FDA Approval of PARSOL® Shield (bemotrizinol, BEMT)
On 1 September 2026, dsm-firmenich announced that the U.S. Food and Drug Administration has approved its sunscreen active PARSOL® Shield (bemotrizinol, BEMT) for the United States market. The approval is described as the first new sunscreen active to receive FDA clearance in more than 25 years, evaluated under the modernised GRASE (Generally Recognized as Safe and Effective) and MUsT (Maximal Usage Trial) guidelines.
The company highlighted that the clearance represents a major milestone for sunscreen innovation and public skin health in the United States, expanding access to next‑generation UV protection and creating new formulation opportunities for the industry. Parand Salmassinia, Beauty & Care President at dsm-firmenich, said the approval reflects years of scientific leadership, regulatory collaboration and a commitment to bring meaningful innovation to consumers.
Clinical studies involving approximately 500 participants that reflect the demographic diversity of the U.S. population demonstrated exceptional UV efficacy, excellent tolerability and a strong safety profile for PARSOL® Shield. The active is positioned to help reduce the risk of skin cancer, protect against long‑term UV‑induced skin damage and prevent premature photo‑aging.
For formulators, the ingredient enables silky, lightweight sunscreen textures with strong photostability and formulation flexibility. Dr. Jochen Klock, Director Global Regulatory Affairs, Beauty & Care, noted that the approval closes a longstanding innovation gap in the U.S. sunscreen market and reflects a modern scientific and regulatory standard that can expand access to advanced UV protection for American consumers.
PARSOL® Shield has already received approval in multiple global regions, allowing the development of worldwide sunscreen formulations that simplify product strategy, reduce formulation complexity and accelerate speed‑to‑market. Its broad‑spectrum protection, high efficiency at low concentrations and strong eco‑profile support brands in meeting evolving sustainability expectations and reporting requirements.
Ashley Lebbe, Vice President Global Sales, Beauty & Care, said customers have been waiting for greater flexibility and innovation in the U.S. sunscreen market, and that the approval opens new opportunities to create future‑ready sunscreen solutions with global scalability and an elevated consumer experience.
The approval also reinforces dsm‑firmenich’s ongoing commitment to public skin‑health advocacy, including collaborations with regulators, NGOs, legislators and organisations such as the Skin Cancer Foundation and the Destination Healthy Skin initiative.
dsm‑firmenich is a Swiss‑Dutch company headquartered in Kaiseraugst, Switzerland and Maastricht, Netherlands, listed on Euronext Amsterdam, operating in nearly 60 countries, generating revenues of more than €12 billion and employing approximately 30 000 people.