Sunscreen Filters: What Does the Regulation Say 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.

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.

These regulatory differences explain why Typology’s sun care products are not available in the United States.

Our SPF products are formulated with sunscreen filters that we have selected for their excellent safety profile, both for human health and for the environment, and that ensure a non-whitening finish. These filters are widely used and approved in Europe but are not included in the limited list of filters authorized by the FDA in the United States. This difference prevents us from completing the required OTC procedure to market them in the US. We are closely monitoring changes in these regulations in the hope of offering our sun care products to American customers in the future.

Currently, 28 sunscreen filters are authorized in the European Union, compared to only 16 in the United States.

• 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).