BATCH-5909 · filed
Bemotrizinol gets FDA nod, ending 27-year sunscreen filter drought
BASF's Tinosorb S (Bemotrizinol) cleared FDA on June 15, 2026 as the first new sunscreen active in 27 years. The triazine filter delivers absorption peaks at 310 nm and 340 nm, stabilizes avobenzone, and pushes critical wavelength past 370 nm.
By Amara Osei · · 3 min read · 586 words
Composition
- Bemotrizinol (INCI: Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine) approved by FDA on June 15, 2026 as the first new sunscreen active in 27 years.
- Tinosorb S shows absorption maxima at approximately 310 nm and 340 nm, covering UVB through UVA ranges.
- Combined with avobenzone or Z-COTE zinc oxides, the filter pushes critical wavelength above 370 nm, the FDA broad-spectrum threshold.
- BASF holds U.S. marketing rights through a license agreement with DSM Nutritional Products LLC, with the ingredient originally developed by Ciba Specialty Chemicals.
- Quoted spokesperson: Brandon Crist, Vice President of Business Management at BASF Personal Care Americas.
Bemotrizinol became the first new sunscreen active ingredient approved by the U.S. Food and Drug Administration in 27 years on June 15, 2026, clearing BASF Personal Care to market Tinosorb S in the United States. The green light ends a drought that left American formulators working from a UV-filter palette last refreshed in 1999.
The approval covers chemical name Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (INCI: Bemotrizinol, abbreviated BEMT). BASF holds the U.S. marketing license through a deal with DSM Nutritional Products LLC.
What does the ruling change for U.S. formulators?
For the first time since the late 1990s, R&D teams gain a triazine-class filter engineered for high-performance, broad-spectrum protection. Until now, U.S. sunscreen chemists leaned on avobenzone, octinoxate and a handful of older organics, all constrained by photostability limits or shallow UVA depth.
Tinosorb S carries absorption maxima at approximately 310 nm and 340 nm, covering the UVB-to-UVA range that drives erythema and photoaging. It also functions as a photostabilizer for more labile organics.
Key performance features cited for the ingredient:
- Stabilizes avobenzone against photodegradation, extending UVA-protection durability in complex formulas.
- When combined with avobenzone or Z-COTE zinc oxides, pushes critical wavelength above 370 nm, the threshold for the FDA's broad-spectrum claim.
- Large molecular structure limits percutaneous absorption, a profile suited to sensitive-skin and baby-care lines.
How does BASF position the launch?
"Tinosorb S represents decades of BASF innovation in photoprotection," said Brandon Crist, Vice President of Business Management at BASF Personal Care Americas. "Following this FDA approval, we are proud to introduce this advanced UV filter to the U.S. market, providing formulators a new opportunity to deliver the high-performance, broad-spectrum sun protection that today's consumers demand."
The compound was originally developed by Ciba Specialty Chemicals and moved into BASF's portfolio through acquisition. It has clearance in the European Union, Australia and several Asian markets, giving the company a globally harmonized dossier to leverage domestically.
What regulatory precedent does the decision set?
Industry observers and trade associations had pressed FDA for years to clear additional UV filters using the Time and Extent Application (TEA) pathway. Bemotrizinol's approval effectively validates that route for the first time since the pathway was created, opening the door for other pending candidates awaiting GRASE review.
The 27-year gap stems from the agency's GRASE re-evaluation process, which required fresh safety data on older actives alongside new submissions. Previous interim approvals, including ecamsule and the 2019 mineral and TEA filings, did not deliver a triazine-class filter of this breadth.
What can brands now build with it?
Brand owners can assemble a broader, more globally aligned UVA-and-UVB toolbox. The practical implications include:
- Sun-care SKUs sold in Paris or Seoul can mirror U.S. formulas more closely, cutting duplication in clinical testing and stability work.
- Sensitive-skin and dermatology-leaning brands gain a high-efficiency filter with documented low skin penetration.
- Premium anti-aging lines tied to blue-light or HEVL defense can cite the 340 nm peak for supporting claims, subject to substantiation.
What's the next data point to watch?
The next signal will be FDA's treatment of other pending sunscreen TEA applications, including additional triazine and phenylbenzimidazole candidates. Trade readers should track Federal Register notices for further GRASE determinations through 2026, and watch for BASF's first commercial SKU listings and INCI declarations on U.S. Drug Facts panels later this year.
via hpcimedia.com (Original)
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End of monograph · 3 min read