The Food and Drug Administration on Tuesday added bemotrizinol to the list of permitted active ingredients in over-the-counter sunscreens, the first addition to that list since the 1990s. The ingredient, also known as BEMT, blocks both ultraviolet A and ultraviolet B light rays and has been used in sunscreens in the European Union since 2000, with Canada, Australia, and several Asian countries following soon after, according to the American Chemical Society.
Health and Human Services Secretary Robert F. Kennedy Jr. said the agency is “advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years.” He said bemotrizinol has been used safely in Europe for decades and that the FDA’s action “will increase competition and consumer confidence in sunscreen products.”
The FDA said the ingredient has low levels of absorption through the skin and into the body and is generally recognized as safe and effective for adults and children 6 months old and older.
The American Cancer Society said UVB rays have more energy, cause visible sunburns, and are the type blocked by most U.S. sunscreens currently on the market. However, UVA rays can also cause skin cancers, the group said. They also cause skin cells to age and can cause indirect damage to cells’ DNA. According to the ACS, about 95% of the UV rays that reach the ground are UVA rays, making broad-spectrum protection particularly important.
The FDA said an over-the-counter monograph drug — such as a sunscreen — can enter the market without an approved drug application if it meets requirements under the OTC monograph system. DSM Nutritional Products LLC submitted an OTC monograph order request to add bemotrizinol, at concentrations up to 6%, as a new active ingredient in the OTC monograph for sunscreens. The FDA proposed the addition in December 2025, and the public could submit comments through Jan. 26.
The addition of bemotrizinol brings the U.S. market in line with many other countries where the ingredient has been available for more than two decades. The FDA’s decision follows a broader trend of the agency reviewing sunscreen ingredients to expand consumer options while evaluating safety data.