FDA Approves Bemotrizinol, First New Sunscreen Ingredient in Decades
Long used in Europe and Asia, it will soon be used in U.S. sunscreens
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U.S. consumers will soon have more options for sunscreens. This week, the Food and Drug Administration approved a new active ingredient called bemotrizinol, which works by filtering out ultraviolet radiation from the sun. It’s the first UV filter that the agency has okayed in more than 25 years.
Bemotrizinol has long been used in sunscreens in Europe and other parts of the world, where sunscreens are regulated as cosmetics. (It was first approved in Europe in 1999.) In the U.S., the FDA considers sunscreen a drug, and there are far fewer approved UV filters than in other countries.
This news is very positive, says Mona Gohara, MD, a clinical professor in the department of dermatology at Yale School of Medicine in New Haven, Conn. “Bemotrizinol is a highly effective, broad-spectrum UV filter that has been used safely in Europe, Asia, and many other countries for over two decades,” she says. “More sunscreen options generally means better sunscreen use, and better sunscreen use saves lives.”
Here’s what to know about bemotrizinol.
What Is Bemotrizinol and How Effective Is It?
Bemotrizinol is a chemical sunscreen active ingredient that protects against both UVA and UVB rays. UVB rays cause sunburn. UVA rays primarily cause skin aging, and both types contribute to skin cancer risk.
Is Bemotrizinol Safe?
As part of its decision to add bemotrizinol as a sunscreen ingredient, the FDA reviewed a range of studies examining bemotrizinol’s safety—just as it does for any new drug intended to be sold over the counter. The agency determined that there was adequate evidence to support bemotrizinol as safe for use in sunscreens for both adults and children at least 6 months old.
One important feature of bemotrizinol is that, because of its large molecule size, it is absorbed into the bloodstream through the skin at lower rates than other chemical sunscreen active ingredients.
In 2019 and 2020, the FDA released research showing that six common chemical sunscreen ingredients—avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate—entered the bloodstream at higher levels than previously believed. The actual health implications of that weren’t, and still aren’t, clear. (And the FDA and health experts do not recommend avoiding sunscreens that contain them.) But the finding highlighted the need for stronger evidence regarding the safety of existing sunscreen ingredients, which the FDA has called for.
It also doesn’t appear to raise the risk of skin irritation or phototoxicity (when an ingredient causes skin to become unusually sensitive to sunlight).
Gohara says that its long history of successful use in Europe and Asia should give consumers added confidence in its safety.
When Will I Be Able to Get Bemotrizinol Sunscreens?
You won’t find sunscreen with bemotrizinol on store shelves just yet. But manufacturers can theoretically start including it in their products as early as Aug. 9, according to an American Academy of Dermatology news release.
As part of this week’s decision, the FDA has granted exclusive marketing rights to one maker of bemotrizinol, DSM-Firmenich, for 18 months. It will sell bemotrizinol to sunscreen makers under the brand name Parasol Shield.
In the meantime, keep up with smart sun safety habits, including staying in the shade whenever possible and using an effective broad-spectrum sunscreen of at least 30 SPF whenever you’re out in the sun. “Bemotrizinol is an exciting addition to our sunscreen toolbox, but it does not make current sunscreens obsolete,” Gohara says.
Consider these top performers from CR tests. Though sunscreens containing bemotrizinol are not yet available, these products use long-approved ingredients and offered great protection in our most recent tests.
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