If you’re familiar with the sunscreen world—and you should be, considering we should all be wearing SPF every single day—you know that America is way behind in sunscreen innovation. This is in part because in the U.S., sunscreen is regulated as a drug rather than a cosmetic, which means it has to undergo robust testing via the Food & Drug Administration before hitting shelves. However, the FDA has finally taken a step toward approving a new active sunscreen ingredient (also called a filter), which would be the first major sunscreen-related approval since 1999—yes, 1999!
On December 11, the administration announced a formal proposal to add bemotrizinol to the list of approved active ingredients for over-the-counter sunscreens. According to the FDA, bemotrizinol (or BEMT) “provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation.” Should BEMT approvals be finalized, it will be considered safe and effective by the FDA and recommended for use for adults and children ages six months and older.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”
The FDA has historically declined to comment on its approval timelines, and it’ll likely be a long while until products formulated with BEMT are approved and made available. In the meantime, interested parties can review the full amendment proposal. Starting December 12, anyone interested can participate in the public comment process, which allows Americans to share direct feedback to the FDA for or against a proposal. If you’ve got strong feelings about sunscreen, it may be time to hop in the FDA’s comments.
Cosmetic chemist Kelly Dobos previously wrote in Allure that chemists in the U.S. have a “pretty limited toolbox” for sunscreen formulation: just 16 active sunscreen ingredients, only eight of which are commonly used. For contrast, in Japan, formulators can choose from over 30 approved filters. According to Dobos, who attended the 2025 Sunscreen Symposium, BEMT is manufactured by DSM-Firmenich, which has been trying to get the ingredient approved in the U.S. for 20 years; it cost them roughly $20 million to bring it to market.
