Patent Description:
One example embodiment of the current invention is a sunscreen formulation with active ingredients that block as much of the damaging, cancer- causing ultraviolet radiation as possible while at the same time permitting passage of light in the wavelengths used by the body to synthesize vitamin D and for tanning.

Sunscreens are widely known and used to prevent the harmful affects of sun exposure. Each different active ingredient used in sunscreens has a unique profile in regard to which wavelengths of ultraviolet (UV) radiation it can absorb and what percentage of those wavelengths it can absorb. Traditionally sunscreen formulators, in their zeal to protect people who are exposed to sunlight from skin cancer and wrinkles, have combine complimentary active ingredients to filter UV radiation in a spectral overlap that blocks the broadest spectrum of radiation possible. This broad spectrum approach, unfortunately, also blocks the beneficial wavelengths of radiation in approximately the <NUM> to <NUM> nanometer range which are needed for vitamin D synthesis in the skin.

There is broad agreement by vitamin D researchers that getting quantities of vitamin D that are sufficient for optimum health from diet alone is difficult, that vitamin D is produced in sufficient quantities when a sensible amount of sunlight at lower latitudes penetrates the skin and that a large percentage of the population would benefit from higher levels of vitamin D.

Vitamin D plays an essential role in the prevention of bone problems (of which one in twelve people living in higher latitudes is at risk), prevention of some sixteen common cancers (which together are responsible for <NUM> times more deaths than skin cancer) and modulation of neuromuscular and immune function. Research also indicates that sufficient levels of vitamin D may prevent or reduce the incidence of inflammation, multiple sclerosis, rheumatoid arthritis, hypertension, lupus, cardiovascular disease, type <NUM> diabetes and type <NUM> diabetes. Obesity is associated with lower circulating vitamin D levels.

Disclosed are significant, untapped health benefits and considerable commercial potential by the current invention.

Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to others, available as a dietary supplement and produced when ultraviolet (UV) rays from sunlight (or tanning beds) enter the skin. Essentially all terrestrial vertebrates, including humans, obtain most of their vitamin D requirement from casual exposure to sunlight. Application of a sunscreen, increased skin pigmentation, aging, hair and clothing all reduce vitamin D production in the skin.

Vitamin D is made in the body when a derivative of cholesterol called <NUM>-dehydrocholesterol is converted to pre-vitamin D3 using the energy from radiation that has entered the skin. Pre-vitamin D3 then spontaneously changes itself into its isomer, vitamin D3. Vitamin D3 is then changed to <NUM>-hydoxyvitamin D3 which circulates in the blood serum or is stored in the liver until needed. <NUM>-hydroxyvitamin D3 is later changed in the kidneys or elsewhere into <NUM>,<NUM>-dihydroxyvitamin D3, the main biologically active form.

Following are synonyms: pre-vitamin D3 is cholecalciferol; <NUM>- hydoxyvitamin D3 is <NUM>(OH)D3 or calcidiol; <NUM>,<NUM>-dihydroxyvitamin D3 is <NUM>,<NUM>(OH)2D3 or calcitriol. In this patent vitamin D stands for vitamin D3, and is sometimes used in a general sense.

The amount of sunscreen (or sunblock) applied to the skin can influence how much of the incoming UV radiation is absorbed, with a thicker layer generally absorbing more radiation. The current invention eliminates certain active ingredients which are known to be sticky or oily, especially in higher concentrations. One advantage of the current invention over traditional sunscreen concoctions is, surprisingly, overall better skin protection because the behavior of sunscreen users is such that they tend to use larger quantities and tend to re-apply more frequently when the ingredients are not as sticky or oily.

The action spectrum of epidermal vitamin D photosynthesis can be graphed in an absorbance curve showing that the peak absorbance for vitamin D synthesis is at about <NUM>, with large amounts produced between <NUM> and <NUM>, and lesser amounts produced farther from the peak of the curve between <NUM> and <NUM> and between <NUM> and <NUM>. (Wavelengths between <NUM> and <NUM> will cause vitamin D synthesis, but are for the most part filtered by the atmosphere, and therefore generally do not reach the body. ) As the wavelengths increase from <NUM> to <NUM>, so does the relative intensity of UVB radiation reaching the earth's surface. Therefore as a practical matter, it has been discovered that although the absorbance by vitamin D precursors is highest in the <NUM> to <NUM> range, there is at the surface of the earth a higher intensity of UVB radiation available to the skin between <NUM> and <NUM> than is available between <NUM> to <NUM>.

An important consideration of the current Invention is that although the range of radiation that is filtered by the current invention's appropriate UV filter(s) may overlap part of all of the absorption range needed for vitamin D production (i.e. approximately <NUM> to <NUM>), the active ingredient(s) of the current invention permit the passage of sufficient quantity and quality of radiation for the body to effectively produce vitamin D. The current invention discloses a surprising improvement in sunscreen formulation that teaches away from mainstream full-spectrum screening approach.

Organic molecules known as UV filters (i.e. the active ingredients in sunscreens) have multiple atoms which can vibrate and rotate in relation to each other. Many closely spaced energy transitions mean that instead of absorbing exact frequencies of radiation, molecules absorb groups of frequencies of radiation. The many closely spaced absorption lines combine to make an absorption band. Sunscreens made from organic molecules absorb different percentages of the radiation. These percentages of absorption can be graphed as an absorption curve, with a range (i.e. the shortest to longest wavelengths absorbed) and the peak absorption (i.e. the wavelength which is most highly absorbed). The absorption range and the peak absorption vary by organic molecule. Different organic molecules have differences in how quickly their absorption drops off ("fat" curves as compared to "skinny" curves).

It is important to realize that even within an organic molecule's absorption range, it does not absorb evenly and absorptions near the ends of the range are usually low. Sunscreen manufacturers typically use several active ingredients for screening different parts of the UV spectrum, thereby providing protection from a broad spectrum of radiation.

Factors can influence the determination of the absorbance maximum and other spectral curve data, both for UV filters and vitamin D production, and it should be understood that the overriding essence of the present invention is to permit vitamin D synthesis by the body while blocking out other harmful wavelengths of radiation. For example, <NUM>-aminobenzoic acid (PABA) has a maximum absorbance between <NUM> and <NUM> in its crystalline form, <NUM> when dissolved in alcohol, and <NUM> when dissolved in water. Therefore, formulations presented in the current invention which include or exclude UV filters based all or in part on the UV filter's absorbance maximum or other spectral curve data are not definitive and are subject to change.

The color of human skin is principally determined by two factors: constitutive pigmentation (which is the genetically-determined color of the skin) and facultative pigmentation (which is an acquired tan). About <NUM> hours after the skin has been exposed to UVB radiation in approximately the <NUM> to <NUM> range, a long-lasting base tan (facultative pigmentation) is most noticeable. This delayed tanning is an increase in melanin, through a process called melanogenesis. This invention is a sunscreen that permits the passage of a substantial portion of UVB light in the <NUM> to <NUM> nanometer range, thereby permitting the acquisition of a long-lasting base tan while blocking other harmful wavelengths. The sunscreen formulations of the current invention are surprisingly different from all other sunscreens in that those sunscreens filter a broad-spectrum of light, thereby blocking one's ability to get a long-lasting base tan.

Ultraviolet (UV) radiation for the most part comes from the sun and cannot be seen by the human eye, but can be measured with Instruments. It is commonly divided into three ranges according to wavelengths: UVA, UVB and UVC.

UVA radiation is wavelengths of light between <NUM> and <NUM> nanometers (nm), and accounts for <NUM> percent of solar UV radiation reaching the earth. UVA radiation has the ability to penetrate deeply into the epidermis and the dermis. Human exposure to UVA radiation has been associated with melanoma, premature aging, sagging, wrinkling skin, sun spots, tanning and immunologic effects. Formulations of the current Invention provide substantial screening across the UVA range.

UVB radiation is wavelengths of light between <NUM> and <NUM>, and is partially absorbed by ozone in the atmosphere, especially in the <NUM> to <NUM> range. UVB radiation does not generally have the ability to penetrate past the epidermis into the dermis. Human exposure to sufficient UVB radiation will cause the skin to become sunburn and exhibit redness (erythema). Sunscreen formulations as disclosed in the current invention surprisingly result in a safe and sensible balance between permitting the passage of enough UVB radiation in the neighborhood of <NUM> to <NUM> for the body to synthesize a disease-opposing amount of vitamin D while not permitting so much UVB radiation as to induce appreciable erythema. UVB radiation in the range of approximately <NUM> to <NUM> is necessary for vitamin D synthesis and, as per the current invention, that range is on the whole desirable for absorption by the skin.

UVC radiation is wavelengths of light between <NUM> to <NUM>, and is, for all intensive purposes, filtered from reaching the earth's surface by atmospheric oxygen, ozone and water vapor. UVC radiation is potentially the most detrimental to DNA and RNA. "Ultraviolet radiation in the region of <NUM> can cause photochemical reactions in deoxyribonucleic molecules causing mutations and destroying microorganisms, including bacteria and viruses.

<CIT> relates to the use of <NUM>-hydroxycholecalciferol as an active ingredient in the manufacture of topical compositions which contain a UV-B screening agent for the prevention of vitamin D deficiencies caused by the topical application of such UV-B screening agents.

It is an object of the present invention to create an improved sunscreen promoting tanning and vitamin D generation, but protects the skin from damage.

This is achieved according to the present invention by a composition suitable for providing protection against ultraviolet radiation through which ultraviolet B radiation is permitted to enter the skin in an amount sufficient for the body to produce a healthful and disease-opposing quantity of vitamin D<NUM> and Chemical precursors thereof.

The present invention and its preferred embodiments are apparent from the appendant set of claims.

Samples of vitamin D promoting sunscreen formulations that were manufactured by the inventor in various concentrations were measured using a photospectrometer for their absorption spectra.

Adult humans (two male and two female) have successfully applied the vitamin D promoting sunscreen in various concentrations to their skin prior to exposure to the sun, their initials are: NS, JT, EA, and AG.

Recent research, in part by the inventor, has demonstrated that the body has defenses against the harmful effects of radiation in the vitamin D producing range. When using a sunscreen with one of the current invention's formulations, the user will be protected from unwanted or excess UVB radiation for the following reasons:
One surprising discovery of the current invention is that from a standpoint of protection from UVB radiation, the pre-vitamin D3 absorbance range (i.e. <NUM> to <NUM>) has a safety advantage over other ranges of UV radiation absorption precisely because of the absorbance by pre-vitamin D3. As such, pre-vitamin D3 can be viewed as not only a chemical with important biological functions but also as a UV filter itself, protecting other biochemicals in its absorbance range. One critical and distinguishing feature of the current invention in regard to the prior art is that others, who are skilled in the art of sunscreen formulation, have consistently over many years recommended overlapping, broad-spectrum active ingredients that effectively filter out radiation in the pre-vitamin D3 absorbance range.

Urocanic acid acts as a natural, endogenous sunscreen or photoprotectant against UVB-induced DNA damage in humans. Urocanic acid is found predominantly in the stratum corneum of the skin. When exposed to UVB Irradiation, naturally occurring trans-urocanic acid is converted to the cis isomer, which is known to activate suppressor T cells. The absorbance spectrum of trans-urocanic acid is high in the <NUM> to <NUM> range, and moderate in the <NUM> to <NUM> range.

The photochemical properties of natural skin melanin (eumelanin and pheomelanin) make it an excellent photoprotectant, as it absorbs UV radiation over a wide spectrum that includes the <NUM> to <NUM> range.

Following exposure to UV radiation, the skin's stratum corneum thickens by as much as three times in a process termed epidermal hyperplasia, and is associated with increased tolerance to subsequent exposure. In another positive contributing factor to the current invention's safety profile; these thick cell layers absorb, reflect and scatter radiation.

As a general rule, the longer the wavelength of radiation, the deeper the Penetration into the skin. Wavelengths in the <NUM> to <NUM> range generally penetrate no deeper than the epidermis.

The UV filters which are considered appropriate for the current invention are basically UVA blockers, but some, such as Homosalate, Octisalate and Sulisobenzone, also offer mild to moderate protection in the <NUM> to <NUM> range.

One surprising discovery of the current invention is that from a standpoint of protection from UVB radiation, Avobenzone's ability to absorb radiation in the <NUM> to <NUM> range actually increases over time. Since the sunscreen composition according to the present invention comprises <NUM> wt. % to <NUM> wt. % of avobenzone, this means that as the sunscreen user spends more time under the sun (i.e. after sufficient vitamin D production has occurred) Avobenzone begins providing better coverage in the <NUM> to <NUM> range.

"Inactive" ingredients can be a misnomer in that they provide UVB protection in minimal amounts. For example, Polycrylene and Octofluorene can be added to the formulation principally to photostabilize Avobenzone, but in doing so provide some UVB protection.

An unanticipated and surprising advantage of the current invention is that as the vitamin D precursor <NUM>,<NUM>(OH)2D3 is produced by the body as a result of invention's formulation, that very <NUM>,<NUM>(OH)2D3 protects primary human keratinocytes against UVB-induced DNA damage.

DNA's absorbance spectrum shows high absorption between <NUM> and <NUM>, moderate absorbance between <NUM> and <NUM> and low to zero absorbance between <NUM> and <NUM>. In terms of the current invention's sunscreen formulations, those wavelengths permitted to penetrate the skin are generally in the <NUM> to <NUM> range, a range poorly absorbed by DNA and RNA.

The proper application of a sunscreen is important when it comes to blocking radiation. It has been observed that lower sunburn protection factor (SPF) formulations tend to be used more regularly and applied more generously than higher SPF formulations. This may be the case because SPF formulations with lower concentrations of UV filters are less oily, less occlusive, and have a lighter, less greasy feel to the skin than higher SPF formulations. Preferred embodiments of the current invention call for lower SPF concentrations. One surprising health benefit of the current invention is that people who properly apply (and re-apply) lower SPF sunscreens are in many cases actually blocking radiation in a safer, less spotty way than people who improperly apply higher SPF formulations.

Research has shown that vitamin D has significant protective effects against the development of cancer because it regulates cells growth, cell differentiation and cell death. Vitamin D works by binding to a receptor in cells. Researchers in Italy identified a possible link between melanoma and a gene involved in vitamin D metabolism. (<NPL>) Genetic differences in the vitamin D receptor gene Bsml mean that people may have different levels of vitamin D in their bodies, and some people may have more vitamin D-related protection against cancer than others. According to the study's authors, these findings indirectly support the hypothesis that sun exposure might have an anti- melanoma effect through activation of the vitamin D System.

The above safety considerations of the current invention's formulations are surprising improvements over broad-spectrum sunscreen formulations.

It is a contention of the current invention that prior art teachings and expectations regarding direct sunlight are flawed and at best imperfect; and that the current invention provides a surprising and unanticipated improvement over all of this art.

Some formulations of the current invention exclude active ingredients (UV filters) which block a high percentage of those wavelengths of UV radiation used by the body to manufacture vitamin D and include active ingredients which permit the passage of a high percentage of the UV radiation used to manufacture vitamin D. In essence, some embodiments of the current invention anticipate an optimal balance of providing protection from the negative effects of solar radiation or tanning bed radiation while permitting a sufficient amount of vitamin D production by the body, thus providing the best of both worlds.

The amplitudes (heights of the absorbance curves) which measure the degree to which a UV filter absorbs UV and the breadths (widths of the absorbance curves) which reflect how broadly effective a UV filter is across the UV spectrum were examined for various UV filters. Only those UV filters with amplitudes and breadths that permit a reasonable amount of UV radiation in vitamin D producing range enter the skin were considered appropriate for inclusion in the current invention's formulations.

The composition of the present invention comprises avobenzone from <NUM> wt. % to <NUM> wt. %, terephthalylidene-<NUM>,<NUM>'-dicamphor-<NUM>,<NUM>'-disulfonic acid <NUM> wt. % to <NUM> wt. %, octocrylene <NUM> wt. % to <NUM> wt. %, oxybenzone <NUM> wt. % to <NUM> wt. %, octisalate <NUM> wt. % to <NUM> wt. %, sulisobenzone <NUM> wt. % to <NUM> wt. %, homosalate <NUM> wt. % to <NUM> wt. % and meradimate <NUM> wt. % to <NUM> wt.

In one combination of the invention, Sulisobenzone, Homosalate and Octisalate are each used in lower concentrations (<NUM> percent or less because they absorb minimal UVB radiation); and Avobenzone in a higher concentration (<NUM> to <NUM> percent, the maximum permitted by law).

In another combination, Homosalate and Octisalate are each used in lower concentrations (<NUM> percent or less because they absorb minimal UVB radiation); and Avobenzone in a higher concentration (<NUM> to <NUM> percent, the maximum permitted by law).

In another combination, Homosalate and Octisalate are each used in lower concentrations (<NUM> percent or less because they absorb minimal UVB radiation); Avobenzone in a higher concentration (<NUM> to <NUM> percent, the maximum permitted by law) and Ecamsule in a higher concentration (<NUM> to <NUM> percent, the maximum permitted by law).

Aspects of some embodiments of the current invention thereby teach away from the long-established mantra of "broad-spectrum" sunlight blocking and achieve surprising and valuable benefits. Some aspects of the current invention describe a safe, user-friendly and pragmatic solution to the problem of preventing vitamin D production in the skin by broad-spectrum sunscreens.

The appropriate UV filters considered acceptable for inclusion in examples of the current invention's formulations, either alone or in combination with any number of other appropriate UV filters, include, but are not limited to, the following examples of UV filters which absorb little or no UV radiation in the vitamin D producing range:.

The examples of UV filters (i.e. active sunscreen ingredients) that are included as appropriate active ingredients are herein meant to be representative and certainly the current invention contemplates the inclusion of any molecule based on its ability to fully or partially permit the passage into the skin of UV radiation in approximately the <NUM> to <NUM> range.

Note that the terms "excluded" and "inappropriate for inclusion" used herein are intended to mean that there is <NUM> percent concentration, or that there is some small, trace, substantially ineffective amount present - with examples including less than <NUM>% (wt. ), less than <NUM>% (wt. ), less than <NUM>% (wt), less than <NUM>% (wt), or less than <NUM>% (wt). The inappropriate UV filters which are to be excluded from the current invention's formulations, include, but are not limited to, the following UV filters demonstrating a high percentage of the UV radiation absorption in the vitamin D producing range: Benzophenone (<NPL>); <NUM>,<NUM>-Dihydroxybenzophenone (Benzophenone-<NUM>, <NPL>); <NUM>,<NUM>',<NUM>,<NUM>'-Tetrahydroxybenzophenone (Benzophenone-<NUM> or Uvinul D <NUM>, <NPL>); <NUM>,<NUM>'-Dihydroxy-<NUM>,<NUM>'-dimethoxybenzophenone (Benzophenone-<NUM>, <NPL>); <NUM>,<NUM>'-Dihydroxy-<NUM>-methoxybenzophenone (Benzophenone-<NUM>, Dioxybenzone, <NPL>); <NUM>-Hydroxy-<NUM>-(Octyloxy)Benzophenone (Benzophenone-<NUM>, Octabenzone,<NPL>); <NUM>-Methylbenzylidene camphor (also known as <NUM>-MBC, Uvinul MBC <NUM>, Enzacamene, Eusolex <NUM>, Parsol <NUM> or <NUM>-(<NUM>-methylbenzyliden)camphor, <NPL>); Cinoxate (also known as <NUM>-ethoxyethyl p-methoxycinnamate, <NPL>); Octinoxate (also known as octyl methoxycinnamate, CMC, Uvinul MC <NUM>, Neo Heliopan AV, Parsol MCX or ethylhexyl methoxycinnamate,<NPL>); Diethanolamine p-methoxycinnamate (also known as Diethanolamine methoxycinnamate or DEA methoxycinnamate, <NPL>); Isoamyl p-methoxycinnamate (also known as, Isopentenyl-<NUM>-methoxycinnamate, IMC, Neo Heliopan E1000 or Amiloxate, <NPL>); Dibenzoylmethane (also known as dibenzoyl methane, <NPL>); Bisoctrizole (also known as Tinosorb M, methylene bis-benzotriazolyl tetramethylbutylphenol or MBBT, <NPL>); Zinc oxide (also known as ZnO); Titanium dioxide (also known as titanium (IV) oxide, TiO2 or titania); Cerium(IV) oxide (also known as ceria, cerium oxide or CeO2); Ensulizole (also known as phenylbenzimidazole sulfonic acid, phenylbenzimidazole, <NUM>-phenylbenzimidazole-<NUM>-sufonic acid, PBSA, Parsol HS, <NPL>); Aminobenzoic acid (also known as <NUM>-aminobenzoic acid, p-aminobenzoic acid or PABA, <NPL>); Padimate-<NUM> (otherwise known as Padimate O, Ethylhexyl dimethyl PABA, <NUM>-ethylhexyl <NUM>- dimethylaminobenzoate, Escalol <NUM>, octyl dimethyl PABA or OD-PABA, <NPL>); Padimate-A (also known as amyl p-dimethylaminobenzoate, amyl paradimethylaminobenzoate or amyl dimethyl PABA, <NPL>. ); Glyceryl Aminobenzoate (also known as glyceryl p-aminobenzoate, glyceryl PABA, glyceryl <NUM>-(<NUM>-aminobenzoate), monoglyceryl ester or Lisadimate, <NPL>); Ethylhexyl Triazone (also known as Octyl Triazone, ethylhexyl triazone, Uvinul T <NUM> or ET, <NPL>); Troiamine Salicylate (also known as triethanolamine salicylate or TEA salicylate, <NPL>); Drometrizole Trisiloxane (also known as DTS, Mexoryl XL, <NPL>); Bemotrizinol (also known as Tinosorb S, bis-ethylhexyloxyphenol methoxyphenyl triazine, bis(ethylhexyloxyphenol methoxyphenol) triazine, BEMT or Anisotriazine, <NPL>); Iscotrizinol (also known as Uvasorb HEB, diethylhexyl butamido triazone, dioctyl butamido triazone or DBT, <NPL>); and Digalloyl trioleate (otherwise known as <NUM>-(<NUM>,<NUM>-Dimethyl <NUM> norbornyliden)-3penten-<NUM>-one, <NPL>). Because of their absorption in the vitamin D producing range the compounds of the formula I as described in <CIT> are also inappropriate as ingredients in the current invention.

The examples of UV filters that are excluded as inappropriate active ingredients (noting again that some small, trace and ineffective amount may be present) are herein meant to be representative and certainly the current invention contemplates the exclusion of any molecule based on its ability to fully or amply block the passage into skin of UV radiation in approximate the <NUM> to <NUM> range. Other UV filters are listed as substances in the CTFA International Cosmetic Ingredient Dictionary, or are approved by the appropriate regulatory agencies in Australia, Canada, China, EU, Japan, Sweden, The Netherlands, UK or USA; or are cleared by the US Cosmetic Ingredient Review (CIR) group, all of which are which is incorporated in the current invention by way of reference.

The following representative examples of ingredients may or may not be selected as appropriate for inclusion in the present invention, with one determining factor being an absorbance curve with an amplitude and breadth that permit sufficient radiation in the vitamin D producing range (approximately <NUM> to <NUM>) to enter the skin thereby producing a healthful, disease-opposing amount of vitamin D: <NUM>-(<NUM>-Hydroxy-<NUM>-methyl-phenyl)Benzotriazole (Drometrizole, <NPL>); <NUM>-Hydroxy-<NUM>-methoxybenzophenone-<NUM>-sulfonic Acid, Monosodium Salt (Benzophenone <NUM>, <NPL>); <NUM>-Hydroxyethyl salicylate (CAS #: <NUM>-<NUM>-<NUM>); <NUM>-Benzylidene camphor, (also known as 3BC, <NPL>); <NUM>-[<NUM>-(<NUM>-diethylaminophenyl)-<NUM>-oxoethyl]thiazolium salt; <NUM>-Chloro-<NUM>- hydroxybenzophenone (Benzophenone-<NUM>, <NPL>); Aesculetin (also known as esculetin, <NUM>,<NUM>-dihydroxycoumarin and cichorigenin); Artemia salina Plankton extract, Benzophenone-<NUM> (also known as Benzenesulfonic acid, <NPL>); Benzyl salicylate (<NPL>); Benzylidene Camphor Sulfonic Acid <NPL>); Beta, <NUM>-glucopyranoxy propyl hydroxy benzophenone; Bis(<NUM>,<NUM>-ihydroxyphenyl)Methanone (Benzophenone-<NUM>, Benzophenone-n, Uvinul M <NUM>,<NPL>); Bornelone (<NPL>); Broccoli sprout extracts including sulforaphane; brown algae polyphenols (BAPs), Camphor benzalkonium methosulfate, (also known as Mexoryl SO, <NPL>); Dibenzoylmethane (<NPL>); Dibenzylideneacetone (also known as dibenzalacetone or dba); Dihydroxyacetone; Diisopropyl methyl cinnamate (<NPL>); Dimethicodiethylbenzal malonate; Dimethoxyphenyl-[<NUM>-(<NUM>,<NUM>)]-<NUM>,<NUM> dimethyl <NUM>,<NUM> pentanedione; Dipropylene glycol salicylate; Diurethane dimethacryiate (<NPL>); Endocannabinoids; Ethyl <NUM>-cyano-<NUM>,<NUM>- diphenylacrylate (Etocrilene, <NPL>); Ethyl <NUM>-[bis(hydroxyl propyl)] aminobenzoate (also known as propoxylate of p-aminoethylbenzoate or Roxadimate, <NPL>); Ethyl Cinnamate (<NPL>); Ethyl dihydroxypropyl PABA; Ethyl Diisopropylcinnamate (<NPL>); Ethyl Methoxycinnamate (<NPL>); Ethyl PABA (also known as benzocaine); Ethyl Urocanate (<NPL>); Ethylhexyl dimethoxy benzylidene dioxoimidazoline propionate; Ferulic acid; Forskolin; Glyceryl ethylhexanoate dimethoxycinnamate; Glyceryl octanoate dimethoxycinnamate; Isopropylbenzyl Salicylate (<NPL>); Isopentyl trimethoxycinnamate trisiloxane; Isopropyl methoxycinnamate(<NPL>); Lawsone; Magnesium aluminum silicate, Menthyl salicylate (<NPL>); p- Aminobenzoic Acid, <NUM>,<NUM>-dihydroxy-N-(<NUM>-hydroxypropyl)-<NUM>,<NUM>-dimethylbutanamide ester; Petrolatum jelly (<NPL>);Phenylbenzimidazole; Phenylbenzimidazole Tea sulfonate (<NPL>); Polyacrylamido methylbenzylidene camphor <NUM><NPL>); Quicksun Clear and Quicksun Matte extracts; Salicylic acid; Sodium Phenylbenzimidazole sulfonate (<NPL>); Sorbohydroxamic acid; Umbelliferone (also known as <NUM>- hydroxycoumarin); and Urocanic Acid (<NUM>-Imidazoleacrylic acid, <NPL>) and each of their respective metabolites, acids, hydroxyl groups, esters, salts, alcohols, acyl groups, related chemical species, or pharmaceutically-acceptable salts thereof.

Additional organic screening agents may be selected for said inclusion especially from: the anthranilates, benzylidenecamphors, benzimidazoles, benzotriazoles, cinnamates, dibenzoylmethanes, imidazolines, PABAs, salicylates, triazines and nucleic acids including DNA and RNA.

In addition to the specific examples of UV filters provided as appropriate or inappropriate for inclusion in the present invention's formulations are each of their respective metabolites, acids, hydroxyl groups, esters, salts, alcohols, acyl groups, related Chemical species, or pharmaceutically-acceptable salts thereof.

There are various factors that one must consider when selecting the appropriate active and inactive ingredients for the current invention, remembering always that the guiding light in that decision is always a balance between making it possible for the body to manufacture an adequate amount of vitamin D and preventing excessive adverse effects to the skin from the sun. Those factors involved in the selection of appropriate ingredients include, but are not limited to, the following. Study reports presenting the UV radiation absorbance ranges and maxima (i.e. molar absorbance coefficients) for the active ingredients, inactive ingredients and vitamin D production can vary depending upon which solvent medium (e.g. water, methanol, acetonitrile, n-hexane) is used when the molecule's spectral data is collected, the type of the spectrophotometric measurements, the calibration of the Instrumentation, pollutants in the samples, the pH of the samples, water-in-oil, oil-in-water, the examination in vivo or in vitro, the concentration of the molecule, the length of time the molecule was been exposed to radiation, the presence or absence of other molecules, the intensity of radiation to which the active ingredient has been exposed, the degradation of the molecule, skin types, the presence or absence of SPF boosters such as glass beads, UV-Pearls and microcapsules or ingredients to improve photostability such as antioxidants and Triplet-Triplet Quenches, and the Interpretation of the data. The current invention acknowledges that not all people applying sunscreen apply it as thickly as others, and that generally the thicker it is applied, the better the UV protection. It has been reported that sunscreen users on average apply a layer of sunscreen that is only one forth of the recommended thickness. Generally the thickness is measured in layers <NUM>, <NUM> and <NUM>/cm<NUM> deep. This thickness question could affect the inclusion or exclusion decision. Such differences could conceivably influence the decision to include or exclude the UV filter candidate, any such change from the inclusionary list to the exclusionary list (or vice-versa) is contemplated by the current invention without detracting from the essence. For example, shifts in the absorbance curves for oxybenzone, TDSA and Bisdisulizole disodium have been reported as a result of the base (TEA or NaOH) used to neutralize the sample.

The concentrations of each of the active ingredients in the current invention can vary, resulting in SPF numbers from <NUM> to <NUM> plus reflecting the product's ability to protect from sunburn (erythema) and low, medium, high or highest "Star" (or other rating) to reflect its ability to block UVA radiation; the essential being that the concentrations permit the synthesis of at least a health- promoting amount of vitamin D.

In addition to sunscreens, whose primary purpose is medicinal sunscreening (preventing UV radiation from harming the skin), the current invention can be applied to making the therapeutic claim of not preventing vitamin D production in cosmetic products including but not limited to hair Products, lip balms, creams, lotions, sprays, insect repellants and make-up which often also include a UV filter.

There are wavelengths of radiation other than approximately <NUM> to <NUM> (those in the vitamin D range) which can be beneficial to the body as well. Depending on the formulation, the current patent can include or exclude active ingredients in order to permit other health-enhancing wavelengths to enter the skin.

A vitamin D enhancing sunscreen with a formulation as per the current invention is applied to the skin first, and then, if the sunscreen user desires to remain in the sun for an extended exposure (i.e. long enough to potentially induce erythema), the person may then apply a second or third coat of sunscreen which contains UVB blocking ingredients herein defined as inappropriate for vitamin D production. The result being that by the time of the second application, the body will have already produced sufficient vitamin D for proper health for the day. The period of time before applying the second sunscreen should be sufficient to allow an effective amount of Vitamin D to be absorbed. Examples include at least about <NUM> minutes, at least about <NUM> minutes, at least about <NUM> minutes, and at least about <NUM> hour.

In one embodiment, a vitamin D enhancing sunscreen with a formulation as per the current Invention is applied to certain areas of the body at the same time as an additional sunscreen which has UVB blocking ingredients (and perhaps other inactive ingredients such as moisturizers) herein defined as inappropriate is applied to other areas. For example, a sunscreen user may wish to use a sunscreen with inappropriate ingredients on his or her face at the same time as a sunscreen with only appropriate ingredients on his or her arms and legs.

The current invention may be specially formulated for use on humans of different ages, with increased vitamin D production especially preferred in the elderly, and certain considerations such as waterproof for children.

The current invention may be formulated for use on domestic animals such as horses, dogs and cats; and on farm animals. Increasing vitamin D levels in farm animals such as cows, pigs and goats provides health benefits to the farm animals and, surprisingly, increases the vitamin D content of their milk and meat, a health benefit to the humans who consume them.

Some embodiments of the present invention are for adults, others for children and embodiments may be formulated as a lotion, cream, gels, oil, spray, emulsion, solution, moisturizer, ointment, transdermal delivery system for other molecules, make-up, foundation, shampoo, soap, spray, stick, or.

lip balm; can be made sticky, non-sticky, waterproof, water resistant, abrasion resistant or rub-proof, rinse-off, or leave-on; and can contain humectants, emulsifiers, emollients, preservatives and thickeners. Other sunscreen ingredients may include anti-irritants, and products which help cell communication (signaling), and which mimic the structure and function of the skin.

The antioxidants or free-radical scavengers that may be used in the composition according to the invention comprise, besides certain anti-pollution agents mentioned above, vitamin E and its derivatives such as tocopheryl acetate; vitamin C, panthenol (provitamin B5), retinyl palmitate (vitamin A palmitate), bioflavonoids; coenzyme Q10 or ubiquinone; certain enzymes, for instance catalase, Superoxide dismutase, lactoperoxidase, glutathione peroxidase and quinone reductases; glutathione; benzylidenecamphor; benzylcyclanones; substituted napthalenones; pidolates; phytanetriol; gamma-oryzanol; lignans; and melatonin as well as all of their respective salts, analogues and metabolites.

In one embodiment, Spectrasolv technology is used to formulate the dielectric constant of the oil phase to that at which Avobenzone is made most stable. In one preferred embodiment, Avobenzone is photostabilized with Octofluorene by Hallstar or other manufacturer. At use levels of <NUM> to <NUM> percent, Octofluorene absorbs UV radiation in such minimal amounts as not to affect SPF or vitamin D synthesis, and its absorbance spectrum fits well in that most of its absorption is in the UVA range. In one preferred embodiment, Avobenzone is photostabilized and made water resistant with Polycrylene (INCI Name: Polyester-<NUM> and <NPL>) by Hallstar or other manufacturer. At use levels of <NUM> to <NUM> percent, Polycrylene absorbs UV radiation in such minimal amounts as not to affect SPF or vitamin D synthesis. Polycrylene also improves the substantivity of sunscreen formulations as measured by resistance to wash-off. In one preferred embodiment, Avobenzone is photostabilized using Hawaiian Tropic's SunSure proprietary combination of ingredients.

In addition to the particular molecules presented in lists of UV filters (both appropriate and inappropriate); the current patent contemplates the inclusion or exclusion of their respective metabolites, acids, hydroxyl groups, esters, salts, alcohols, acyl groups, pharmaceutically acceptable carriers, and other related Chemical species thereof.

In one preferred embodiment, a UV booster for organic sunscreen actives such as the citrate ester Trimollient BC (INCl: Tris PPG-<NUM> benzyl citrate) provides benefits in sun protection.

Some ingredients which are somewhat erroneously referred to as "inactive" ingredients in sunscreens, for example unrefined shea butter, coconut oil and other oils, are known to have mild UV blocking properties. The following ingredients, (with others possible in keeping with the vitamin D enhancing teachings of the current invention), may or may not be included in the formulation of the current invention based partially on their absorbance or non-absorbance of radiation in the range that produces vitamin D: Acrylates; C10-<NUM> alkyl acrylate crosspolymer; alcohol (ethyl-, isobutyl-, isopropyl-, methyl-, prop-, and butyl- alcohol or other alcohols), aliantoin; allantoin-p-aminobenzoic acid complex p- aminobenzoic acid; aluminum; aloe vera leaf juice; aloe vera; aloe barbadensis leaf juice; alumina; amyl acetate; amyl dimethyl PABA; amyl para- dimethylaminobenzoate; amyl-p-dimethylaminobenzoate; antibacterial agents; antifungal agents; antioxidants; aromatic amino acids (such as phenylalanine; tryptophan; and tyrosine); ascorbyl palmitate; Baobab pulp; beeswax; benzyl alcohol; BHA; BHT; <NUM>-bromo-<NUM>-nitropropane-I;<NUM>-diol; buffers such as PBS or HEPES; borage seed oil; carrot oil; camphor; caprylic/capric triglyceride; Carbomer <NUM>; carboset; cellulose gum; cetyl alcohol; cetyl palmitate; cetyl stearyl glycol; cetearyl alcohol; cetyl alcohol; cetyl PEG/PPG-<NUM>/<NUM> dimethicone; cinoxate citric acid; clove oil; co-enzyme Q10; cocoa butter; coconut oil; Collagen; colorants; controlled release agents; Coolact <NUM> (INCl: Menthoxypropanediol); creatine; dasheen root extract; dielectric spheres; dihydroxyacetone (self-tanning ingredient); diazolidinyl urea; dibutyl adipate; disodium EDTA; dimethicone; <NUM>-(<NUM>;<NUM>-dimethyl-<NUM>-norbornyliden)- <NUM>-penten2-one; <NUM>;<NUM>-dimethylphenyl-g lyoxylic acid sodium salt; dimethyl polysiloxane; dipropylene glycol salicylate; DMSO; dyes; edelweiss; elastin; emollients; Emu oil; Emulium Kappa; ethyl alcohol; <NUM>- ethylhexyl <NUM>-phenylbenzophenone-<NUM>-carboxylic acid; ethylhexyl palmitate; ethylenediamine; eucalyptus leaf oil; ferulic soy glycerides (FSG); fruit extracts (such as guava; mango; papaya; passionflower); FD&C yellow No.<NUM>; FD&C red No.<NUM>; fragrances; galactoarabinan; glycerin; glyceryl PABA; glyceryl stearate; hemp seed oil; hydroxyacetone (self-tanning ingredient); isohexadecane; isopropyl myristate; isopropyl palmitate; jojoba oil; kukui nut (seed) extract; lanolin; lanolin alcohol; lanolin derivatives; lanolin oil; lawsone (<NUM>-hydroxy-<NUM> ;<NUM>- naphthoquinone); magnesium aluminum silicate; menthol; metallic pigments; microcapsules such as UV-Pearls; microcrystalline titanium coated mica platelets; microcrystalline wax; mircospheres; mineral oil; neopentyl glycol; oleth- <NUM>; oleth-<NUM>-phosphate; C30-<NUM> olefin/isopropyl maleate/MA copolymer; ozokerite; panthenol; parabens (ethyl-; isobutyl; isopropyl-; methyl-; prop-; and butyl- propylparabens); Padina extract; paraffin; PEG <NUM> stearate; PEG-<NUM>; penetration enhancers (such as terpenes and terpenoids); perfumes; petrolatum; Phenoxyethanol; phenoxyethanol; <NUM>-phenylbenzimidazole; photostability improvers such as Corapan TQ (diethylhexyl <NUM>;<NUM>-naphthalate) and Triplet-Triplet Quenches; polymers (including polymers to assist in dispersion and rheology); propylene glycol; polyoxyl-<NUM>-stearate; plumeria extract; polysorbate <NUM>; propellant <NUM>; propellant <NUM>/<NUM>; propoxylate of p-aminoethylbenzoate; propylparaben; propylene glycol; propylene glycol stearate; proteins (such as proteins which are rieh in aromatic amino acids such as keratin and albumin); Quaternium <NUM>; red petrolatum; retinoic acid; retinol; rice extract; rose petal extract; safflower seed oil (Hydresia); SD alcohol <NUM>; SPF boosters such as glass beads; sesame oil; shea butter; silaca sodium carbomer; sodium ascorbyl phosphate; sodium cetearyl sulfate; sodium citrate; sodium Chloride; sodium hydroxide; sorbitan oleate; sorbitan stearate; sorbitol; stabilized aloe vera gel; stearic acid; stearyl alcohol; stearyl hydrogenated dimmer dilinoleate copolymer; ; sunflower oil; synthetic spermaceti; theobroma cocao (cocoa) seed butter; tocopheryl acetate; triethanolamine stearate; vitamins such as A; C; E; D; B3; B6; B12; water; watermelon (Citrullus lanatus); wax; wheat (triticum vulgare); wolfberry (goji berry); germ oil; X-Tend™ <NUM> (a polar ester with high-solubilizing capacity for Oxybenzone and Avobenzone); xanthan gum; and each of their respective metabolites, acids, hydroxyl groups, esters, salts, alcohols, acyl groups, related Chemical species, or pharmaceutically-acceptable salts thereof.

Claim 1:
A sunscreen composition suitable for providing protection against ultraviolet radiation contains at least three active ultraviolet radiation filter through which ultraviolet B radiation is permitted to enter the skin in an amount sufficient for the body to produce a healthful and disease-opposing quantity of vitamin D<NUM> and chemical precursors thereof, wherein the composition comprises avobenzone from <NUM> wt.% to <NUM> wt.%, terephthalylidene-<NUM>,<NUM>'-dicamphor-<NUM>,<NUM>'-disulfonic acid <NUM> wt.% to <NUM> wt.%, octocrylene <NUM> wt.% to <NUM> wt.%, oxybenzone <NUM> wt.% to <NUM> wt.%, octisalate <NUM> wt.% to <NUM> wt.%, sulisobenzone <NUM> wt.% to <NUM> wt.%, homosalate <NUM> wt.% to <NUM> wt.% and meradimate <NUM> wt.% to <NUM> wt.%.