A decision awaited for years, an ingredient already widespread abroad and now authorized in the United States as well. The Food and Drug Administration (FDA) has included bemotrizinol among the active ingredients allowed in sunscreens. The green light marks the first update of the over-the-counter UV filter list since the 1990s and opens the way for the marketing of new formulations in the coming months, after a long regulatory and industrial process.
A NEW ENTRY IN THE FDA LIST
The FDA has officially expanded the list of active ingredients allowed in sunscreen products by including the chemical compound bemotrizinol, already used for some time in Europe, Asia, and Australia. The agency described the action as part of an update to the regulatory system for over-the-counter drugs, highlighting that this is the first new UV filter introduced in over two decades.
THE REGULATORY PROCESS AND DECISION-MAKING PATH
The authorization comes at the end of a procedure initiated at the request of the Dutch company DSM-Firmenich, which submitted an application to include bemotrizinol up to a concentration of 6% in the monograph of over-the-counter sunscreen products. The FDA published a proposal in December 2025, followed by a public consultation phase, and then issued the final order.
According to the agency, the measure falls within the simplified process provided by the CARES Act, which allows modification of OTC monographs through administrative orders without a new full drug approval request.
FEATURES OF THE NEW UV FILTER
Bemotrizinol is a broad-spectrum ultraviolet filter, capable of protecting against both UVA and UVB rays. U.S. health authorities describe it as a substance characterized by low skin absorbability and a safety profile already documented by years of international use.
According to what is reported by experts cited in the U.S. media, its stability under sunlight distinguishes it from some chemical filters already available on the American market, which tend to degrade more quickly during exposure.
AN ALREADY ESTABLISHED USE
The compound has been used for years in numerous countries outside the United States, where it has been integrated into sunscreen formulations marketed in Europe and Asia. This widespread use has made bemotrizinol one of the most anticipated ingredients among those not yet authorized in the U.S. market.
Its approval in the United States follows a long and costly regulatory path, which required significant investments by the industry to obtain FDA recognition.
INDUSTRY REACTIONS AND MARKET PROSPECTS
Health authorities and some dermatological sector organizations, reports Axios, have described the measure as a significant update in the landscape of available sunscreen filters. The American Academy of Dermatology called it an “important step for public health,” highlighting how many countries have a greater number of approved ingredients compared to the United States.
According to the manufacturer DSM-Firmenich, the first products containing bemotrizinol should reach the U.S. market in the months following approval, with an initial 18-month commercial exclusivity window for marketing the active ingredient.
NOT TOTAL BUT FUNDAMENTAL EFFECTIVENESS
Experts remind that sunscreens do not guarantee total protection from UV rays. As explains Giovanni Leone, director of Photodermatology at San Gallicano in Rome, “no cream can protect us 100 percent from ultraviolet radiation,” which is why protection must always be integrated with other measures such as clothing and reducing sun exposure.
BROAD-SPECTRUM PROTECTION IS NECESSARY
The scientific community also agrees that effective protection must cover both UVA and UVB rays. The former are associated with skin aging and deep skin damage, the latter with sunburns. For this reason, “sunscreen products must have broad-spectrum protection, against UVA and UVB,” continues Leone, with a minimum balance between the two protections also required by European regulations.
ARE SUNSCREENS REALLY EFFECTIVE?
Real effectiveness decisively depends on application. According to AIRC, “if applied in the right amount and regularly, sunscreens become effective barriers” in reducing sunburn, aging, and skin cancer risk. However, protection is never absolute and requires frequent reapplications.
Some chemical filters can degrade in sunlight, reducing protection duration. For this reason, photostability and the need for reapplication every few hours are considered key elements to maintain effectiveness during exposure.
THE BENEFITS OF PREVENTION
Experts finally report that regular use of sunscreens is associated with a reduced risk of skin damage. A study cited in JAMA highlighted a 27% decrease in melanoma cases among at-risk individuals who regularly used sun protection.
