The sun does not recognise borders, unlike regulations. While the European Union permits 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 decipher this topic together.
Sunscreen filters: what does the regulation say in the United States?
Summary
Published on May 14, 2025, by Pauline, Chemical Engineer — 10 min of reading
Themes:
How are sunscreens regulated in the United States?
More than a cosmetic procedure, sun protection is a major public health issue. With over 3 million cases of skin cancer 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 sun creams 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 regulations, specifically Regulation (EC) No 1223/2009 of the European Parliament and Council, the United States categorises sunscreens as "over-the-counter (OTC)" drugs, which are medications available for purchase 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 authority that, among other things, has the power to authorise or prohibit the marketing of drugs on American territory, is thus a lengthy and costly process, hardly compatible with the pace of cosmetic innovation.
This regulatory framework also defines which ingredients are recognised as "Generally Recognized As Safe and Effective", or GRASE, that is, 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 at modernisation was made in 2021, when the FDA published an order relating to over-the-counter drug monographs. The aim was to establish the official list of UV filters recognised as GRASE. Of the 16 filters still authorised in the United States to date, 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 recognised as GRASE | UV filters not recognised as GRASE due to safety concerns | UV filters not recognised 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 |
FDA's GRASE Categorisation of UV Filters 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 within a regulatory grey area : their status is provisional, pending additional toxicological data, particularly on systemic absorption. This caution is the reason for the inertia of the American market in terms of 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 seemingly having access to a wide range of sun protection, they are in fact limited in their choices. The near absence of innovative UV filters in formulas makes it difficult to formulate sun creams that effectively cover the entire UV spectrum, including UVA, the primary cause of photoaging. The sensory experience of sun products also suffers from regulatory requirements and 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 therefore a real need for new UV filters in the United States today.
What are the UV filters authorised in the United States and the European Union?
Currently, 28 sunscreens are authorised 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) | Authorised up to 15% | Permitted up to 5% |
| Amiloxate (INCI: Isoamyl p-Methoxycinnamate) | / | Authorised up to 10% |
| Anisotriazine (INCI: Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine) | / | Authorised up to 10% |
| Avobenzone (INCI: Butyl Methoxydibenzoylmethane) | Permitted up to 3% | Permitted up to 5% |
| Diethylamino Hydroxybenzoyl Hexyl Benzoate (INCI: Diethylamino Hydroxybenzoyl Hexyl Benzoate) | / | Authorised up to 10% |
| Bisoctrizole (INCI: Methylene Bis-Benzotriazolyl Tetramethylbutylphenol) | / | Authorised up to 10% |
| Bisimidazylate (INCI: Disodium Phenyl Dibenzimidazole Tetrasulfonate) | / | Authorised up to 10% |
| Cinoxate (INCI: Cinoxate) | Permitted up to 3% | / |
| Diethylhexyl Butamido Triazone (INCI: Diethylhexyl Butamido Triazone) | / | Authorised up to 10% |
| Dimethicodiethylbenzalmalonate (INCI: Polysilicone-15) | / | Authorised up to 10% |
| Dioxybenzone (INCI: Benzophenone-8) | Permitted up to 3% | / |
| Titanium Dioxide (INCI: Titanium Dioxide) | Permitted up to 25% | Permitted up to 25% |
| Ecamsule (INCI: Terephthalylidene Dicamphor Sulphonic Acid) | / | Authorised up to 10% |
| Ensulizole (INCI: Phenylbenzimidazole Sulfonic Acid) | Permitted up to 4% | Permitted up to 8% |
| Enzacamene (INCI: 4-Methylbenzylidene Camphor) | / | Permitted up to 4% |
| Ethyl-4-aminobenzoate ethoxylate (INCI: PEG-25 PABA) | / | Authorised up to 10% |
| Homosalate (INCI: Homosalate) | Authorised up to 15% | Permitted up to 7.34% |
| Meradimate (INCI: Meradimate) | Permitted up to 5% | / |
| Camphor Benzalkonium Methosulfate (INCI: Camphor Benzalkonium Methosulfate) | / | Permitted up to 5% |
| Mexoryl SL (INCI: Benzylidene Camphor Sulfonic Acid) | / | Permitted up to 6% |
| Mexoryl SW (INCI: Polyacrylamidomethyl Benzylidene Camphor) | / | Permitted up to 6% |
| Mexoryl XL (INCI: Drometrizole Trisiloxane) | / | Authorised up to 15% |
| Octinoxate (INCI: Ethylhexyl Methoxycinnamate) | Permitted up to 7.5% | Authorised up to 10% |
| Octisalate (INCI: Ethylhexyl Salicylate) | Permitted up to 5% | Permitted up to 5% |
| Octocrylene (INCI: Octocrylene) | Authorised up to 10% | Authorised up to 10% |
| Octyl triazone (INCI: Ethylhexyl Triazone) | / | Permitted up to 5% |
| Oxybenzone (INCI: Benzophenone-3) | Permitted up to 6% | Permitted up to 6% |
| Zinc Oxide (INCI: Zinc Oxide) | Permitted up to 25% | Permitted up to 25% |
| Padimate O (INCI: Ethylhexyl Dimethyl PABA) | Permitted up to 8% | Permitted up to 8% |
| Trolamine Salicylate (INCI: Triethanolamine) | Permitted up to 12% | / |
| Sulisobenzone (INCI: Benzophenone-4) | Authorised up to 10% | Permitted up to 5% |
| Tris-biphenyl triazine (INCI: Tris-Biphenyl Triazine) | / | Authorised 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 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).
