dsm-firmenich: FDA approves bemotrizinol (PARSOL® Shield) for U.S. suncare
- FDA approval covers bemotrizinol (PARSOL® Shield), the first new sunscreen active approved in the U.S. in more than 25 years under modernized GRASE and MUsT guidelines.
- Clinical studies with nearly 500 U.S. participants showed strong UV efficacy, excellent tolerability and a favorable safety profile.
- PARSOL® Shield delivers broad‑spectrum protection, high photostability, and formulation flexibility enabling silky, lightweight textures at low concentrations.
- Already approved in multiple regions, the ingredient aims to simplify global formulations, reduce complexity and accelerate speed‑to‑market while supporting sustainability goals.
Regulatory milestone
dsm-firmenich announced FDA approval of bemotrizinol, marketed as PARSOL® Shield, marking the first new sunscreen active ingredient authorised in the United States in more than 25 years under modernized GRASE (Generally Recognized as Safe and Effective) and MUsT (Maximal Usage Trial) evaluation guidelines.
Clinical evidence
Clinical studies involving nearly 500 participants representing U.S. population diversity demonstrated strong UV efficacy, excellent tolerability and a favourable safety profile for PARSOL® Shield, supporting its use to reduce skin cancer risk and long‑term UV‑induced damage.
Formulation and market impacts
The ingredient provides broad‑spectrum protection, high photostability and formulation flexibility that enables silky, lightweight textures. Its high efficiency at low concentrations supports an improved eco‑profile, and prior approvals in multiple regions facilitate development of global formulations that can reduce formulation complexity and accelerate speed‑to‑market for customers.
Industry and advocacy context
dsm-firmenich positions the approval as reinforcing its public skin health engagement and ongoing collaborations with regulators, NGOs and organisations including the Skin Cancer Foundation and the Destination Healthy Skin initiative.
Source: dsm-firmenich
