farrar et al, issued May 30, 1989; U.S.Pat. No. 4,628,078 to Glover et al issued Dec. 9, 1986; U.S. Pat.No. 4,599,379 to Flesher et al issued Jul. 8, 1986; and EP 228,868,to Farrar et al, published Jul. 15, 1987, all of which areincorporated herein.

c) Polyacrylamide Polymers

A non-limiting example of a polyacrylamide nonionic polymer usefulherein is one given the CTFA designation polyacrylamide andisoparaffin and laureth-7, available under the Tradename Sepigel305 from Seppic Corporation (Fairfield, N.J.).

Other polyacrylamide polymers useful herein include multi-blockcopolymers of acrylamides and substituted acrylamides with acrylicacids and substituted acrylic acids. Commercially availableexamples of these multi-block copolymers include Hypan SR150H,SS500V, SS500W, SSSA100H, from Lipo Chemicals, Inc., (Patterson,N.J.).

d) Polysaccharides

Nonlimiting examples of polysaccharide gelling agents include thoseselected from the group consisting of cellulose, carboxymethylhydroxyethylcellulose, cellulose acetate propionate carboxylate,hydroxyethylcellulose, hydroxyethyl ethylcellulose,hydroxypropylcellulose, hydroxypropyl methylcellulose, methylhydroxyethylcellulose, microcrystalline cellulose, sodium cellulosesulfate, and mixtures thereof. Also useful herein are the alkylsubstituted celluloses. In these polymers, the hydroxy groups ofthe cellulose polymer is hydroxyalkylated (preferablyhydroxyethylated or hydroxypropylated) to form a hydroxyalkylatedcellulose which is then further modified with a C.sub.10-C.sub.30straight chain or branched chain alkyl group through an etherlinkage. Typically these polymers are ethers of C.sub.10-C.sub.30straight or branched chain alcohols with hydroxyalkylcelluloses.Examples of alkyl groups useful herein include those selected fromthe group consisting of stearyl, isostearyl, lauryl, myristyl,cetyl, isocetyl, cocoyl (i.e. alkyl groups derived from thealcohols of coconut oil), palmityl, oleyl, linoleyl, linolenyl,ricinoleyl, behenyl, and mixtures thereof. Preferred among thealkyl hydroxyalkyl cellulose ethers is the material given the CTFAdesignation cetyl hydroxyethylcellulose, which is the ether ofcetyl alcohol and hydroxyethylcellulose. This material is soldunder the tradename Natrosol.RTM. CS Plus from Aqualon Corporation(Wilmington, Del.).

Other useful polysaccharides include scleroglucans comprising alinear chain of (1-3) linked glucose units with a (1-6) linkedglucose every three units, a commercially available example ofwhich is Clearogel.TM. CS11 from Michel Mercier Products Inc.(Mountainside, N.J.).

e) Gums

Nonlimiting examples of gelling agent gums include materialsselected from the group consisting of acacia, agar, algin, alginicacid, ammonium alginate, amylopectin, calcium alginate, calciumcarrageenan, carnitine, carrageenan, dextrin, gelatin, gellan gum,guar gum, guar hydroxypropyltrimonium chloride, hectorite,hyaluroinic acid, hydrated silica, hydroxypropyl chitosan,hydroxypropyl guar, karaya gum, kelp, locust bean gum, natto gum,potassium alginate, potassium carrageenan, propylene glycolalginate, sclerotium gum, sodium carboyxmethyl dextran, sodiumcarrageenan, tragacanth gum, xanthan gum, and mixtures thereof.

II. Composition Preparation

The compositions of the present invention are generally prepared byconventional methods such as are known in the art of making topicalcompositions. Such methods typically involve mixing of theingredients in one or more steps to a relatively uniform state,with or without heating, cooling, application of vacuum, and thelike. The compositions are preferably prepared such as to optimizestability (physical stability, chemical stability, photostability)and/or delivery of the active materials (e.g., dipalmitoylhydroxyproline, hexamidine, sugar amine). This optimization mayinclude appropriate pH exclusion of materials that can complex withthe active agent and thus negatively impact stability or delivery(e.g., exclusion of contaminating iron), use of approaches toprevent complex formation (e.g., appropriate dispersing agents ordual compartment packaging), use of appropriate photostabilityapproaches (e.g., incorporation of sunscreen/sunblock, use ofopaque packaging or other similarly suitable packaging).

Appropriate pH values are dependent upon the stability requirementsof the specific compositions used. However, most of the instantskin care compositions will have pH values between 4 and 8.

It has also been discovered that when incorporating the dialkanoylhydroxyproline compounds in the water portion of the composition,it is advantageous to use the corresponding salt of said dialkanoylhydroxyproline. This salt form of dialkanoyl hydroxyprolinecompounds could be purchased or made during processing of thecomposition of the present invention. If doing the later, this canbe achieve by a separate salt forming step or make the salt in situwhile processing the composition of the present invention. Eitherway, this is achieved by adding a sufficient amount of a basicreagent at a concentration necessary to convert a desired amount ofthe compound into its corresponding salt that readily issolubilized by water.

III. Methods for Regulating Keratinous Tissue Condition

The compositions of the present invention are useful for regulatinga number of mammalian keratinous tissue conditions. Such regulationof keratinous tissue conditions includes prophylactic andtherapeutic regulation. More specifically, such regulating methodsare directed to, but are not limited to, thickening keratinoustissue (i.e., building the epidermis and/or dermis and/orsubcutaneous layers of the skin and where applicable the keratinouslayers of the nail and hair shaft), preventing, retarding, and/ortreating atrophy of mammalian skin, softening and/or smoothinglips, hair and nails of a mammal, preventing, retarding, and/ortreating itch of mammalian skin, preventing, retarding, and/ortreating the appearance of dark under-eye circles and/or puffyeyes, preventing, retarding, and/or treating sallowness ofmammalian skin, preventing, retarding, and/or treating sagging(i.e., glycation) of mammalian skin, preventing and/or retardingtanning of mammalian skin, desquamating, exfoliating, and/orincreasing turnover in mammalian skin, reducing the size of poresin mammalian skin, regulating oily/shiny appearance of mammalianskin, preventing, retarding, and/or treating hyperpigmentation suchas post-inflammatory hyperpigmentation, preventing, retarding,and/or treating the appearance of spider vessels and/or redblotchiness on mammalian skin, preventing, retarding, and/ortreating fine lines and wrinkles of mammalian skin, preventing,retarding, and/or treating skin dryness (i.e., roughness, scaling,flaking) and preventing, retarding, and/or treating the appearanceof cellulite in mammalian skin.

Applicants have surprisingly found that compositions consistingessentially of the select compounds and combinations of compoundsof the present invention are useful for the above disclosed methodsas well.

Regulating keratinous tissue condition involves topically applyingto the keratinous tissue a safe and effective amount of acomposition of the present invention. The amount of the compositionthat is applied, the frequency of application and the period of usewill vary widely depending upon the level of dipalmitoylhydroxyproline and other components of a given composition and thelevel of regulation desired, e.g., in light of the level ofkeratinous tissue damage present or expected to occur.

In a preferred embodiment, the composition is chronically appliedto the skin. By "chronic topical application" is meant continuedtopical application of the composition over an extended periodduring the subject's lifetime, preferably for a period of at leastabout one week, more preferably for a period of at least about onemonth, even more preferably for at least about three months, evenmore preferably for at least about six months, and more preferablystill for at least about one year. While benefits are obtainableafter various maximum periods of use (e.g., five, ten or twentyyears), it is preferred that chronic applications continuethroughout the subject's lifetime. Typically applications would beon the order of about once per day over such extended periods,however application rates can vary from about once per week up toabout three times per day or more.

A wide range of quantities of the compositions of the presentinvention can be employed to provide a skin appearance and/or feelbenefit. Quantities of the present compositions, which aretypically applied per application, are, in mg composition/cm.sup.2skin, from about 0.1 mg/cm.sup.2 to about 20 mg/cm.sup.2. Aparticularly useful application amount is about 0.5 mg/cm.sup.2 toabout 10 mg/cm.sup.2.

Regulating keratinous tissue condition is preferably practiced byapplying a composition in the form of a skin lotion, clear lotion,milky lotion, cream, gel, foam, ointment, paste, emulsion, spray,conditioner, tonic, cosmetic, lipstick, foundation, nail polish,after-shave, mousse, liquid solution, serum, or the like which isintended to be left on the skin or other keratinous tissue for someesthetic, prophylactic, therapeutic or other benefit (i.e., a"leave-on" composition). After applying the composition to thekeratinous tissue (e.g., skin), it is preferably left on for aperiod of at least about 15 minutes, more preferably at least about30 minutes, even more preferably at least about 1 hour, mostpreferably for at least several hours, e.g., up to about 12 hours.Any part of the external portion of the face, hair, and/or nailscan be treated, e.g., face, lips, under-eye area, eyelids, scalp,neck, torso, arms, hands, legs, fingernails, toenails, scalp hair,eyelashes, eyebrows, etc. The application of the presentcompositions may be done using, e.g., the palms of the hands and/orfingers, an implement, e.g., a cotton ball, swab, pad etc.

Another approach to ensure a continuous exposure of the keratinoustissue to at least a minimum level of the combined actives is toapply the compound by use of a patch applied, e.g., to the face.Such an approach is particularly useful for problem skin areasneeding more intensive treatment (e.g., facial crows feet area,frown lines, under eye area, and the like). The patch can beocclusive, semi-occlusive or non-occlusive. The combinationcomposition can be contained within the patch or be applied to theskin prior to application of the patch. The patch can also includeadditional actives such as chemical initiators for exothermicreactions such as those described in PCT application WO 9701313 toBurkett et al. The patch can also contain a source of electricalenergy (e.g., a battery) to, for example, increase delivery of theactive agents. The patch is preferably left on the keratinoustissue for a period of at least about 5 minutes, more preferably atleast about 15 minutes, more preferably still at least about 30minutes, even more preferably at least about 1 hour, mostpreferably at night as a form of night therapy.

EXAMPLES

The following examples further describe and demonstrate embodimentswithin the scope of the present invention. The examples are givensolely for the purpose of illustration and are not to be construedas limitations of the present invention, as many variations thereofare possible without departing from the spirit and scope of theinvention.

Examples 1-5

Moisturizing oil-in-water lotions/creams are prepared byconventional methods from the following components:

TABLE-US-00001 Example 1 Example 2 Example 3 Example 4 Example 5Water Phase: Water qs qs qs qs qs Glycerin 3 5 7 10 15 DisodiumEDTA 0.1 0.1 0.05 0.1 0.1 Methylparaben 0.1 0.1 0.1 0.1 0.1Niacinamide 2 0.5 3.5 3 5 D-panthenol 0.5 0.1 1.0 0.5 1.5 SodiumHydroxide 0.001 0.002 0.001 0.001 0.001 Benzyl alcohol 0.25 0.250.25 0.25 0.25 FD&C Red #40 -- -- -- -- 0.0005 FD&C Yellow#5 -- -- -- -- 0.0010 GLW75CAP-MP (75% -- 0.5 0.5 -- -- aq. TiO2dispersion).sup.1 Hexamidine isethionate 0.1 0.1 -- 0.1 --Palmitoyl-pentapeptide.sup.2 0.0002 -- -- -- 0.0003 N-acetylglucosamine 2 -- 2 -- 5 Oil Phase: Isohexadecane 3 3 3 4 3Isopropyl Isostearate 1 0.5 1.3 1.5 1.3 Sucrose polyester 0.7 --0.7 1 0.7 Dipalmitoylhyroxyproline 1 2 1 0.1 1 Phytosterol -- -- --0.5 -- Retinyl propionate -- -- -- 0.1 -- Cetyl alcohol 0.4 0.3 0.40.5 0.4 Stearyl alcohol 0.5 0.35 0.5 0.6 0.5 Behenyl alcohol 0.40.3 0.4 0.5 0.4 PEG-100 stearate 0.1 0.1 0.1 0.2 0.1 Stearic Acid0.1 0.05 0.1 0.2 0.1 Cetearyl glucoside 0.1 0.1 0.1 0.25 0.1Thickener: Polyacrylamide/C13-14 1.5 -- 2 2.5 2isoparaffin/laureth-7 Sodium acrylate/sodium -- 3 -- -- --acryloyldimethyl taurate copolymer/isohexadecane/ polysorbate 80Additional Ingredients: Dimethicone/dimethiconol -- 1 2 0.5 2Fragrance -- 0.1 0.1 0.1 0.1 Ursolisomes.sup.3 3 -- -- 1 --Polymethylsilsequioxane -- -- 0.25 -- 1 Nylon-12 -- 0.5 -- -- --Prestige Silk Violet.sup.4 -- -- -- -- 1 Timiron Splendid Red.sup.5-- 1.0 -- 2 -- Total: 100% 100% 100% 100% 100% .sup.1Available fromKobo products.sup.2Palmitoyl-lysine-threonine-threonine-lysine-serine availablefrom Sederma .sup.3Ursolisomes are ursolic acid-containingliposomes available from Coletica .sup.4Titanium dioxide coatedmica violet interference pigment available from Eckart .sup.5Silicaand titanium dioxide coated mica red interference pigment availablefrom Rona

In a suitable vessel, combine the water phase ingredients and heatto 75.degree. C. In a separate suitable vessel, combine the oilphase ingredients and heat to 75.degree. C. Add the oil phase tothe water phase and the resulting emulsion is milled (eg., with aTekmar T-25). Add the thickener to the emulsion. Cool the emulsionto 45.degree. C. while stirring. Upon the mixture cooling to45.degree. C., add the remaining ingredients. Cool the product withstirring to 30.degree. C. and pour into suitable containers.

Examples 6-11

Moisturizing water-in-silicone creams/lotions are prepared byconventional methods from the following components:

TABLE-US-00002 Example Example Example 6 Example 7 Example 8Example 9 10 11 Water Phase: Water qs qs qs qs qs qs Glycerin 3 5 710 15 10 Disodium EDTA 0.1 0.1 0.05 0.1 0.1 0.1 Niacinamide 2 0.53.5 3 5 3 D-panthenol 0.5 0.1 1.0 0.5 1.5 0.5 FD&C Red #40 ---- -- -- 0.0010 -- FD&C Yellow #5 -- -- -- -- 0.0005 --GLW75CAP-MP -- 0.4 -- -- -- -- (75% aq. TiO2 dispersion).sup.1Hexamidine 0.1 0.1 -- 1.0 -- -- isethionate Palmitoyl- -- -- -- --0.0003 -- pentapeptide.sup.2 N-acetyl 2 -- 2 -- 5 -- glucosamineSilicone/Oil Phase: Cyclomethicone 10 5 5 10 7.5 10 D5 Dow Corning-- 10 5 5 7.5 5 9040 silicone elastomer.sup.3 KSG-15AP 5 -- 5 5 7.55 silicone Elastomer.sup.4 Dimethione/dimethiconol -- 2 2 1 2 1Dimethicone 50 1 -- -- -- -- -- csk Phytosterol -- -- -- 0.1 -- 0.1Vitamin E Acetate -- 0.5 0.1 0.1 -- 0.1 Thickener:Polyacrylamide/C13-14 2.5 2.5 -- -- 3 isoparaffin/laureth-7 Sodium-- -- -- 3 -- -- acrylate/sodium acryloyldimethyl tauratecopolymer/isohexadecane/ polysorbate 80 Acrylates/C10-30 -- -- 0.6-- 0.5 -- alkyl acrylates crosspolymer Dipalmitoyl Hydroxy- ProlinePremix: Water 8.8 17.5 8.85 4.4 8.8 4.4 Triethanolamine 0.2 0.50.15 0.1 0.2 0.1 Dipalmitoylhyroxy 1 1 1 0.5 2 1.0 prolineAdditional Ingredients: Fragrance -- 0.1 0.1 0.1 0.1 0.1Triethanolamine -- -- -- -- 0.6 -- Ursolisomes.sup.5 -- -- -- 1 ---- PTFE -- 0.5 -- -- -- -- Polymethylsilsequioxane -- 0.5 1.0 -- ---- Polyethylene -- 0.5 -- -- 1.0 -- Flamenco Summit -- -- 1.0 -- ---- Green G30D.sup.6 Prestige Silk Red.sup.7 -- -- -- 1.0 1.0 1.0Total: 100% 100% 100% 100% 100% 100% .sup.1GLW75CAP-MP, 75% aqueoustitanium dioxide dispersion from Kobo.sup.2Palmitoyl-lysine-threonine-threonine-lysine-serine availablefrom Sederma .sup.3A silicone elastomer dispersion from Dow CorningCorp .sup.4A silicone elastomer dispersion from Shin Etsu,.sup.5Ursolisomes are ursolic acid-containing liposomes availablefrom Coletica .sup.6Titanium dioxide and tin oxide coated micagreen interference pigment from Engelhard .sup.7Titanium dioxidecoated mica red interference pigment from Eckart

In a suitable vessel, combine and mix the water phase ingredientsuntil uniform. In a separate suitable container, combine and mixthe silicone/oil phase ingredients until uniform. Separately,prepare the dipalmitoyl hydroxyproline premix by combining thepremix ingredients in a suitable container, heating to about70.degree. C. while stirring, and cooling to room temperature whilestirring. Add half the thickener and then the silicone/oil phase tothe water phase and mill the resulting emulsion (eg., with a TekmarT-25). Add the remainder of the thickener, the dipalmitoylhydroxyproline premix, and then the remaining ingredients to theemulsion while stirring. Once the composition is uniform, pour theproduct into suitable containers.

Examples 12-17

Moisturizing water-in-silicone creams/lotions are prepared byconventional methods from the following components:

TABLE-US-00003 Example Example Example Example Example ExampleComponent 12 13 14 15 16 17 Phase A water qs qs qs qs qs qsallantoin 0.2000 0.2000 0.2000 0.2000 0.2000 0.2000 disodium EDTA0.1000 0.1000 0.1000 0.1000 0.1000 0.1000 ethyl paraben 0.20000.2000 0.2000 0.2000 0.2000 0.2000 propyl paraben 0.1000 0.10000.1000 0.1000 0.1000 0.1000 BHT 0.0150 0.0150 0.015 0.0150 0.01500.015 dexpanthenol 1.0000 0.5000 1.0000 1.0000 1.0000 1.0000glycerin 7.5000 10.0000 15.0000 7.5000 5.0000 15.0000 hexamidine0.2000 0.1000 0 0.5000 1.0000 0 isethionate niacinamide 2.00003.5000 5.0000 2.0000 2.0000 5.0000 palmitoyl- 0 0 0 0.0004 0.0003 0pentapeptide* Phenylbenzimidazole 0 0 0 0 1.0000 0 sulfonic acidbenzyl alcohol 0.2500 0.2500 0.2500 0.2500 0.2500 0.2500triethanolamine 0 0 0 0 0.6000 0 green tea extract 1.0000 1.00001.0000 1.0000 1.0000 1.0000 N-acetyl 5.0000 0 5.0000 5.0000 5.00000 glucosamine sodium 0.1000 0.1000 0.1000 0.1000 0.1000 0.1000metabisulfite Phase B cyclopentasiloxane 15.0000 15.0000 18.000015.0000 15.0000 18.0000 titanium dioxide 0.5000 0.5000 0.75000.5000 0.5000 0.7500 Phase C C12-C15 alkyl 1.5000 0 0 1.5000 1.50000 benzoate vitamin E acetate 0.5000 0 1.0000 0.5000 0.5000 1.0000retinyl propionate 0.3000 0 0 0.2000 0.2000 0 phytosterol 2.0000 00 5.0000 3.0000 0 Phase D KSG-21 silicone 4.0000 4.0000 5.00004.0000 4.0000 5.0000 elastomer.sup.1 Dow Corning 9040 15.000015.0000 12.0000 15.0000 15.0000 12.0000 silicone elastomer.sup.2Abil EM-97 0.5000 0 0 0.5000 0.5000 0 Dimethicone Copolyol.sup.3polymethylsilsesquioxane 2.5000 2.5000 2.0000 2.5000 2.5000 2.0000fragrance 0.2000 0.2000 0.2000 0.2000 0.2000 0.2000 Phase E Water8.8 17.5 8.85 4.4 8.8 8.85 Triethanolamine 0.2 0.5 0.15 0.1 0.20.15 Dipalmitoylhyroxy 1 2 1 0.5 1 1 proline .sup.1KSG-21 is anemulsifying silicone elastomer available from Shin Etsu .sup.2Asilicone elastomer dispersion from Dow Corning Corp .sup.3AbilEM-97 available from Goldschmidt Chemical Corporation

In a suitable vessel, blend the Phase A components together with asuitable mixer (e.g., Tekmar model RW20DZM) and continue mixing todissolve all of the components. Then, blend the Phase B componentstogether in suitable vessel and mill using a suitable mill (e.g.,Tekmar RW-20) for about 5 minutes. Add the Phase C components tothe Phase B mixture with mixing. Then, add the Phase D componentsto the mixture of Phases B and C and then mix the resultingcombination of Phase B, C and D components using a suitable mixer(e.g., Tekmar RW-20) for about 1 hour. Then prepare Phase E is bycombining all ingredients, heating the ingredients to 70.degree. C.while stirring, and cooling back to room temperature whilestirring. Add Phase E to Phase A while mixing. Next, slowly addPhase A is to the mixture of Phases B, C and D with mixing. Mix theresulting mixture is continually until the product is uniform. Thenmill the resulting product for about 5 minutes using an appropriatemill (e.g., Tekmar T-25).

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