AINEWS
FDA clears first new sunscreen chemical in 25 years
Bemotrizinol, a UVA filtering active long available in Europe, Australia and parts of Asia, is now permitted in US over the counter sunscreens after a two decade approval drought.
Bemotrizinol, a UVA filtering active long available in Europe, Australia and parts of Asia, is now permitted in US over the counter sunscreens after a two decade approval drought.
The US sunscreen market just got its first new active ingredient in a quarter century. The FDA has approved bemotrizinol, a chemical that filters UVA rays, the longer-wavelength ultraviolet light that drives skin aging and a meaningful share of skin-cancer risk. The approval ends a 25-year freeze on new over-the-counter UV filters and signals that a long-stalled regulatory pipeline may finally be moving.
Bemotrizinol has been on shelves in Europe, Australia, and parts of Asia for at least a decade. American sunscreens have relied on the same short list of active ingredients approved before 2000, while European formulas have rotated through newer UVA filters with stronger photostability and longer-lasting protection. The 25-year gap is not a mystery of chemistry. It is a backlog.
The approval does not mean a new bottle of sunscreen will appear on US shelves next week. Manufacturers can now incorporate bemotrizinol into over-the-counter formulations, but the first products using it will need separate review, formulation work, and likely a year or more before they reach consumers. Existing sunscreens remain on the market and unchanged. The FDA's action is not a recall, not a reformulation order, and not a signal that prior products are unsafe. It is a permission slip that has been a long time coming.
Two things are worth watching next. The FDA's queue contains additional UV filters, including several that have been waiting for safety reviews for years. The agency's willingness to clear bemotrizinol suggests movement on that backlog, though the FDA has not committed to a timeline. UVA protection has also historically been the under-served half of US sunscreen design. American labels have long emphasized sunburn protection, measured by SPF, which is driven mostly by UVB coverage. UVA protection, which the FDA has not required to be labeled as clearly, is where newer European filters have made the biggest gains. The arrival of bemotrizinol gives formulators another tool for that half of the spectrum.
US consumers have had a narrower chemistry set for years, and the rest of the world has had access to better UVA filters all along. The FDA's decision is real progress on a real backlog. It also arrives about two decades after it could have.