FDA Bemotrizinol Decision Now Expected This Summer

Federal regulators are now within weeks of issuing a final order on bemotrizinol, the broad-spectrum UV filter that would become the first new U.S. sunscreen active ingredient approved since 1999. The FDA confirmed in its December 11, 2025 proposed administrative order that the agency expects to finalize the decision in summer or fall 2026, with sunscreens containing the ingredient potentially appearing on U.S. shelves by late 2026. **Key Takeaways** - The FDA expects to issue a final order on bemotrizinol in summer or fall 2026, with sunscreens containing the ingredient potentially reaching U.S. shelves by late 2026, according to FDA statements following the December 11, 2025 proposed administrative order. - Dr. Joanna Walker, director of the Rare and Advanced Skin Cancer Clinic at Penn Medicine, told WHYY on May 26, 2026 that the approval would be "a really big win" because the last new U.S. sunscreen filter was approved in 1999. - Bemotrizinol is proposed at concentrations up to 6 percent in OTC sunscreens for use in adults and children 6 months and older, per the Federal Register notice published December 12, 2025. - Photostability testing has shown bemotrizinol remains approximately 98.4 percent intact after 50 minimal erythemal doses of UV exposure, a level that has supported its use in Europe, Asia, and Australia for over two decades. The proposed order would amend Over-the-Counter Monograph M020 to add bemotrizinol at concentrations up to 6 percent. Public comment closed on January 26, 2026, and the agency is now reviewing the safety and efficacy submission package from BASF, which holds the original development data on the molecule. Dr. Joanna Walker, director of the Rare and Advanced Skin Cancer Clinic at Penn Medicine, told WHYY on May 26, 2026 that the timing represents "a really big win, because we've only had kind of limited ingredients to work with" since 1999. ## A Twenty-Five-Year Gap in U.S. Sunscreen Chemistry The U.S. sunscreen active ingredient list has remained effectively frozen since the Clinton administration. Avobenzone, the workhorse UVA filter in most American chemical sunscreens, received its final monograph clearance in 1999. Since then, the European market has gained access to a generation of newer organic UV filters with broader spectrum coverage and stronger photostability, including bemotrizinol (sold under the trade name Tinosorb S), bisoctrizole, and tris-biphenyl triazine. Australia and Asia followed. Health Canada approved bemotrizinol in 2023. The reason for the U.S. delay sits in the regulatory architecture rather than the science. Sunscreens in the United States are regulated as over-the-counter drugs, not cosmetics, which means adding a new active ingredient requires the kind of safety and efficacy review usually reserved for pharmaceuticals. The 2020 CARES Act overhauled the OTC monograph process and reopened the path for new filters, which is what allowed the bemotrizinol application to advance. ## How Does Bemotrizinol Differ From Current U.S. Sunscreen Filters? Bemotrizinol is a triazine-class organic filter with dual absorption peaks at approximately 310 nanometers in the UVB range and 343 to 345 nanometers in the UVA range, providing continuous absorption from 280 to 400 nanometers. Photostability data submitted to regulators shows the molecule retains approximately 98.4 percent of its filtering activity after 50 minimal erythemal doses of UV exposure, a property attributed to two intramolecular hydrogen bonds that allow it to dissipate absorbed energy without breaking down. Avobenzone, by contrast, degrades meaningfully under UV exposure unless paired with stabilizers, which is why current U.S. formulations often combine it with octocrylene or other co-actives. The FDA's safety review noted that bemotrizinol shows very low systemic absorption through the skin and rarely causes irritation, a contrast with several existing U.S. UV filters that have come under scrutiny for hormonal activity and reef toxicity. SkinCareful covered the underlying photochemistry of bemotrizinol in greater depth in an earlier piece on [the first new U.S. UV filter in 25 years](https://skincareful.care/science/bemotrizinol-sunscreen-fda-uva-filter/). ## What Should Readers Expect Before Year-End? Even with a final order this summer, bemotrizinol-containing sunscreens will not reach U.S. shelves immediately. Cosmetic manufacturers need lead time to reformulate, test for stability in their specific bases, and complete production cycles. Industry analysts have suggested a realistic first-wave appearance in late 2026 or early 2027 for major U.S. brands, with smaller and direct-to-consumer brands likely to move faster. European brands that already formulate with bemotrizinol abroad, including La Roche-Posay, Bioderma, and Avène, are positioned to introduce U.S.-compliant SKUs once the monograph is amended. Until then, the AAD's standing recommendation continues to apply: broad-spectrum sunscreen with SPF 30 or higher, applied in a thick film and reapplied every one to two hours, with water-resistance ratings of 40 or 80 minutes depending on activity. Pittsburgh dermatologist Dr. Walker, in her May 26 commentary to WHYY, reinforced the daily-use point. "There's also data to say that people who use it regularly every morning have a lower risk and lower number of skin cancers compared to the occasional, 'Oh, I feel like I might need it today' users," she said. Coverage of the broader U.S. sunscreen landscape, including the EWG's recent finding that only 20 percent of products passed its 2026 safety audit, is available in SkinCareful's review of [the 2026 EWG sunscreen guide](https://skincareful.care/science/ewg-2026-sunscreen-guide-safety-audit/). Sources cited in this article include the [FDA proposed order on bemotrizinol](https://www.fda.gov/news-events/press-announcements/fda-proposes-expanding-sunscreen-active-ingredient-list), the [Federal Register notice amending OTC Monograph M020](https://www.federalregister.gov/documents/2025/12/12/2025-22649/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use), and the [WHYY/WESA report featuring Penn Medicine dermatology commentary](https://www.wesa.fm/health-science-tech/2026-05-26/sunscreen-ingredient-bemotrizinol).