Regulation of Sunscreens

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Regulation of Sunscreens

Sunscreens, typically a lotion, spray, gel or other topical product, absorbs or reflects some of the sun's ultraviolet (UV) radiation on the skin exposed to sunlight. Sunscreen ingredients help to prevent sunburn and may reduce the chance of premature skin aging, skin cancer, and other harmful effects due to the sun.

Consequently, a product that includes the term “sunscreen” in its labeling or in any other way represents or suggests that it is intended to prevent, mitigate or treat the effects of solar radiation comes within the definition of a drug according to the the US Food and Drug Administration (FDA).

The regulatory requirements for drugs are more extensive than the requirements applicable to cosmetics. For example, the FD&C Act requires that drug manufacturers register every year with the FDA and update their lists of all manufactured drugs twice annually. Additionally, drugs must be manufactured in accordance with current good manufacturing practice regulations.


	What a Drug Status Means

	FDA Registration: Sunscreen manufacturers must register with the FDA, work under GMP guidelines, and update their list of drugs twice annually. Labeling rules: All sunscreen ingredients must be listed separately in the ingredient list under "active ingredients" together with the concentration used in the product. Validation of claims: Claims made on the label suggesting that the product offers sun protection (UVA and/or UVB) must be substantiated with clinical and/or in-vitro testing

FDA Allowable UV Filters

There are two types of sunscreens: organic (or chemical) and inorganic (or physical) sunscreens. Organic sunscreens are usually aromatic molecules conjugated with carbonyl groups which allow the molecule to absorb high-energy, skin-damaging UV rays and release the energy as lower-energy harmless rays.

Inorganic sunscreens such as titanium dioxide and zinc oxide do not absorb but reflect UV rays. Micronized titanium dioxide and zinc oxide, however, also have the ability to absorb UV rays. Inorganic sunscreens reflect primarily UVB rays. However, the larger the particle size the more UVA protection is also achieved.


UV Filter	Max. Level* (alone/combined)	UV Protection

p-Aminobenzoic acid	15% / 5-15%	UVB
Padimate O	8%	UVB
Phenylbenzimidazole sulfonic acid (Ensulizole)	4% / 1-4%	UVB
Cinoxate	3% / 1-3%	UVB
Dioxybenzone (benzophenone-8)	3% / 3%	UVB/UVA
Oxybenzone (benzophenone-3)	6% / 2-6%	UVB/UVA
Homosalate	15% / 4-15%	UVB
Menthyl anthranilate	5% / 3-5%	UVA
Octocrylene	10% / 7-10%	UVB
Octyl methoxycinnamate	10% / 2-7.5%	UVB
Octyl salicylate	5% / 3-5%	UVB
Sulisobenzone (benzophenone-4)	10% / 5-10%	UVB/UVA
Trolamine salicylate	12%	UVB
Avobenzone	3%	UVB/UVA
Ecamsule	10%	UVA
Titanium dioxide	25% / 2-25%	UVB
Zinc oxide	25% / 2-25%	UVB/UVA

* Maximum levels refer to the USA

Measuring & Labeling UVB Protection (SPF)

SPF (Sun Protection Factor) is a quantitative measure of the effectiveness of a sunscreen to prevent sunburn. It is determined by assessing individual sensitivity to sunburn by solar-stimulated radiation with or without sunscreen. Wearing a sunscreen with SPF 30 means that the skin will not burn until it has been exposed to 30 times the amount of solar energy that would normally cause it to burn.

The SPF is typically measured in-vivo where sunscreen is applied to volunteers. There is also an in-vitro method available which typically agrees very well with in-vivo measurements. However, the FDA still requires in-vivo testing for SPF determination.


	In-vivo SPF test: The SPF is measured by applying sunscreen to the skin of a volunteer and measuring how long it takes before sunburn occurs when exposed to an artificial sunlight source. The FDA has proposed guidelines to standardize the test procedure, including the number of tested subjects, skin type, site of testing, light source, control sunscreen, and mode of application. In-vitro SPF test: Using a specially designed spectrometer, the actual transmittance of the sunscreen is measured along with the degradation of the product caused by sunlight exposure. The transmittance of the sunscreen is measured over the entire UVB range (290–320 nm) along with a table of how effective various wavelengths are in causing sunburn (the erythemal action spectrum) and the actual intensity spectrum of sunlight. SPF Labeling: So far, the FDA allowed SPF values up to 30, but not higher. Products with SPF values greater than 30 had to be labeled with the collective term ‘‘30+’’. In 2007, the FDA has proposed to increase the SPF value to 50 and revise the collective term to ‘‘50+’.’ In addition, the FDA has proposed to change the term "sun protection" to "sunburn protection" and to add the term "UVB" to the term "SPF". A properly labeled sunscreen offering only UVB protection would read like "Sunburn Protection with UVB SPF 35".

Measuring & Labeling UVA Protection

Until a few years ago, UVB rays (290-320 nm) were considered the most important contributor to skin damage. New studies have now shown that primarily UVA rays (320-400 nm) are involved in skin tumor development, suppression of immune function and premature aging. In addition, UVA rays comprise 95% of solar radiation and penetrate much deeper into the skin than UVB rays.

Therefore, it has now been recognized that UVA protection is as important as UVB protection. Sunscreens that offer both UVA and UVB protection are also called "broad-spectrum sunscreens" as they cover the entire solar UV spectrum from 290nm to 400nm. UVA protection is measured by an in-vivo and in-vitro test.


	In-vivo UVA test (Persistent Pigment Darkening, PPD): The PPD test is a laboratory evaluation on human subjects that yields the ratio of the UVA dose required to produce a very light skin darkening response, with and without a sunscreen product on the skin. The PPD test produces rapid (2-4h) and reproducible results with moderately low doses of UVA. The resulting UVA-PF (protection factor) is categorized as follows: - 1 star (low): PF 2 - 4 - 2 stars (medium): PF 4 - 8 - 3 stars (high): PF 8 - 12 - 4 stars (highest): PF > 12 In-vitro UVA test (UVA Transmittance Test): The in-vitro test requires applying 2 mg/cm2 of product on a quartz plate, irradiating with a specified UV dose from a solar simulator and then measuring the fraction of the applied UV dose transmitted through the sunscreen film at 5 nm wavelength intervals from 290 nm to 400 nm. The measurement is made after irradiation with 2/3 the labeled SPF in MEDs (1 MED = 20 effective mJ/cm2). - 1 star (low): Ratio = 0.20 - 0.39 - 2 stars (medium): Ratio = 0.40 - 0.69 - 3 stars (high): Ratio = 0.70 - 0.95 - 4 stars (highest): Ratio > 0.95 Labeling: As outlined in the Monograph Amendment of 2007, the FDA has proposed that sunscreen products that make any claims for UVA protection must be tested and that both the in-vivo and the in-vitro tests must be performed and the lower rating of the two methods is used. Products that contain UVA filters but are not tested must state on the label ‘‘No UVA Protection". The FDA is aware that the UVA ratings are very stringent, and achieving a 4 star rating will be a significant challenge for manufacturers.

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