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.
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.