FDA moves to allow a modern sunscreen ingredient widely used outside the U.S.
Bemotrizinol offers stronger UVA and UVB protection with low skin absorption
Decision could mark first new U.S. sunscreen filter approved in decades
The Food and Drug Administration is proposing to classify bemotrizinol as an active ingredient in over-the-counter sunscreens, a long-awaited step that could finally give U.S. consumers access to more advanced sun protection already used abroad for years.
The proposal is part of the agency’s broader effort to modernize the U.S. sunscreen market, which critics say has lagged far behind Europe and other regions in approving newer, more effective ultraviolet filters.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad,” FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. “We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products. Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”
Strong broad-spectrum protection
According to the FDA’s scientific review, bemotrizinol provides strong broad-spectrum protection against both ultraviolet A and ultraviolet B rays. UVA radiation penetrates the skin more deeply than UVB and is linked to premature aging and skin cancer, including melanoma.
The agency said the ingredient shows very low absorption through the skin and rarely causes irritation — factors that have made it a popular sunscreen filter internationally.
If finalized, the proposal would make bemotrizinol the first new active sunscreen ingredient approved for use in the U.S. in decades. The ingredient would be available for adults and children 6 months and older, offering a non-mineral option with stronger UVA protection.
The FDA plans to publish its proposed order in the Federal Register on December 12 and accept public comment for 45 days.
Long push for modern sunscreen options
Consumer and environmental health advocates welcomed the move as a major shift in U.S. sunscreen policy.
For more than 20 years, the Environmental Working Group has urged the FDA to approve newer sunscreen ingredients already used widely in Europe and other countries. The organization has argued that many sunscreens sold in the U.S. provide inadequate UVA protection and rely on outdated filters.
“This proposal signals real hope for public health,” said David Andrews, Ph.D., acting chief science officer at EWG. “Mineral sunscreens are a top choice for consumers, but for those who prefer non-mineral products the ingredient options have been limited.
“For years, Americans have been denied access to sunscreen ingredients that offer stronger UVA protection with fewer health concerns,” Andrews added. “Approving bemotrizinol would finally begin to close the gap between U.S. consumers and the rest of the world.”
EWG first formally petitioned the FDA in 2019 to add bemotrizinol and several other modern filters to the list of approved U.S. sunscreen ingredients, citing safety data and superior UVA performance.
Industry request and next steps
Bemotrizinol is already used in sunscreens worldwide but has never been approved in the United States. The FDA’s proposed order responds to a request from manufacturer DSM Nutritional Products to allow the ingredient at concentrations of up to 6%.
“Modernizing our sunscreen market is long overdue,” said Melanie Benesh, EWG’s vice president of government affairs. “For too long, American families have had to rely on outdated ingredients while likely safer, more effective options were available overseas.”
Benesh said the proposal also shows that companies can meet FDA standards for demonstrating both safety and effectiveness of new filters.
Why UVA protection matters
EWG research has repeatedly highlighted weaknesses in U.S. sunscreen performance. In a 2021 analysis of 51 sunscreens with SPF ratings between 15 and 110, EWG scientists found many products delivered only about a quarter of their labeled SPF protection against UVA rays.
Since 2007, the group has published its annual Guide to Sunscreens, which evaluates products for safety, UVA protection and marketing claims. Most top-rated sunscreens in the guide are mineral-based, using zinc oxide or titanium dioxide.
Advocates say bemotrizinol could expand choices for consumers who prefer non-mineral sunscreens while improving overall protection against skin cancer and sun-related aging.
EWG said it will continue pushing for stronger UVA standards, improved transparency and the removal of ineffective or potentially harmful sunscreen ingredients as the FDA considers its next steps.