The Food and Drug Administration announced a proposal Thursday to make another sunscreen ingredient available to U.S. manufacturers.
FDA’s Proposal
The agency said a new sunscreen, like bemotrizinol, can be brought to market without an approved drug application if it meets certain requirements. To do so, the FDA must first make a proposal. The proposal must go through a public comment period before it issues the final order and adds bemotrizinol to its list of allowed sunscreen ingredients.
What Is Bemotrizinol?
Bemotrizinol is a UV light filter that has long been available in Europe, Australia and some Asian countries. It is described as a broad‑spectrums chemical sunscreen that is far more stable than many existing filters. “It would not degrade upon exposure to sunlight,” Lim said.
Why Broad‑Spectrum Is Important
UV filters block harmful ultraviolet rays from the sun. To be most effective, they need to be “broad-spectrum,” meaning they block both UVA and UVB rays. “The ‘B’ is ‘burning rays,’ which causes sunburn. The ‘A’ is the ‘aging ray,’ which causes tanning reaction, wrinkle formation,” said Dr. Henry Lim, former chair of dermatology at Henry Ford Health in Detroit and past president of the American Academy of Dermatology. Both, he added, contribute to skin cancer risk.
Chemical vs. Mineral Filters
There are two main types of UV filters used in sunscreens: chemical and mineral. Mineral sunscreens contain zinc oxide or titanium dioxide and can block both UVA and UVB rays, but often leave a white cast on the skin, making chemical filters generally more favorable to consumers. The chemical filter sunscreens available in the U.S. either protect against UVA or UVB. None of the chemical filters in the U.S. are broad‑spectrums on their own. (Sunscreens will often contain a mix of chemical filters to cover both UVA and UVB.) Chemical sunscreens also break down in the sun, so they need to be regularly reapplied.
Safety Profile
Bemotrizinol “does not penetrate the body surface and does not absorb into the bloodstream, so it has a good safety profile,” said Dr. Steven Wang, chief of dermatology at Hoag Memorial Hospital Presbyterian in Newport Beach, California. The FDA has taken a long time to arrive at this point. “The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad,” FDA Commissioner Dr. Marty Makary said in a press release.
Tolerability and Consumer Acceptance
Dr. Adam Friedman, a professor and the chair of dermatology at the GW School of Medicine and Health Sciences in Washington, D.C., added that chemical UV filters “are irritating at baseline, let alone if someone has acne, rosacea, eczema — it’s hard for people to be adherent to them because they sting.” “It does seem to be better tolerated, in comparison to other UV filters,” said Friedman of bemotrizinol. “Bemotrizinol will be a welcome addition to the U.S. sunscreen industry,” Wang said.
Regulatory Pathway
One of the main reasons for the delay is that in the U.S., sunscreen filter ingredients are classified as over‑the‑counter drugs, as opposed to cosmetics, meaning they require clinical trials to test for safety and effectiveness before they can be approved. In Europe, they’re not looked at that way, Friedman said. That’s why they can come out with things much faster.
Timeline
The FDA said that a new sunscreen, like bemotrizinol, can be brought to market without an approved drug application if it meets certain requirements. Ben Nichols, an FDA spokesman, said the agency expects that the final order will come sometime next summer or fall and that sunscreen with bemotrizinol could be sold in the U.S. as early as late 2026.
First New UV Filter in Over 25 Years
Bemotrizinol will also be the first new UV filter in the U.S. in over 25 years. This addition could give U.S. consumers more options and improve the overall effectiveness of sunscreens available in the market.
Key Takeaways
- FDA proposes to add bemotrizinol, a stable, broad‑spectrums chemical sunscreen, to U.S. ingredient list.
- The filter is already used in Europe, Australia and some Asian countries.
- FDA expects final approval by next summer or fall, with sales possible by late 2026.
The announcement marks a significant step toward modernizing U.S. sunscreen regulations and expanding consumer choices for sun protection.
