USOO6214322B1 (12) United States Patent (10) Patent No.: US 6,214,322 B1 Castro et al. (45) Date of Patent: *Apr. 10, 2001

(54) SELF-TANNING COMPOSITION (56) References Cited COMPRISING CARMINE U.S. PATENT DOCUMENTS (75) Inventors: Mauricio Castro, Rancho Palos Verdes; Frederick W. Woodin, Jr., Pacific 5,318,774 6/1994 Alban et al...... 424/59 s 5,458.872 10/1995 Durnad...... 424/59 Palisades, both of CA (US) 5,620,681 4/1997 Takata et al...... 424/59 5,626,839 5/1997 Scales-Medeiros ...... 424/59 (73) Assignee: Neutrogena Corporation, Los Angeles, 5,662,890 9/1997 Punto et al...... 424/59 CA (US) 5,741,480 4/1998 Ascione ...... 424/59 (*) Notice: Subject to any disclaimer, the term of this OTHER PUBLICATIONS patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days. StreakGuard TM Bain de Soleil Sunless Tanning Creeme This patent is Subject to a terminal dis- Vanishing Tint Deep Dark, photocopy of package 1998. claimer. Primary Examiner. Shelley A. Dodson (21) Appl. No.: 09/333,446 (74) Attorney, Agent, or Firm William E. McGowan (22) Filed: Jun. 15, 1999 (57) ABSTRACT (51) Int. Cl." ...... A61K 7/42; A61K 7/44; The present invention relates to a composition comprising A61K 7/OO Self-tanning agent and carmine, cosmetic products compris (52) U.S. Cl...... 424/59; 424/60; 424/400; ing Such composition and a cosmetically acceptable carrier, 424/401 and methods of using Such products. (58) Field of Search ...... 424/59, 60, 400, 424/401 22 Claims, No Drawings US 6,214,322 B1 1 2 SELF-TANNING COMPOSITION Sifying agents, humectants, fragrances, preservatives, COMPRISING CARMINE Sugars, Sunscreen agents, Surfactants, Suspending agents, thickening agents, and vehicles. FIELD OF THE INVENTION In another aspect, the invention features a method of tanning, coloring, and/or darkening the hair, Skin, or nails of The present invention relates to a Self-tanning composi a Subject (e.g., a human), the method comprising applying to tion containing colorant materials. the same an effective amount of the above-mentioned com BACKGROUND OF THE INVENTION position or product. Other features and advantages of the present invention Because of the risks associated with Sun tanning Such as will be apparent from the detailed description of the inven Sunburn, many people use Self-tanning compositions as a tion and from the claims means to either achieve a tan without exposure to the Sun, obtain a deeper tan with less exposure to the Sun, or to DETAILED DESCRIPTION OF THE extend the natural life of their Suntan. The major consumer INVENTION dissatisfaction relating to Self-tanning compositions relates 15 to the unevenness of skin coloration, an effect not often seen It is believed that one skilled in the art can, based upon the until hours after application of the composition. This result description herein, utilize the present invention to its fullest Stems from the inability to apply even amounts of the Sunless extent. The following Specific embodiments are to be con tanning composition over large areas of skin. Strued as merely illustrative, and not limitative of the Companies have recently added color to the finished remainder of the disclosure in any way whatsoever. Self-tanning compositions to provide a visual aid to the user, Unless defined otherwise, all technical and Scientific thereby, helping to prevent uneven administration on the terms used herein have the same meaning as commonly skin Surface. These colors also provide an immediate dark understood by one of ordinary skill in the art to which the ening effect on the skin. Most of these colorants, however, invention belongs. Also, all publications, patent are nitrogen-based compounds and/or contain metal oxides, 25 applications, patents, and other references mentioned herein e.g., Estee Lauder's Self-action Go Bronze Tinted Self are incorporated by reference. Tanner for Face. Dihydroxyacetone, the active ingredient in The present invention relates to the use of natural colorant most Self-tanning compositions, however, is highly reactive materials to provide an immediate coloration effect to the with metal oxides and many chemical compounds contain skin. The invention relates to the use of carmine, or a blend ing nitrogen. The present invention relates to the use of of carmine with other natural colorants, Such as caramel and colorants in a Self-tanning formulation that are not reactive beta-carotene, where the chemical Structure of the other with the active Self-tanning agent. natural colorant does not contain nitrogen. The colorants, thus, do not react with the active Self-tanning agent (e.g., SUMMARY OF THE INVENTION 1,3-dihydroxyacetone) and provide the manufacturer the In one aspect, the invention features a composition com 35 ability to customize the color of the composition to match prising carmine and a Self-tanning agent. In one various skin tones. The caramel provides a brown tone the embodiment, the composition further comprises caramel. In carmine provides a red tone, and the beta-caroteine provides one embodiment, the ratio between carmine and caramel is a yellow tone. What is meant by Self-tanning agent is a chemical agent between about 1:1 to about 1:100 (e.g., between about 1:5 to 40 1:50 or between about 1:5 to about 1:30). In one capable of producing or inducing the artificial tanning embodiment, the composition comprises between about process of the Skin by forming brown pigments in the skin, 0.001% and about 1% (e.g., between about 0.01% to about e.g., through the Maillard reaction reported in Bobin, et al., 0.2%) of carmine. In one embodiment, the composition J. Soc. Cosmet. Chem., 35:265–72 (1984). Examples of Self-tanning agents include alloxan, methyl glyoxal, comprises between about 0.001% and about 5% (e.g., 45 between about 0.1% to about 2%) of caramel. In another ethoxydiglycol, glyceraldehyde, various indoles and imida embodiment, the Self-tanning agent is Selected from the Zoles and their derivatives, pigmentation agents Such as group consisting of 1,3-dihydroxyacetone and 1,3,4- methoXSelen and trioxSelan, and C-hydroxy ketones and trihydroxy-2-butanone. In another embodiment, the compo aldehydes Such as , e.g., of the formula: Sition further comprises the colorant beta-caroteine. In one 50 embodiment, the ratio between carmine and beta-carotene is between about 10:1 to about 1:10 (e.g., between about 5:1 to 1:5 or between about 2:1 to about 1:2). In one embodiment, the composition comprises between about 0.001% and about OH 1% (e.g., between about 0.01% to about 0.2%) of beta 55 CarOtene. In another aspect, the invention features a cosmetic prod wherein R is H, CHOH, CHOHCHOH, CH(OH)CH uct for application to the hair, Skin, or nails of a Subject for (=O), CH(NH)CH(=O), CH(OCH) CH(=O), or the purpose of tanning, coloring, and/or darkening the same CH(NH-Phenyl)CH(=O); and R is H or CH-OH. An comprising: (a) the above-mentioned composition; and (b) a 60 example of a compound of Such formula is 1,3- cosmetically acceptable carrier. dihydroxyacetone (i.e., dihydroxyacetone) and 1,3,4- In one embodiment, the cosmetically acceptable carrier trihydroxy-2-butanone (i.e., erythrulose). comprises one or more of the members Selected from the In one aspect, the invention features a cosmetic product group consisting of acidifying agents, alkalizing agents, for application to hair, Skin, and nails of a Subject compris aeroSol propellants, antimicrobial agents, antioxidants, buff 65 ing a cosmetically acceptable carrier. The individual com ering agents, chelating agents, coloring additives, dermoto ponents of the carrier are numerous and varied, but are also logically active agents, dispersing agents, emollients, emul well known to one skilled in the art. In one aspect, the carrier US 6,214,322 B1 3 4 comprises one or more of the members Selected from the composition. Examples of chelating agents included edatate group consisting of acidifying agents, alkalizing agents, dipotassium, edetate disodium, edetic acid, and ethylenedi aeroSol propellants, antimicrobial agents, antioxidants, buff amine tetracetic acid (EDTA) and its Salts (e.g., tetrasodium ering agents, chelating agents, coloring additives, dermoto EDTA). Other chelating agents are listed on page 1626 of the logically active agents, dispersing agents, emollients, emul ICT handbook. Sifying agents, humectants, fragrances, preservatives, Coloring additives are used to add color to the composi Sugars, SunScreen agents, Surfactants, Suspending agents, tion in order to help the user identify the area in which the thickening agents, an vehicles. These ingredients are dis composition has been applied and/or modify the tanning cussed below. Examples of these agents are listed below as color produced by the Self-tanning agent in the composition. well as in the International Cosmetic Ingredient Dictionary Examples of Such coloring additives include caramel, and Handbook, eds. Wenninger and McEwen (The carmine, fluorescein derivatives, methoXSalen, trioxSalen, Cosmetic, Toiletry, and Fragrance ASSoc., Washington, D.C., carbon black, azo dyes, anthraquinone dyes, blue azulenes, 7" Edition, 1997) (hereinafter “ICT Handbook”). guajaZulene, chamuZulene, erythrosin, bengal rose, phloxin, When formulating the composition with these ingredients, cyanosin, daphinin, eosin G, cosin 10B, and Acid Red 51. ones containing metal oxides and active nitrogen groups, 15 Other coloring additives are listed on page 1628–30 of the e.g., active amine groups, should be avoided when using ICT handbook. As discussed above, it is preferred not to use reactive self-tanning agents (e.g., dihydroxyacetone). coloring additives which contain nitrogen or metals. Furthermore, agents that interfere with the Maillard reaction Dermatologically active agents include agents for treating should also not be used. wound healing, inflammation, acne, psoriasis, cutaneous Acidifying and alkalizing agents are added to obtain the aging, Skin cancer, impetigo, herpes, chickenpox, dermatitis, desired pH of the composition. Examples of is acidifying pain, itching, and Skin irritation. Examples of Such derma agents included citric acid, lactic acid, glycolic acid, acetic tologically active agents include hydrocortisone, acid, glacial acetic acid, malic acid, and proprionic acid. de Xame the Sone, panthenol, phenol, tetracycline Examples of alkalizing agent include edetol, potassium hydrochloride, yeast, heXylresorcinol, lamin, kinetin, carbonate, potassium hydroxide, Sodium borate, Sodium 25 be tame thaSone, triam cino lone, flu o cino lone, carbonate, Sodium citrate, Sodium lactate, Sodium glycolate, methylprednisolone, retinoids Such as retinol and retinoic and Sodium hydroxide. Other acidifying and alkalizing acid, dapSone, SulfaSalazine, resorcinol, Salicylic acid, ben agents are listed on page 1653 of the ICT handbook. Zoyl peroxide, erythromycin-benzoyl peroxide, AeroSol propellants are used when the composition is to erythromycin, clindamycin, mupirocin, griseofulvin, azoles be administered as an aerosol under pressure. Examples of Such as miconazole, econazole, itraconazole, fluconazole, aeroSol propellants include halogenated hydrocarbons Such and ketoconazole, ciclopiroX, allylamines Such as naftifine as dichlorodifluoromethane, dichlorotetrafluoroethane, and and terfinafine, acyclovir, famciclovir, Valacyclovir, trichloromonfluoromethane, nitrogen, and volatile hydrocar benzocaine, lidocaine, dibucaine, pramoxine hydrochloride, bons Such as butane, propane, isobutane, or mixtures methyl Salicylate, camphor, menthol, resocinol, and Vita thereof. Other aerosol propellants are listed on page 1655 of 35 mins Such as tocopherol, tocopheryl acetate, pantothenic the ICT handbook. acid, panthenol, ascorbic acid, biotin, and retinoids Such as Antimicrobial agents are used when the area that the retinol, retinoic acid, retinal, retinyl acetate, and retinyl composition is to be applied is prone to microbial infection, palmitate, C-hydroxy acid, a B-hydroxy acid, or poly e.g., by bacteria, fungal, or protozoa. Examples of Such hydroxy acid Such as glycolic acid, lactic acid, citric acid, agents include benzyl alcohol, chlorobutanol, phenylethyl 40 malic acid, and azaleic acid alcohol, phenylmercuric acetate, potassium Sorbate, and Examples of dispersing and Suspending agents include Sorbic acid, benzoic acid, butylparaben, ethylparaben, poligeenan, magnesium aluminum Silicate, Xanthum gum, methylparaben, propyl paraben, and Sodium benzoate. Other and Silicon dioxide. Other dispersing or Suspending agents antimicrobial agents are listed on page 1612 of the ICT are listed on page 1612 of the ICT handbook. handbook. 45 Emollients are agents which Soften and Smooth the Skin. Antioxidants are used to protect ingredients of the com Examples of emollients include hydrocarbon oils and waxes position from oxidizing agents that are included within or Such as mineral oil, petrolatum, microcrystaline wax, come in contact with the composition. Examples of antioxi polyethylene, triglyceride esterS Such as those of castor oil, dants include water Soluble antioxidants Such as grape Seed cocoa butter, Safflower oil, cottonseed oil, corn oil, olive oil, extract, camellia oleifera extract, N-acetyl-L-cysteine, 50 cod liver oil, almond oil, avocado oil, palm oil, Sesame oil, ascorbic acid, Sodium Sulfite, Sodium formaldehyde, Squalene, and Soybean oil, acetylated monoglycerides, isoascorbic acid, cysteine hydrochloride, 1,4-diazobicyclo ethoxylated glycerides, fatty acids, alkyl esters of fatty acids, (2,2,2)-octane, and mixtures thereof. Examples of oil alkyl esters of benzoic acid (e.g., benzoates), alkenyl esters Soluble antioxidants include ascorbyl palmitate, butytlated of fatty acids, fatty alcohols, fatty alcohol ethers, ether hydroxyanisole, butylated hydroxytoluene, potassium pro 55 esters, lanolin and derivatives of lanolin, polyhydric alcohol pyl gallate, octyl gallate, dodecyl gallate, phenyl-O-napthyl esters, wax esterS Such as beeswax, vegetable waxes, amine, and tocopherols Such as C-tocopherol. Other anti phospholidds, and Sterols. Other emollients are listed on oxidants are listed on pages 1612-13 of the ICT Handbook. pages 1656-61 of the ICT handbook. Buffering agents are used to maintain an established pH of Emulsifying agents are used for preparing the oil-in-water the composition. Examples of buffering agents included 60 emulsions of the present invention. Examples of emulsifying calcium acetate, potassium metaphosphate, potassium phos agents include Arlacel is "M and methyl gluceth phate monobasic, Sodium citrate, and tataric acid. Other Sesquisterate, fatty alcohols, fatty alcohols and alkyl phenols buffering agents are listed on page 1612 of the ICT hand condensed with ethylene oxide. Other emulsifiers are listed book. on pages 1679-87 of the ICT Handbook. Emulsion stabi Chelating agents are used to maintain the ionic Strength of 65 lizers are listed on pages 1634-35 of the ICT Handbook. the composition and/or bind to destructive compounds and Humectants are agents which promote the retention of metals that are included within or come in contact with the moisture, e.g., moisturizers. Examples of humectants US 6,214,322 B1 S 6 include Sorbitol, glycerin, glycereth 5 lactate, glycereth 7 water), oil-in-water emulsions (e.g., where the continuous triacetate, glycereth 7 diisononoate, hexanetriol, glycols water phase contains the water Soluble agents and the Such as methyl-propanediol, 1,2-pentanediol, heXylene discontinuous oil phase contains the oil Soluble agents), and glycol, and propylene glycol, alkoxylated glucose, water-in-oil emulsions (e.g., where the continuous oil phase D-panthenol and derivatives thereof, and hyaluronic acid. contains the oil Soluble agents and the discontinuous water Other humectants are listed on pages 1661-62 of the ICT phase contains the water Soluble agents). The oil phase may Handbook. be established by the addition of an animal/vegetable Examples of fragrances include peppermint, rose oil, rose derived oil, ester, or ether, a hydrocarbon and/or Silicone water, aloe Vera, clove oil, menthol, camphor, eucalyptus oil, Solvents, e.g., dimethicone and cyclomethicone, together and other plant extracts. Certain fragrances may require a with various emulsifying agents. solubilizer, e.g., PPG-5-ceteth-20. To eliminate certain odors The cosmetically acceptable carrier may be in a number from compositions, masking agents may be used. An of different delivery forms, e.g., a spray, mist, aerosol, example of a masking agent includes ethylene brassylate. Semi-Solid cream, liquid Such as a Solution, emulsion, or Other fragrances and masking agents are listed on pages Suspension, lotion, gel, Solid Such as a powder, adherent 1639–40 of the ICT Handbook. 15 Stick, flexible mask, or Self-hardening liquid or gel, or other Preservatives are used to protect the composition from Suitable forms intended to be applied to the hair, Skin, or degradation. Examples of preservatives include nails of a Subject. Water-in-oil emulsions (e.g., ratio of about phenoxyethanol, benzoic aicd, benzyl alcohol, parabens 10:1 to about 1:100 such as about 1:1 to about 1:10) and Such as methylparaben, propylparaben, butylparaben, oil-in-water emulsions (e.g., ratio of about 10:1 to about isopropylparaben, and isobutylparaben, diazolidinyl urea, 1:100 such as about 1:1 to about 1:10) are typically used in imidazolidinyl urea, diazolindyl urea, benzalkonium preparing lotions and creams. chloride, benzethonium chloride, phenol, and mixtures The Viscosity of the composition or product of the present thereof (e.g., the paraben mixture Liquipar Oil TM). Other invention depends upon the type of formulation being preservatives are listed on pages 1654-55 of the ICT Hand prepared, e.g., a liquid formulation will have a higher book. 25 Viscosity than a cream or gel formulation. Typically, the Sugars are used to improve the results obatined by the Viscosity of cream formulations of the present invention will Self-tanning agents. Examples of Sugars include range from 5,000 to 150,000 cps (e.g., about 10,000 to about monosaccharides, disaccharides, Sorbitol, and polySccha 40,000 cps). Bulking agents may be used to increase the rides Such as glucose, Xylose, fructose, reose, ribose, Viscosity of the composition. An example of a bulking agent pentose, arabinose, allose, tallose, altrose, mannose, is talc, magnesium aluminum Salicate, and Starches. Other galactose, lactose, Sucrose, erythrose, glyceraldehyde, or bulking agents are listed on page 1625-26 of the ICT any combination thereof. Handbook. Other Viscosity increasing agents are listed on SunScreen agents are agents used to Screen or reduce the pages 1693–97 of the ICT Handbook. Viscosity decreasing amount of ultraviolet radiation impinging on the skin (e.g., agents are listed on pages 1692-92 of the ICT Handbook. by absorption, Scattering, and reflection of the ultraViolet 35 The composition or product the present invention may be radiation). Segarin, et al., Cosmetics Science and prepared using methodology that is well known by an artisan Technology, Chapter VIII, pages 189, et Seq. discloses of ordinary skill (e.g., by using well-known mixing and numerous examples of Sunscreen agents. Examples of Sun blending procedures). For examples, for emulsion products Screen agents include both organic compounds and their of the present invention, each phase of the emulsion may be Salts. Such as phenylbenzimidazole Sulfonic aicd, octyl 40 Separately prepared with all of the components contained in methoxycinnamate, octyl Salicylate, benzophenones Such as their appropriate phases. The emulsion is then formed by benzophenone-3, homosalate, octocrylene, avobenzone, and adding one phase to the other phase with agitation. menthyl anthranilate, as well as inorganic particulate mate The composition or product of the present invention may rials. Such as Zinc oxide and titanium dioxide. Other Sun be packaged in a container that is well known by an artisan screen agents are listed on page 1672 of the ICT Handbook. 45 of ordinary skill, e.g., in a polyethylene or PVC tube with a Generally, the composition will contain from about 1% to dispensing cap. about 50%, by weight, of Sunscreen agent(s). The exact The composition of the present invention may be prepared amounts will vary depending on the Sunscreen used and the using methodology that is well known by an artisan of desired sun-protection factor (SPF), e.g., and SPF of at least ordinary skill. The following is a description of the manu 4 or an SPF of at least 15. 50 facture of two compositions/products of the present inven Surfactants are agents used to Stabilize multi-component tion. Other compositions of the invention can be prepared in compositions, e.g., used as Wetting agents, antifoam agents, an analogous manner by a perSon of ordinary skill in the art. emulsifiers, dispersing agents, and penetrants. Examples of Surfactants include alkene oxide, ethers of fatty alcohols, EXAMPLE 1. glucose, and Sorbitol, methyl gluceth 20, decyl 55 polyglucoside, laureth 4, laureth 9, monoethanolamine, non The weight and weight percentage of the ingredients of Oxynol 4, nonoxynol 9, nonoxynol 10, nonoxynol 15, non the oil-in-water emulsion cream of this Example 1 are Oxynol 30, poloxalene, polyoxyl 8, 40, and 50 Stearate, recited below in Table 1. polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, and polysorbate 85, sodium lauryl 60 TABLE 1. Sulfate, Sorbitan and its derivatives. Other Surfactants are INGREDIENTS Weight (%) listed on page 1672-90 of the ICT Handbook. Vehicles are often referred to as the base for the cosmeti Phase A cally acceptable carrier, e.g., a fluid that is capable of WATER 67.04 delivering the other components of the composition to the 65 CARMINE POWDER O.04 skin with acceptable absorption of those components into CARAMEL 0.95 the skin. Examples of vehicles include water (e.g., deionized US 6,214,322 B1 7 8 EXAMPLE 2 TABLE 1-continued The weight and weight percentage of the ingredients of the oil-in-water emulsion cream of this Example 2 are INGREDIENTS Weight (%) recited below in Table 2. XANTHAN GUM OSO MAGNESIUMALUMINUM SILICATE 1.50 TABLE 2 GLYCERN 2.OO METHYL-PROPANEDOL 1.OO INGREDIENTS Weight (%) TETRASODIUM EDTA O.10 SORBITOL (70%) IN WATER 2.OO Phase A CTRIC ACID O.10 Phase B WATER 66.942 XANTHAN GUM OSO CETYLALCOHOL 140 MAGNESIUMALUMINUM SILICATE 1.50 STEARYLALCOHOL O.70 GLYCERN 1.OO OCTYLEHYDROXYSTEARATE BENZOATE 2.OO METHYL-PROPANEDOL 1.OO C12-15 ALKYL BENZOATE 2.OO 15 TETRASODIUM EDTA O.10 METHYL GLUCETH-2O BENZOATE 2.OO SORBITOL 70%. IN WATER 2.OO ARLACEL 165 TM 1.50 Phase B METHYL GLUCETH SESQUISTEARATE O.8O LIOUAPAR OILTM O60 CETYLALCOHOL 140 PHENOXYETHANOL 1.OO STEARYLALCOHOL O.70 METHYLPARABEN O.2O OCTYL HYDROXYSTEARATE BENZOATE 2.OO BHT O.O7 C12-15 ALKYL BENZOATE 2.OO Phase C METHYL GLUCETH-2O BENZOATE 2.OO GLYCERYL STEARATE/PEG1OOSTEARATE 1.50 WATER 8.OO METHYL GLUCETH SESQUISTEARATE O.2O DIHYDROXYACETONE 4.OO PEG2O METHYL GLUCOSE SESQUISTEARATE O60 CTRIC ACID O.OO PHENOXYETHANOL O.80 SODIUM CITRATE O.OO 25 Phase C Phase D BETA-CAROTENE (2%) EMULSION O.32 FRAGRANCE OSO Phase D

1OOOO WATER 1O.OO DIHYDROXYACETONE S.OO CARMINE POWDER O.O45 The Suppliers of the following ingredients are indicated: CARAMEL O.393 Carmine (Warner-Jenkinson, St. Louis, Mo.), Caramel (D.C., Inc., South Plainfield, N.J.), Methyl-propanediol 100.00 (sold as MP Diol Glycol from Lyondell, Newton Square, 35 Pa.), ArlacelesTM (a mixture of glyceryl Stearate and PEG The beta-carotene (2%) emulsion was obtained from 100 Stearate sold by ICI Surfactants, Wilmington, Del.), Warner-Jenkinson, St. Louis, Mo. The ingredients of Phase Octyl Hydroxy Stearate Benzoate Benzoate (Sold as Finsolv A were mixed together in the main kettle and slowly heated BOHS from Fenetex, Elmwood Park, N.J.), C12–15 Alkyl to 70-75° C. (“Phase A Mixture”). The ingredients of Phase Benzoate Benzoate (Sold as Finsolv TN from Finetex, B were mixed together in an oil phase kettle and then slowly Elmwood Park, N.J.), and Methyl Gluceth-20 Benzoate 40 heated to 70-75° C. (“Phase B Mixture”). The Phase A (Sold as Finsolv EMG-20 from Finetex, Elmwood Park, Mixture was placed into a homomixer and the machine was N.J.), and Liquapar Oil TM (Sutton Labs, Charlotte, N.C.). set at 70 rpm. Phase B Mixture was slowly added to the The carmine powder was dissolve into the water of Phase Phase A Mixture in the homogenizer, and the resulting A in the main kettle. Once the carmine powder dissolved, mixture was allowed to mix for one minute. The resulting caramel was added to the main kettle. The resulting mixture 45 mixture was then allowed to cool to 40°C. (“Mixture AB”). was stirred well until the caramel completely dissolved. The The beta-carotene was then added to Mixture AB (“Mixture Xantangum and magnesium aluminum Silicate were mixed ABC"). The ingredients of Phase D were mixed together in together and then added to the main kettle. The main kettle a separate kettle (“Phase D Mixture”), and then added to Solution was then Slowly heated. The glycerin, methyl Mixture ABC. The resulting self-tanning cream has a pH of propanediol, and Sorbitol were added to the heated Solution 50 4-4.8 and a viscosity of 10,000 to 30,000 cps. in the main kettle. Once the magnesium aluminum Silicate became fully hydrated, the remaining ingredients of Phase A It is understood that while the invention has been were added to the main kettle. The resulting mixture was described in conjunction with the detailed description heated to 80-85° C. (Phase A Mixture). thereof, that the foregoing description is intended to illus All of the ingredients of Phase B were mixed together in trate and not limit the Scope of the invention, which is an oil phase kettle, and the resulting mixture was heated to 55 defined by the Scope of the appended claims. Other aspects, 80–85°C. (“Phase B Mixture”). The Phase A Mixture was advantages, and modifications are within the claims. then placed into a homomixer and the machine was set at 70 What is claimed is: rpm. The Phase B Mixture was slowly added to the 1. A composition comprising carmine and a Self-tanning homomixer, and the resulting mixture was allowed to mix agent. for one minute. The resulting mixture was then allowed to 60 2. A composition of claim 1, wherein Said composition cool to 40° C. (“Mixture AB”). further comprises caramel. The ingredients of Phase C were mixed together in a 3. A composition of claim 2, wherein the weight ratio separate kettle (“Phase C Mixture'), and then added to between Said carmine and Said caramel is between about 1:1 Mixture AB (“Mixture ABC”). Lastly the fragrance was to about 1:100. added to Mixture ABC. The resulting self-tanning cream has 65 4. A composition of claim 1, wherein Said composition a pH of 4.0–4.8 and a viscosity of between 10,000 and comprises about 0.001% to about 1%, by weight, of car 30,000 cps. C. US 6,214,322 B1 9 10 5. A composition of claim 1, wherein Said Self-tanning 18. A cosmetic product of claim 17, wherein said com agent is Selected from the group consisting of 1,3- position further comprises beta-caroteine. dihydroxyacetone and 1,3,4-trihydroxy-2-butanone. 19. A product of claim 13, wherein said cosmtically 6. A composition of claim 1, wherein Said Self-tanning acceptable carrier comprises one or more of the members agent is 1,3-dihydroxyacetone. Selected from the group consisting of acidifying agents, 7. A composition of claim 2, wherein Said Self-tanning agent is 1,3-dihydroxyacetone. alkalizing agents, aerosol propellants, antimicrobial agents, 8. A composition of claim 3, wherein Said Self-tanning antioxidants, buffering agents, chelating agents, coloring agent is 1,3-dihydroxyacetone. additives, dermotologically active agents, dispersing agents, 9. A composition of claim 4, wherein Said Self-tanning emollients, emulsifying agents, humectants, fragrances, agent is 1,3-dihydroxyacetone. preservatives, Sugars, SunScreen agents, Surfactants, Sus 10. A composition of claim 1, wherein Said composition pending agents, thickening agents, and Vehicles. further comprises beta-caroteine. 20. A product of claim 17, wherein said cosmtically 11. A composition of claim 2, wherein Said composition acceptable carrier comprises one or more of the members further comprises beta-caroteine. 15 Selected from the group consisting of acidifying agents, 12. A composition of claim 9, wherein Said composition alkalizing agents, aerosol propellants, antimicrobial agents, further comprises beta-caroteine. 13. A cosmetic product for application to the hair, Skin, or antioxidants, buffering agents, chelating agents, coloring nails of a Subject for the purpose of tanning, coloring, and/or additives, dermotologically active agents, dispersing agents, darkening the same comprising: emollients, emulsifying agents, humectants, fragrances, (a) a composition according to claim 1; and preservatives, Sugars, SunScreen agents, Surfactants, Sus (b) a cosmetically acceptable carrier. pending agents, thickening agents, and Vehicles. 14. A cosmetic product of claim 13, wherein Said cosmetic 21. A method of tanning, coloring, and/or darkening the product further comprises caramel. hair, Skin, or nails of a Subject, Said method comprising 15. A cosmetic product of claim 14, wherein the weight 25 applying to the same an effective amount of the product ratio between Said carmine and Said caramel is between according to claim 13. about 1:1 to about 1:100. 22. A method of tanning, coloring, and/or darkening the 16. A cosmetic product of claim 15, wherein said cosmetic hair, Skin, or nails of a Subject, Said method comprising product comprises between about 0.001% to about 1% by applying to the same an effective amount of the product weight, of carmine. according to claim 20. 17. A cosmetic product of claim 16, wherein said self tanning agent is 1,3-dihydroxyacetone.

UNITED STATES PATENT AND TRADEMARK OFFICE CERTIFICATE OF CORRECTION

PATENT NO. : 6,214,322 B1 Page 1 of DATED : April 10, 2001 INVENTOR(S) : Castro et al.

It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below:

Column 10, claim 19 Line 3, change "cosmtically' to -- cosmetically --.

Column 10, claim 20 Line 13, change 'cosmtically' to -- cosmetically --.

Signed and Sealed this Twenty-sixth Day of March, 2002

JAMES E ROGAN Attesting Officer Director of the United States Patent and Trademark Office