The FDA is proposing to approve bemotrizinol, a sunscreen ingredient already used worldwide for years but never allowed in the U.S., marking the first new active sunscreen ingredient approval in decades. The ingredient provides broad-spectrum protection against both UVA and UVB rays with very low skin absorption and minimal irritation, according to the FDA's review .

Why Has the U.S. Sunscreen Market Been So Outdated?

For more than 20 years, consumer advocates and scientists have pushed the FDA to modernize America's sunscreen options. The Environmental Working Group (EWG), a nonprofit organization focused on environmental health, has documented significant gaps between what Americans can buy and what's available in Europe and other parts of the world. In 2021, EWG scientists tested 51 sunscreens with SPF (sun protection factor) ratings between 15 and 110 and found that many products delivered only about one-quarter of their stated SPF protection against UVA rays . This discrepancy matters because UVA radiation penetrates skin more deeply than UVB rays and is linked to skin aging and melanoma.

The problem stems from outdated FDA regulations that have limited the approved active ingredients available to sunscreen manufacturers in the U.S. While mineral sunscreens formulated with zinc oxide or titanium dioxide remain effective options, consumers who prefer non-mineral products have had very limited choices. EWG first urged the FDA in 2019 to add bemotrizinol and several other modern filters to the approved ingredient list, citing promising safety data and superior UVA performance .

What Makes Bemotrizinol Different From Current Sunscreen Options?

Bemotrizinol offers several advantages that distinguish it from the chemical sunscreen ingredients currently approved in the U.S. According to the FDA's review, the ingredient provides strong broad-spectrum protection against both UVA and UVB rays while showing very low absorption through the skin and rarely causing irritation . The manufacturer, DSM Nutritional Products, has requested approval for concentrations up to 6% in sunscreen formulations.

The ingredient has been widely used in sunscreens around the world for years, giving manufacturers and regulators in other countries substantial real-world safety data. This global track record was part of what prompted the FDA to reconsider its sunscreen ingredient approval process. The proposal represents what the FDA describes as part of its renewed effort to modernize the outdated sunscreen marketplace and encourage innovation in sun protection products.

How to Navigate Sunscreen Choices While Waiting for FDA Approval

• Mineral Sunscreens: Products formulated with zinc oxide or titanium dioxide remain top-scoring options in EWG's annual Guide to Sunscreens and continue to be recommended by the organization as reliable choices for broad-spectrum protection .
• Check UVA Performance: Don't rely solely on SPF numbers. Look for products that offer strong UVA protection, as many sunscreens marketed with high SPF ratings may deliver significantly less UVA protection than advertised .
• Read Labels Carefully: Be aware of marketing claims that may not reflect actual protection levels. EWG has published its annual Guide to Sunscreens since 2007 specifically to help consumers navigate misleading marketing and inconsistent UVA protection across products .

The FDA will publish its review of bemotrizinol in the Federal Register on December 12 and will accept public comment for 45 days before making a final decision .

What Do Experts Say About This Approval Proposal?

"This proposal signals real hope for public health. 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," said David Andrews, Ph.D., acting chief science officer at the Environmental Working Group.

David Andrews, Ph.D., Acting Chief Science Officer at the Environmental Working Group

Melanie Benesh, EWG's vice president of government affairs, emphasized the broader significance of this regulatory shift. "Modernizing our sunscreen market is long overdue," she stated. "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" .

Melanie Benesh, EWG's vice president of government affairs

The approval of bemotrizinol would expand the non-mineral sunscreen options available to adults and children 6 months and older, giving families more choices for sun protection. EWG has committed to continuing its advocacy for strong safety standards, better UVA performance, and the removal of ineffective or potentially harmful sunscreen chemicals from the market .