The U.S. Food and Drug Administration has proposed to include dsm-firmenich's Parsol Shield, at a maximum concentration of 6%, as an approved active ingredient in over‑the‑counter (OTC) sunscreens in the United States.
This proposal marks a major milestone as it follows the first-ever Tier 1 OTC Monograph Order Request (OMOR) to be submitted to the FDA—by dsm-firmenich—to amend OTC Monograph M020 and permit Parsol Shield at that 6% concentration.
Watch On-Demand: Parsol Shield – Powering the Next U.S. Sun Care Era
Final Order Anticipated by June 2026
As the sponsor of the Tier 1 OMOR, and with the FDA’s approval, dsm-firmenich’s Parsol Shield will benefit from an 18-month exclusivity in the U.S. market, reinforcing the company's commitment to delivering safe, effective and science-backed solutions for UV protection and skin cancer prevention.
dsm-firmenich anticipates that the FDA will issue a final order by June 2026. When approved, Parsol Shield will be available for use in accordance with the monograph conditions at that time. Availability in the U.S. market will also depend on manufacturers’ formulation and labeling cycles, but the company anticipates product launches could begin shortly after the final order is effective.
Closing the American Innovation Gap
If finalized, this milestone would officially recognize the ingredient as generally recognized as safe and effective (GRASE) for adults and children aged six months and older, expanding consumer choice, strengthening public health and advancing the fight against skin cancer across the United States. This milestone would also mark the first new UV filter introduced in the United States in over 25 years, closing a longstanding innovation gap for American consumers and public health.
Core advantages of Parsol Shield for the U.S. Sunscreen market and consumers:
- Outstanding broad-spectrum performance
- Unique holistic protection by closing a UVA coverage gap in the U.S. market
- Parsol Shield can be combined with any other UV filter
- Globally trusted and with environmental advantages, such as its state-of-the-art UV filter solution from a sustainability perspective
