The sun does not recognize borders, unlike regulations. While the European Union allows 28 UV filters, the United States only offers 16 and has not approved any new filters for over twenty years. How can we explain this difference? What is the impact for American consumers? Let's delve into this topic together.
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Sunscreen Filters: What Does the Regulation Say in the United States?
Summary
- How is sunscreen regulated in the United States?
- What are the UV filters authorized in the United States and the European Union?
- Sources
Published May 5, 2025,
updated on May 5, 2025,
by
Pauline, Chemical Engineer
—
10 min read
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How is sunscreen regulated in the United States?
More than a cosmetic routine, sun protection is a significant public health issue. With over 3 million skin cancer cases diagnosed each year in the United States, nearly 90% of which are linked to UV ray exposure, Americans are among the most affected. Yet, in the United States, the range of UV filters available for formulating sunscreens has remained stagnant since the 1990s. This apparent paradox is largely due to the specific legal status of sunscreens on American soil.
Unlike the European Union, where UV filters are governed by the cosmetic regulation, specifically by Regulation (EC) No 1223/2009 of the European Parliament and Council, the United States categorizes sunscreens as "over-the-counter (OTC)" drugs, which are medications available without a prescription. This means that these ingredients are subject to the same regulatory requirements as drugs and must adhere to similar manufacturing, efficacy, and safety standards. The approval of a new UV filter by the Food and Drug Administration (FDA), the agency with the power, among other things, to authorize or prohibit the marketing of drugs on American territory, is thus a lengthy and costly process, not compatible with the pace of cosmetic innovation.
This regulatory framework also defines which ingredients are recognized as "Generally Recognized As Safe and Effective", or GRASE, meaning they are safe and effective. A UV filter that is not classified as GRASE cannot be used. The only downside is that the GRASE list of sunscreens has hardly changed since 1999. An attempt to modernize was made in 2021, when the FDA published an order relating to over-the-counter drug monographs. The goal was to establish the official list of UV filters recognized as GRASE. Of the 16 filters still allowed in the United States to this day, only two mineral filters have achieved this status: zinc oxide and titanium dioxide. More specifically, the following categories were proposed by the FDA.
| UV Filters Recognized as GRASE | UV filters not recognized as GRASE due to safety concerns | UV filters not recognized as GRASE due to the need for additional data |
|---|---|---|
| Zinc Oxide, Titanium Dioxide | PABA, Trolamine Salicylate | Cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, avobenzone |
GRASE categorization of UV filters by the FDA in the United States
Source: U.S. Food and Drug Administration (FDA). Final Administrative Orders for Over-the-Counter Monographs; Availability (2021).
Other chemical filters, including commonly used actives such as avobenzone, octocrylene, or homosalate, are not officially considered safe and effective. They remain usable but in a regulatory gray area : their status is provisional, pending additional toxicological data, particularly on systemic absorption. This caution is at the root of the inertia in the American market regarding UV filters. By requiring data equivalent to that required for a drug, the FDA imposes a scientific and financial burden that is difficult for sunscreen manufacturers to bear, especially when it comes to filters that have been used for several years in other regions of the world with a good track record in terms of tolerance.
This situation puts American brands in a regulatory deadlock: they can neither replace the controversial UV filters, such as the oxybenzone, nor incorporate new, more efficient, more stable, or better tolerated filters.
American consumers are also affected by these regulatory constraints. Although they seemingly have access to a wide range of sun protection products, they are in fact limited in their choices. The near absence of innovative UV filters in the formulas makes it challenging to formulate sunscreens that effectively cover the entire UV spectrum, including UVA, the primary cause of photoaging. The sensory experience of sun protection products also suffers from regulatory requirements, and the textures struggle to be as light and invisible as their European or Asian counterparts. This is not insignificant: an unpleasant texture reduces adherence and therefore protection. There is thus a real need for new UV filters in the United States today.
What are the UV filters authorized in the United States and the European Union?
Currently, 28 sunscreen filters are authorized in the European Union, compared to only 16 in the United States.
| Sunscreen Filter | Regulation in the United States | Regulation in the European Union |
|---|---|---|
| Para-aminobenzoic acid (INCI: PABA) | Authorized up to 15% | Authorized up to 5% |
| Amiloxate (INCI: Isoamyl p-Methoxycinnamate) | / | Authorized up to 10% |
| Anisotriazine (INCI: Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine) | / | Authorized up to 10% |
| Avobenzone (INCI: Butyl Methoxydibenzoylmethane) | Authorized up to 3% | Authorized up to 5% |
| Diethylamino Hydroxybenzoyl Hexyl Benzoate (INCI: Diethylamino Hydroxybenzoyl Hexyl Benzoate) | / | Authorized up to 10% |
| Bisoctrizole (INCI: Methylene Bis-Benzotriazolyl Tetramethylbutylphenol) | / | Authorized up to 10% |
| Bisimidazylate (INCI: Disodium Phenyl Dibenzimidazole Tetrasulfonate) | / | Authorized up to 10% |
| Cinoxate (INCI: Cinoxate) | Authorized up to 3% | / |
| Diethylhexyl Butamido Triazone (INCI: Diethylhexyl Butamido Triazone) | / | Authorized up to 10% |
| Dimethicodiethylbenzalmalonate (INCI: Polysilicone-15) | / | Authorized up to 10% |
| Dioxybenzone (INCI: Benzophenone-8) | Authorized up to 3% | / |
| Titanium Dioxide (INCI: Titanium Dioxide) | Authorized up to 25% | Authorized up to 25% |
| Ecamsule (INCI: Terephthalylidene Dicamphor Sulphonic Acid) | / | Authorized up to 10% |
| Ensulizole (INCI: Phenylbenzimidazole Sulfonic Acid) | Authorized up to 4% | Authorized up to 8% |
| Enzacamene (INCI: 4-Methylbenzylidene Camphor) | / | Authorized up to 4% |
| Ethoxylated Ethyl-4-aminobenzoate (INCI: PEG-25 PABA) | / | Authorized up to 10% |
| Homosalate (INCI: Homosalate) | Authorized up to 15% | Permitted up to 7.34% |
| Meradimate (INCI: Meradimate) | Authorized up to 5% | / |
| Camphor Benzalkonium Methosulfate (INCI: Camphor Benzalkonium Methosulfate) | / | Authorized up to 5% |
| Mexoryl SL (INCI: Benzylidene Camphor Sulfonic Acid) | / | Authorized up to 6% |
| Mexoryl SW (INCI: Polyacrylamidomethyl Benzylidene Camphor) | / | Authorized up to 6% |
| Mexoryl XL (INCI: Drometrizole Trisiloxane) | / | Authorized up to 15% |
| Octinoxate (INCI: Ethylhexyl Methoxycinnamate) | Authorized up to 7.5% | Authorized up to 10% |
| Octisalate (INCI: Ethylhexyl Salicylate) | Authorized up to 5% | Authorized up to 5% |
| Octocrylene (INCI: Octocrylene) | Authorized up to 10% | Authorized up to 10% |
| Octyl Triazone (INCI: Ethylhexyl Triazone) | / | Authorized up to 5% |
| Oxybenzone (INCI: Benzophenone-3) | Authorized up to 6% | Authorized up to 6% |
| Zinc Oxide (INCI: Zinc Oxide) | Authorized up to 25% | Authorized up to 25% |
| Padimate O (INCI: Ethylhexyl Dimethyl PABA) | Authorized up to 8% | Authorized up to 8% |
| Trolamine Salicylate (INCI: Triethanolamine) | Permitted up to 12% | / |
| Sulisobenzone (INCI: Benzophenone-4) | Authorized up to 10% | Authorized up to 5% |
| Tris-Biphenyl Triazine (INCI: Tris-Biphenyl Triazine) | / | Authorized up to 10% |
The regulation of sunscreens in the United States and the European Union.
Sources: U.S. Food and Drug Administration. Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (2021) / Regulation (EC) No 1223/2009 of the European Parliament and of the Council.
Sources
Règlement (CE) n°1223/2009 du Parlement Européen et du Conseil.
U.S. Food and Drug Administration (FDA). Final Administrative Orders for Over-the-Counter Monographs; Availability (2021).
U.S. Food and Drug Administration (FDA). Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (2021).
FIVENSON D. & al. Sunscreens: UV filters to protect us: Part 1: Changing regulations and choices for optimal sun protection. International Journal of Women's Dermatology (2021).
National Academy of Sciences. Introduction to Sunscreens and Their UV Filters. Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health (2022).
LIM H. W. & al. Ultraviolet filters in the United States and European Union: A review of safety and implications for the future of US sunscreens. Journal of the American Academy of Dermatology (2023).
HEPPT M. & al. Ultraviolet Filters: Dissecting Current Facts and Myths. Journal of Clinical Medicine (2024).
American Academy of Dermatology. Skin Cancer (2025).
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