WASHINGTON – A milestone was reached today that could finally bring U.S. consumers access to the type of modern, more effective sun protection used abroad for decades: The Food and Drug Administration is proposing classifying bemotrizinol as an active ingredient in over-the-counter sunscreens.
The move is part of the agency’s renewed effort to modernize the outdated sunscreen marketplace and encourage innovation.
According to the FDA review, bemotrizinol provides strong broad-spectrum protection, safeguarding consumers against both ultraviolet A and B, or UVA and UVB, rays. UVA radiation can penetrate the skin more deeply than UVB rays and is associated with skin aging and cancer, including melanoma.
The ingredient also shows very low absorption through the skin and rarely causes irritation, the agency says.
If the FDA finalizes its plan, bemotrizinol would become the first new active sunscreen ingredient allowed on the U.S. market in decades. The new ingredient gives adults and children 6 months and older access to a much-needed non-mineral option with stronger UVA protection.
The FDA will publish its review of the ingredient in the Federal Register on December 12 and take public comment on it for 45 days.
Call for safer sunscreens
For more than 20 years, the Environmental Working Group has pushed the FDA and the industry to bring safer, more effective sunscreen ingredients to U.S. consumers.
EWG has documented the shortcomings of many sunscreens sold in the U.S. The organization has also long urged the adoption of modern ingredients used widely in Europe and elsewhere that offer better, more reliable protection against the risks of sun exposure.
“This proposal signals real hope for public health,” said David Andrews, Ph.D., EWG’s acting chief science officer. “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. Approving bemotrizinol would finally begin to close the gap between U.S. consumers and the rest of the world,” he added.
EWG first urged the FDA in 2019 to add bemotrizinol and several other modern filters to the list of approved U.S. sunscreen ingredients. The request cited promising safety data and superior UVA performance.
Bemotrizinol is already widely used in sunscreens around the world, but it has never been approved for use in the U.S. Today’s proposed order responds to a request from its manufacturer, DSM Nutritional Products, to allow concentrations 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.
“The FDA’s proposal is a major step toward aligning U.S. sunscreen availability with public health science. Today’s announcement also shows that it’s possible to conduct the necessary studies to show that filters are both safe and effective,” she added.
Guide to Sunscreens
In 2021, EWG scientists tested 51 sunscreens with a sun protection factor, or SPF, between 15 and 110. The scientists found that many of the products offered just a quarter of their stated SPF protection against UVA rays.
Since 2007, EWG has published its annual Guide to Sunscreens to help consumers navigate misleading marketing claims, outdated regulations and inconsistent UVA protection.
Most top-scoring sunscreen products in the guide, and those EWG recommends, are mineral sunscreens formulated with zinc oxide or titanium dioxide. These mineral-based sunscreens remain top choices.
And now bemotrizinol improves the variety of options available for use in non-mineral sunscreen products.
EWG will continue to advocate for strong safety standards, better UVA performance and the removal of ineffective or potentially harmful sunscreen chemicals.
The Environmental Working Group (EWG) is a nonprofit, non-partisan organization that empowers people to live healthier lives in a healthier environment. Through research, advocacy and unique education tools, EWG drives consumer choice and civic action.
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