CLIAMS:1. A composition comprising (a) ß-Carotene; and (b) FD&C Y.6, wherein said composition absorbs High energy visible (HEV) light radiation (400nm to 500nm), wherein said ß-Carotene and said FD&C Y.6 dye are present in the ratios of from 7:3 to 4:6.
2. The composition as claimed in claim 1, wherein said (a) ß-Carotene; and said (b) FD&C Y.6 are present in an amount 0.001% to 5% by weight, preferably 0.001 to 1% by weight, most preferably 0.01 to 0.03% by weight of the total composition.
3. The composition as claimed in claim 1, wherein said composition further comprises cosmetically acceptable excipients comprising of at least one solvent, at least one chelating agent, at least one thickening agent, at least one emulsifier, and three sunscreens.
4. The composition as claimed in claim 1, wherein said composition is formulated into a topical composition.
5. The composition as claimed in claim 4, wherein said composition is formulated into sun protection lotion or a sun protection gel.
6. A cosmetic method of inhibiting HEV radiation absorption by skin upon exposure to sunlight, said method comprising: (a) obtaining a composition as claimed in claims 1 to 5 or a formulation comprising a composition as claimed in claims 1 to 5; and (b) contacting skin with said composition or formulation, wherein said method inhibits HEV radiation absorption by skin.
7. A method of preparing a sun protection lotion, said method comprising (a) preparing a water phase to obtain a mix A; (b) preparing an oil phase to obtain a mix B; (c) contacting mix A and mix B to obtain an emulsified mix C; and (d) adding a composition comprising ß-Carotene and FD&C Y.6 dye in the ratios of from 7:3 to 4:6, and at least one neutralizer to emulsified mix C to obtain said sun protection lotion, wherein said water phase comprises of at least one solvent, at least one chelating agent, at least one thickening agent, and at least one emulsifier, and wherein said oil phase comprises of at least one emulsifier.
8. A method of preparing a sun protection gel, said method comprising of mixing at room temperature, at least one solvent, at least one chelating agent, at least one thickening agent, a composition comprising ß-Carotene and FD&C Y.6 dye in the ratios of from 7:3 to 4:6, and at least one neutralizer.
,TagSPECI:Field of the invention
The present invention relates to a cosmetic composition. More preferably it relates to a sunscreen composition.
Background and the prior art
Ultraviolet radiation (UVR), a major culprit in skin damage (Massimiliano Gentile et al. 2003, Nucleic Acids Research, Vol. 31(16)4779- 4790), is divided to three regions based on ensuing biological affects, UVC (200- 280nm), UVB (280-315nm) and UVA (315-400nm). UVC though being most toxic is mainly reflected by stratospheric ozone and hence does not reach the Earth’s surface (Kumar et al. 2009, Indian J. of Experimental Biology, 47: 906-910). Ten percent of penetrating UVR is UVB which plays a predominant role in photocarcinogenesis by DNA damage (M. Ichihashi et al. 2003, Toxicology, 189: 21-39). UVB also causes photoageing by directly upregulating the matrix metalloproteinases (MMPs) that degrade proteins in extracellular matrix. UVB also leads to ‘delayed tanning’ (Wonseon Choi et al. 2010, Journal of Investigative dermatology, 130: 1685-1696). In contrast, UVA is estimated to contribute only 10-20% to the carcinogenicity of sunlight (Desiree Wiegleb Edstrom et al. 2001, Photodermatology, Photoimmunology and Photomedicine, 17(2):66-70), but is majorly involved in causing photoageing owing to its greater penetration to the skin dermis. UVA generates reactive oxygen species (ROS) and causes immediate pigment darkening (IPD) as well as persistent pigment darkening (PPD) of skin (Wonseon Choi et al. 2010, Journal of Investigative dermatology, 130: 1685-1696).
To combat the harmful effects of UV radiation 23 UVB and UVA sunscreens approved by EU are available in the market. Aside from avoiding sunburn, modern-day sunscreen also has the potential to prevent skin cancer and slow photo-ageing (Uli Osterwalder. 2011, Expert Rev. Dermatol. 6(5), 479–491). The earliest sunscreens had offered protection only against UVB radiation. Further research established deleterious effects of even UVA radiation on skin. This led to the advent of UVA sunscreens thereby providing broad-spectrum UVB and UVA protection.
Effect of UV on photo damage of skin is obvious, for which various sunscreens are available to protect the skin. However, the effect of visible light on photo damage of skin is currently being explored in detail. Blue region of the visible spectrum also known as High energy visible light (HEV) (from 400 to 500nm wavelength) is likely to be particularly important because it has a relatively high energy, can penetrate tissues and is associated with the occurrence of malignant melanoma in animal models (Sebastian Di Cesare et al. 2009, Journal of Experimental & Clinical Cancer Research, 28:48). Blue light (BL) interacts with cellular chromophores such as melanin and lipofuscin in pigmented cells, retinoids in photoreceptor cells and flavin-containing oxidases, cytochrome system, heme-containing proteins, and tryptophan rich proteins in non-pigmented cells. The interaction of these chromophores with light can generate Reactive oxygen species (ROS), which in turn can damage lipids, proteins, and DNA. Role of damage of the above is pivotal in skin ageing.
Even though the deleterious effects of BL or HEV on human skin is being looked into in great detail by the scientific community there are no sunscreen- like molecules identified which can absorb BL and thereby protect the skin from getting damaged.
Various prior art exist which discloses combination of sunscreen with various dyes for various purposes. US6290936 discloses colored, sunscreen emulsion is disclosed which employs a water soluble dye or a blend of water-soluble dyes whose color substantially disappears when the sunscreen emulsion dries after it is spread on the skin and/or is rubbed out. The coloration in the sunscreen enables the user to more effectively protect against sunburn by allowing more complete and uniform coverage of the sunscreen on the skin. The sunscreen emulsion comprises : a) at least one water-soluble dye that imparts a color other than white to the sunscreen emulsion, such that when the sunscreen emulsion dries after it is spread on the skin and/or is rubbed out, the color substantially disappears; b) at least one sunscreen active in an amount effective to protect against the actinic radiation of the sun; c) at least one emulsfier; d) sufficient water to form the colored emulsion; e) optionally, one or more emollients, humectants, dry-feel agents, waterproofing agents, preservatives, antioxidants, chelating agents and fragrances as well as any other class of materials whose presence may be cosmetically, efficaciously or otherwise desirable.
EP0420713 discloses dual-function skin treatment formulation and method for simultaneously moisturizing and imparting durable color to the skin. The formulation is an oil-in-water type emulsion, containing an aqueous phase which includes a dye and an alcohol, and an oil phase containing an emollient and an emulsifier. The formulation has a pH less than or equal to 7, and may advantageously include additional ingredients, such as a sunscreen, humectant or a water repellent. The formulation has a variety of applications, including treating skin depigmentation/decolorization, enhancing skin color and using as a fantasy make-up. EP’713 discloses use of F&D C Y6 with sunscreen.
WO2004050050 discloses a sunscreen composition for topical application containing an absorber for radiation at the wavelengths 475 to 515 nm and 595 to 610 nm, wherein the absorber is a dye or mixture of dyes. The absorber mentioned in WO2004050050 absorbs radiation at wavelengths 475 to 515 and 595 to 610nm.
US2011033400 discloses cosmetic formulation comprising (a) particulates having an absorption in the range of 400 to 800 nm; and (b) UV filters selected from (b1) particulate organic UV-filters; and (b2) soluble organic UV filters. US’400 disclose combination of pigments including ß -carotene and FD&C Y.6.
However most sunscreen formulations are used for protection against UVB and UVA radiation only. None of the prior art demonstrates the synergistic combination of two pigments which is effective in absorbing the High energy visible light from 400 to 500nm.

Object of the invention
It is an object of the present invention to overcome the drawbacks of the prior art.
It is a further object of the present invention to provide a sunscreen composition which attenuates BL or HEV radiation by absorbing visible light from 400 to 500nm.
It is still further object of the present disclosure to provide a method of inhibiting HEV radiation absorption by skin upon exposure to sunlight.
It is still further object of the present disclosure to provide a process for preparing a sunscreen composition.
It is still further object of the present disclosure to provide a sunscreen composition in various forms which includes but not limited to lotions, serums, oils, sprays, gels and gel-crems.

Summary of the invention
Accordingly to one aspect of the present invention there is provided a composition comprising (a) ß-Carotene; and (b) FD&C Y.6, wherein said composition absorbs High energy visible (HEV) light radiation (400nm to 500nm), wherein said ß-Carotene and said FD&C Y.6 dye being present in the ratios of from 7:3 to 4:6.
Accordingly to another aspect of the present invention there is provided a cosmetic method of inhibiting HEV radiation absorption by skin upon exposure to sunlight, said method comprising: (a) obtaining a composition or a formulation comprising a composition as described herein; and (b) contacting skin with said composition or formulation, wherein said method inhibits HEV radiation absorption by skin.
Accordingly to a further aspect of the present invention there is provided a method of preparing a sun protection lotion as described herein, said method comprising (a) preparing a water phase to obtain a mix A; (b) preparing an oil phase to obtain a mix B; (c) contacting mix A and mix B to obtain an emulsified mix C; and (d) adding a composition comprising ß-Carotene and FD&C Y.6 dye in the ratios of from 7:3 to 4:6, and at least one neutralizer to emulsified mix C to obtain said sun protection lotion, wherein said water phase comprises of at least one solvent, at least one chelating agent, at least one thickening agent, and at least one emulsifier, and wherein said oil phase comprises of at least one emulsifier.
Accordingly to a yet another aspect of the present invention there is provided a method of preparing a sun protection gel as described herein, said method comprising of mixing at room temperature at least one solvent, at least one chelating agent, at least one thickening agent, a composition comprising ß-Carotene and FD&C Y.6 dye in the ratios of from 7:3 to 4:6, and at least one neutralizer.

Brief description of accompanying Figures
Fig. 1a depicts the absorbance spectrum of 7parts of ß-Carotene, 3parts of FD&C Y.6 individually and collectively in a ratio of 7:3.
Fig.1b depicts the synergy demonstrated by the combination of ß-carotene and FD&C Y.6 in a ratio of 7:3
Fig. 2a depicts the absorbance spectrum of 6parts of ß-Carotene, 4parts of FD&C Y.6 individually and collectively in a ratio of 6:4.
Fig.2b depicts the synergy demonstrated by the combination of ß-carotene and FD&C Y.6 in a ratio of 6:4 where synergy between the molecules is observed in the means of absorption of HEV range of visible light from 396 to 524nm.
Fig. 3a depicts the absorbance spectrum of 5parts of ß-Carotene, 5parts of FD&C Y.6 individually and collectively in a ratio of 5:5.
Fig.3b depicts the synergy demonstrated by the combination of ß-carotene and FD&C Y.6 in a ratio of 5:5 where synergy between the molecules is observed in the means of absorption of HEV range of visible light from 408 to 516nm.
Fig. 4a depicts the absorbance spectrum of 4parts of ß-Carotene, 6parts of FD&C Y.6 individually and collectively in a ratio of 4:6.
Fig.4b depicts the synergy demonstrated by the combination of ß-carotene and FD&C Y.6 in a ratio of 4:6 where synergy between the molecules is observed in the means of absorption of HEV range of visible light from 427 to 510nm.
Fig. 5 depicts the absorption spectrum of ß-Carotene and FD&C Y.6 in a ratio of 9:1
Fig. 6 depicts the absorption spectrum of ß-Carotene and FD&C Y.6 in a ratio of 8:2
Fig. 7 depicts the absorption spectrum of ß-Carotene and FD&C Y.6 in a ratio of 3:7
Fig. 8 depicts the absorption spectrum of ß-Carotene and FD&C Y.6 in a ratio of 2:8
Fig. 9 depicts the absorption spectrum of ß-Carotene and FD&C Y.6 in a ratio of 1:9
Fig.10 depicts the absorption spectrum of combination of ß-Carotene and Acid blue 9 at 9:1 ratio
Fig.11 depicts the absorption spectrum of combination of ß-Carotene and Acid blue 9 at 8:2 ratio
Fig.12 depicts the absorption spectrum of combination of ß-Carotene and Acid blue 9 at 7:3 ratio
Fig.13 depicts the absorption spectrum of combination of ß-Carotene and Acid blue 9 at 6:4 ratio
Fig.14 depicts the absorption spectrum of combination of ß-Carotene and Acid blue 9 at 5:5 ratio
Fig.15 depicts the absorption spectrum of combination of ß-Carotene and Acid blue 9 at 4:6 ratio
Fig.16 depicts the absorption spectrum of combination of ß-Carotene and Acid blue 9 at 3:7 ratio
Fig.17 depicts the absorption spectrum of combination of ß-Carotene and Acid blue 9 at 2:8 ratio
Fig.18 depicts the absorption spectrum of combination of ß-Carotene and Acid blue 9 at 1:9 ratio

Detailed description of the invention
The present invention relates to a cosmetic composition which provides a protection from harmful sunrays. The present invention provides protection against the High energy visible light (HEV) radiation which also damages the skin. This protection is important in current scenario of increasing intensity of solar radiation inclusive of visible radiation reaching the Earth’s surface caused due to increased pollution levels.
The present inventors have surprisingly found that a combination of two molecules namely ß-carotene and FD&C Y.6 dye absorbs visible light from 350 to 600nm thereby attenuating BL or HEV radiation. This combination is synergistic in absorbing BL or HEV radiation in the range of 400 to 500nm wavelength. The synergy between the two molecules ß-Carotene and FD&C Y.6 dye is demonstrated in the ratios of from 7:3 to 4:6, Surprisingly, such synergy is not noted in the ratios preceding the specified range i.e. 9:1 and 8:2; and also succeeding the specified range i.e. 3:7, 2:8 and 1:9 between ß-Carotene and FD&C Y.6 dye respectively.
The synergistic combination of the present invention can be present in an amount 0.001% to 5% by weight, preferably 0.001 to 1% by weight, most preferably 0.01 to 0.03% by weight of the total composition.
The combination of the present invention can be formulated into skin and hair care formulations which are generally applied when outdoors to provide protection against the solar radiation inclusive of HEV radiation, and indoors to protect against HEV radiation alone:
Sunscreen formulations (lotions/ serums/ oils/ sprays/ gels/ gel-crèmes)
Moisturizing formulations (lotions/ serums/ oils/ sprays/ gels/ gel-crèmes)
Lip care balms/ gels/ jelly
Hair protective serums/ sprays/ gels/ oils
Anti-ageing formulations (lotions/ creams/ serums/ gels/ gel-crèmes)
Skin lightening formulations (lotions/creams/ serums/ gels/ gel-crèmes)
Accordingly to another aspect of the present invention there is provided a composition comprising the synergistic combination of the present invention. The composition of the present invention further comprises cosmetically acceptable excipients comprising of at least one solvent, at least one chelating agent, at least one thickening agent, at least one emulsifier, and three sunscreens.
Solvents used in the present invention are selected from water, alcohol (ethanol, isopropyl alcohol), silicones and mixtures thereof. Solvents may be present in amounts 30 to 90 % by weight.
Chelating agent used in the present invention is EDTA. Various chelating agents may be used as optional constituents of the instant invention. These may be selected from a group consisting of but not limited to Dimercaptosuccinic acid (DMSA), Dimercapto-propane sulfonate (DMPS), Alpha lipoic acid (ALA), Calcium disodium versante (CaNa2-EDTA), Disodium EDTA, Dimercaprol (BAL). The concentrations of the various chelating agents may be about 0.1 to 1 percent by weight; preferably about 0.2 to about 0.5 percent by weight.
Thickeners which may be used in the instant invention include but are not restricted to alkyloamides, carbomer 934, 940, 941, 960, 961, cetearyl alcohol, cetyl alcohol, gelatin, gums, and magnesium aluminium silicates, ozocarite, paraffin, tragacanth, sodium alginate, Tinovis ADM, Acrylates/C10-30 Alkyl Acrylate Crosspolymer and ammonium Acryloyl - dimethyltaurate / Vinyl pyridine Copolymer/Carbomer, Hydroxyethyl Acrylate / Sodium AcryloyldimethylTaurate Copolymer (and) Isohexadecane (and) Polysorbate 60, Simugel INS 100 , CarbopolUltrez 10 and the like. The concentrations of the thickeners may be about 0.1% by weight to about 2% by weight; preferably about 0.5% by weight to about 1% by weight.
Emulsifying agents which may be optionally added to the compositions of the present invention include but are not restricted to oxyalkylenated fatty acid esters of polyols, for example polyethylene glycol stearates, for instance PEG-100 stearate, PEG-50 stearate and PEG-40 stearate; and mixtures thereof, mixture of glycerylmonostearate and of polyethylene glycol stearate (100 EO) (Simulsol 165), oxyalkylenated fatty acid esters of sorbitan comprising, for example, from 20 to 100 EO such as Tween 20 or Tween 60, oxyalkylenated (oxyethylenated and/or oxypropylenated) fatty alcohol ethers; alkoxylated or non-alkoxylated sugar esters, such as sucrose stearate and PEG-20 methylglucosesesquistearate; sorbitan esters such as the sorbitanpalmitate (Span 40), esters of diacid and of fatty alcohol, such as dimyristyl tartrate; mixtures of these emulsifiers, for instance the mixture of glyceryl stearate and of PEG-100 stearate (Arlacel 165), and mixtures comprising these emulsifiers, such as the mixture of dimyristyl tartrate, cetearyl alcohol, Pareth-7 and PEG-25 laureth-25, (Cosmacol PSE) , steareth – 2, steareth 21, PPG-15 stearyl ether. The concentrations of the emulsifying agents may be about 0.1% by weight to about 8.0% by weight; preferably about 0.4% by weight to about 4.0% by weight.
Other optional Sunscreens used in the present invention are selected from Octocrylene, ethyl methoxy cinnamate, Avobenzone, Octisalate, Homosalate, Bisdisulizole Disodium, Ensulizole, Mexoryl XL, Mexoryl SX, Titanium dioxide, Zinc oxide, Bisoctrizole, Bemotrizinol, Tinosorb A2B, oxybenzone, Benzophenone-4, and mixtures thereof. Sunscreen may be present in amounts 1 to 10% by weight.
In an aspect of the present invention, there is also provided a cosmetic method of inhibiting HEV radiation absorption by skin upon exposure to sunlight, said method comprising: (a) obtaining a composition comprising (a) ß-Carotene; and (b) FD&C Y.6 or a formulation comprising a composition as described herein; and (b) contacting skin with said composition or formulation, wherein said method inhibits HEV radiation absorption by skin.
In a preferred embodiment of the present invention the composition of the present invention is a sun protection lotion. The sun protection lotion of the present invention can be prepared by a method comprising steps of (a) preparing a water phase to obtain mix A; (b) preparing an oil phase to obtain mix B; (c) contacting mix A and mix B to obtain an emulsified mix C; and (d) adding a composition comprising (a) ß-Carotene; and (b) FD&C Y.6, and at least one neutralizer to emulsified mix C to obtain said sun protection lotion, wherein said water phase comprises of at least one solvent, at least one chelating agent, at least one thickening agent, and at least one emulsifier, and wherein said oil phase comprises of at least one emulsifier.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the at least one solvent in step (a) is a polar solvent.
In a more preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the at least one solvent in step (a) is water.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the at least one chelating agent in step (a) is EDTA.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the w/w concentration of the at least one chelating agent in step (a) is 0.1% of said formulation.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the at least one thickening agent in step (a) is Carbolpol Ultrez 10.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the w/w concentration of the at least one thickening agent in step (a) is 1.5% of said formulation.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the at least one emulsifier in step (a) is Brij 721.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the w/w concentration of the at least one emulsifier in step (a) is 2% of said formulation.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the at least one emulsifier in step (b) is Brij 72.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the w/w concentration of the at least one emulsifier in step (b) is 1% of said formulation.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein different oil soluble sunscreen agents are incorporated in step (b) Octocrylene, Octisalate and Avobenzone.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the w/w concentration of the sunscreen agents in step (b) is 5%, 5% and 2% of said formulation respectively.
In an embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the step (a) is carried out at about 45-85°C.
In an embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the step (b) is carried out at about 85°C.
In an embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein step (d) comprises of at least one neutralizer, and a composition comprising of ß-Carotene and FD&C Y.6 as described herein.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the at least one neutralizer in step (d) is triethanolamine.
In a preferred embodiment of the present invention, there is provided a method of preparing a sun protection lotion as described herein, wherein the w/w concentration of the at least one neutralizer in step (d) is 1.5% of said formulation.
According to a further aspect of the present invention there is provided a method for preparing the composition of the present invention in the form of a sun protection gel.
In an aspect of the present invention, there is provided a method of preparing a sun protection gel, said method comprising of mixing at room temperature at least one solvent, at least one chelating agent, at least one thickening agent, a composition comprising (a) ß-Carotene; and (b) FD&C Y.6, and at least one neutralizer, said ß-Carotene and said FD&C Y.6 dye being present in the ratios of from 7:3 to 4:6.

The invention is now illustrated by way of non-limiting examples.
Example 1
Sunscreen lotion with ß-Carotene and FD&C Y.6 dye:
Table 1
Lotion/Cream # Ingredients % w/w
Water Phase 1 Distilled Water QS
2 Chelating agent(E.g. EDTA) 0.1
3 Thickening agent(E.g. Carbopol Ultrez 10) 1.5
4 Emulsifier A – Water Phase(E.g. Brij 721) 2
Oil Phase 5 Emulsifier B – Oil Phase(E.g. Brij 72) 1
6 Octocrylene 5
7 Octisalate 5
8 Avobenzone 2
Post emulsification 9 Triethanolamine 1.5
10 B-Carotene 0.03
11 FD&C Y.6 0.02

Process for preparation of lotion/cream:
Step 1: Water Phase is prepared by adding and mixing ingredients 1 through 4 at predetermined temperature ranges of from about 45°C to 85°C.
Step 2: Oil Phase is prepared by separately adding and mixing ingredients 5 through 8 and maintaining temperature up to 85°C as well.
Step 3: Emulsifing the Water Phase of Step 1 with the Oil Phase of Step 2. Adding ingredients 9, 10 and 11 to the emulsion to obtain cosmetic compositions of the present invention.

Example 2:
Gel formulation with ß-Carotene and FD&C Y.6 dye:
Table 2
Gel # Ingredients % w/w
Water Phase 1 Distilled Water QS
2 Chelating agent(E.g. EDTA) 0.1
3 Thickening Agent(E.g. Carbopol Ultrez 10) 1.5
4 B-Carotene 0.03
5 FD&C Y.6 0.02
6 Triethanolamine 1.5

Process for preparation of gel
Preparing a prototype by adding and mixing sequentially all ingredients from 1 through 6 at room temperature to obtain cosmetic compositions of the present invention. Thorough mixing/dispersion of each ingredient is ensured in the formulation

Example 3
Various experiments were performed to show that the combination of the present invention shows synergy in absorbing HEV range of visible light
ß-Carotene was dissolved in water for generating absorption spectra.
FD&C Y.6 was dissolved in water for generating absorption spectra.
Generation of absorption spectra
Absorption spectrum of individual molecules ß-Carotene and FD&C Y.6 and that of their combination was determined by a UV-visible spectrophotometer by spectral scan from 200 to 800nm. N parts of a particular extract means N% of that extract.
In the figures below, the term “calculated value” refers to additive effect as should be received theoretically from a combined effect of the individual actives. The term “experimental value” refers to the value of the combined effect of the individual actives as actually received by conducting the experiment.
Fig. 1a depicts the absorbance spectrum of 7parts of ß-Carotene, 3parts of FD&C Y.6 individually and collectively in a ratio of 7:3. The graph of ‘experimental value of ß-carotene and FD&C Y.6 at 7:3’ shows that this combination absorbs light from 350 to 600nm encompassing partial UVA, whole of blue, green, yellow and orange regions of visible light, whereas ß-carotene alone absorbs light from 369 to 600nm and FD&C Y.6 absorbs from 433 to 538 nm.
Fig.1b depicts the synergy demonstrated by the combination of ß-carotene and FD&C Y.6 in a ratio of 7:3 where synergy between the molecules is observed in the means of absorption of HEV range of visible light from 420 to 509nm. (The area of the graphs ‘Experimental value of ß-carotene and FD&C Y.6 in 7:3’ and ‘Calculated additive value of ß-Carotene and FD&C Y.6’ where the experimental value is higher than the calculated additive value represents the area where synergy is observed between the molecules).
Fig. 2a depicts the absorbance spectrum of 6parts of ß-Carotene, 4parts of FD&C Y.6 individually and collectively in a ratio of 6:4. The graph of ‘Experimental value of ß-carotene and FD&C Y.6 at 6:4’ shows that this combination absorbs light from 350 to 600nm encompassing partial UVA, whole of blue, green, yellow and orange regions of visible light, whereas ß-carotene alone absorbs light from 369 to 600nm and FD&C Y.6 absorbs from 433 to 538 nm.
Fig.2b depicts the synergy demonstrated by the combination of ß-carotene and FD&C Y.6 in a ratio of 6:4 where synergy between the molecules is observed in the means of absorption of HEV range of visible light from 396 to 524nm. (The area of the graphs ‘Experimental value of ß-carotene and FD&C Y.6 in 6:4’ and ‘Calculated additive value of ß-Carotene and FD&C Y.6’ where the experimental value is higher than the calculated additive value represents the area where synergy is observed between the molecules).
Fig. 3a depicts the absorbance spectrum of 5parts of ß-Carotene, 5parts of FD&C Y.6 individually and collectively in a ratio of 5:5. The graph of ‘Experimental value of ß-carotene and FD&C Y.6 at 5:5’ shows that this combination absorbs light from 350 to 600nm encompassing partial UVA, whole of blue, green, yellow and orange regions of visible light, whereas ß-carotene alone absorbs light from 371 to 600nm and FD&C Y.6 absorbs from 430 to 538 nm.
Fig.3b depicts the synergy demonstrated by the combination of ß-carotene and FD&C Y.6 in a ratio of 5:5 where synergy between the molecules is observed in the means of absorption of HEV range of visible light from 408 to 516nm. (The area of the graphs ‘Experimental value of ß-carotene and FD&C Y.6 in 5:5’ and ‘Calculated additive value of ß-Carotene and FD&C Y.6’ where the experimental value is higher than the calculated additive value represents the area where synergy is observed between the molecules).
Fig. 4a depicts the absorbance spectrum of 4parts of ß-Carotene, 6parts of FD&C Y.6 individually and collectively in a ratio of 4:6. The graph of ‘Experimental value of ß-carotene and FD&C Y.6 at 4:6’ shows that this combination absorbs light from 372 to 600nm encompassing partial UVA, whole of blue, green, yellow and orange regions of visible light, and ß-carotene alone absorbs light from 372 to 600nm and FD&C Y.6 absorbs from 425 to 538 nm.
Fig.4b depicts the synergy demonstrated by the combination of ß-carotene and FD&C Y.6 in a ratio of 4:6 where synergy between the molecules is observed in the means of absorption of HEV range of visible light from 427 to 510nm. (The area of the graphs ‘Experimental value of ß-carotene and FD&C Y.6 in 4:6’ and ‘Calculated additive value of ß-Carotene and FD&C Y.6’ where the experimental value is higher than the calculated additive value represents the area where synergy is observed between the molecules).
The figures 5, 6,7, 8, and 9 show that there is no synergy observed between ß-carotene and FD&C Y.6 at the respective ratios of 9:1, 8:2, 3:7, 2:8 and 1:9.

Example 4
Various samples of formulations were prepared with varying concentration of the ß-carotene or FD&C Y.6 both singly and in combination. The composition of the present invention further comprises cosmetically acceptable excipients comprising of at least one solvent, at least one chelating agent, at least one thickening agent, and at least one emulsifier.
Table 3
Ingredients % w/w
Water Q.S
Chelating agent (Ex. EDTA) 0.05
Humectant (ex: Glycerin) 1
Thickening agent (Ex: Pemulen TR2) 0.05
Thickening agent (Ex: Carbopol Ultrez 10) 0.2
Emulsifier (Ex: Brij 721) 1.8
Emulsifier (Ex: Brij 72) 0.9
Humectant (Ex: Propylene glycol) 0.5
Structurant (Ex:Stearic acid) 1
Co-emulsifier (Ex: Cetyl alcohol) 0.5
Preservative (Ex: Methyl paraben) 0.16
Preservative (Ex. Propyl paraben) 0.04
Neutralizer (Ex: Triethanolamine) 0.25
Occlusive agent (Ex: CB 3021) 3.5
Preservative (Ex: Phenoxyethanol) 0.2
Emollient (Hydramol PGPD) 1
Emollient (Arlamol HD) 2
Emollient (Shea butter) 0.5
Humectant (Hydroxy ethy urea) 1
Co-emulsifier (Ex: Novamer) 0.3
B-Carotene At concentrations mentioned in table 4
FD&C Y.6 At concentrations mentioned in table 4

ß-carotene and FD&C Y.6 were incorporated separately to the formulations at equal concentration as mentioned in table 4. Similarly, different concentrations of the combination of ß-carotene and FD&C Y.6 were incorporated to the formulation. The formulations were tested by voluntary panelists for colour likability/ preference. The efficacy of these formulations was determined by spreading the formulation at a concentration of 2mg/cm2 on Transpore tapes and exposing them to HEV light source (18W Osram Dulux L Blue). The amount of radiation transmitted through the formulations was determined by using a Radiometer against a placebo (without ß-carotene or FD&C Y.6 or both). The percentage of radiation attenuated by the formulations with ß-carotene or FD&C Y.6 or both is calculated as follows:
((Radiationplacebo – Radiationx)/ Radiationplacebo)*100
Where Radiationx is the amount of radiation transmitted through the formulation with ß-carotene or FD&C Y.6 or both. Higher is the percentage attenuation of HEV by the formulation, higher is the protection offered by the formulation to the skin or hair.
Table 4 depicts cosmetic formulations incorporated with different concentrations of either ß-carotene or FD&C Y.6 or both. The table clearly shows that the percentage of consumers who like the colour of the D and E formulations (which have less than half of amount of ß-carotene or FD&C Y.6 incorporated in the formulation than in A or B) is double than that of the consumers who like the colour of formulation A or B with either ß-carotene or FD&C Y.6 alone.
Moreover, the D and E formulations have efficacy (% HEV protection) either equivalently or higher than A or B formulations. This shows that the combination of ß-carotene or FD&C Y.6 at a synergistic ratio can be used to reduce the concentration of the individual molecules used and also obtain desirable high energy visible light (HEV) protection.

Table 4
Formula-tion code Concentration of Carotene + FD&C Y.6 dye in formulation % of Consumers who preferred the formulation colour % HEV protection
A 0.03% (30mg Carotene only) 10 5.63
B 0.03% (30mg FD&C Y.6 dye only ) 0 5.42
C 0.01% (6 mg Carotene+ 4mg FD&C Y.6 dye) 50 2.71
D 0.02% (12mg Carotene+ 8mg FD&C Y.6 dye) 20 5.21
E 0.025% (15mg Carotene+ 10mg FD&C Y.6 dye) 20 6.25
F 0.03% (18mg Carotene+ 12mg FD&C Y.6 dye) 0 7.08

Example 5
To prove that the combination of ß-carotene or FD&C Y.6 only provides the desired effect and not any other dye, ß-carotene was combined with Acid blue 9 dye at different ratios.
ß-Carotene was dissolved in water for generating absorption spectra.
Acid blue 9 was dissolved in water for generating absorption spectra.
Absorption spectrum of individual molecules ß-Carotene and FD&C Y.6 and that of their combination was determined by a UV-visible spectrophotometer by spectral scan from 200 to 800nm. N parts of a particular extract means N% of that extract.
Figures 9 to 18 proves that the combination of ß-carotene with Acid blue 9 is not synergistic at any ratio within the visible wavelength region.