FDA approves first new sunscreen filter in about two decades
The U.S. Food and Drug Administration has approved bemotrizinol as an active ingredient in over-the-counter sunscreens , the first addition to the OTC sunscreen monograph since the late 1990s. The broad-spectrum filter, which guards against both UV-A and UV-B rays, is cleared at concentrations up to 6% after a review found low skin absorption and a low rate of irritation.
The approval is notable less for the chemistry than for the process. Bemotrizinol has been sold in Europe and Asia for years, but new sunscreen filters had been stuck in the US for decades under the old monograph system; this is the first cleared through the streamlined administrative-order pathway created by the 2020 CARES Act, with the agency acting within about seven months of its proposed order. That suggests other long-pending filters could now move faster, narrowing the long-standing gap between US and overseas sunscreen options. Manufacturer DSM Nutritional Products says products using the ingredient could reach US shelves by the end of 2026.