dsm‑firmenich applauds the US Food and Drug Administration’s proposal to include PARSOL Shield, at a maximum concentration of 6%, as an approved active ingredient in over‑the‑counter (OTC) sunscreens in the United States. If finalised, this milestone would officially recognise our ingredient as generally recognised 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 U.S.
This proposal marks a historic milestone as it follows the first-ever Tier 1 OTC Monograph Order Request (OMOR) to be submitted to FDA – by dsm-firmenich - to amend OTC Monograph M020 and permit PARSOL Shield at concentrations up to 6%.
PARSOL® Shield. Sun Protection. Redefined.
dsm-firmenich was pleased to see the American Academy of Dermatology’s press release commenting on the FDA’s proposal to approve PARSOL Shield for US sunscreens, calling it a long-overdue step to expand ingredient options, enhance UV protection, and strengthen skin cancer prevention efforts. FDA Proposes First New Sunscreen Filter in 26 Years.
“This is an incredible win for American public health and skin cancer prevention! The FDA’s proposal is a major milestone for American consumers and our brand partners.“ said Carl D’Ruiz, Sr Business Development Manager, Beauty & Care North America.
“PARSOL Shield is designed to deliver broad-spectrum UVB/ UVA performance even at low levels, helping protect against sun induced skin damage, skin cancer and premature photoaging—with aesthetics consumers love and global formulation chassis potential for faster, simpler launches.” said Dr Jochen Klock, Director, Global Regulatory Affairs Beauty & Care.
Advancing public skin health
The FDA’s review highlight PARSOL Shield’s outstanding UVB/UVA protection with a robust clinically proven safety profile. All that supports its potential designation as GRASE (Generally Recognised as Safe and Effective) for use starting at six months of age, pending final approval. This milestone would mark the first new UV filter introduced in the U.S. in over 25 years, closing a longstanding innovation gap for American consumers and public health.
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 our commitment to delivering safe, effective, and science-backed solutions for UV protection and skin cancer prevention.
Core advantages of PARSOL Shield for the US Sunscreen market and consumers
- Outstanding broad spectrum performance.
- Unique holistic protection by closing a UVA coverage gap in the US market
- Ideal for innovative, elegant sunscreen solutions – PARSOL Shield can be combined with any other UV filter which makes it the most compatible sunscreen active in the market.
- Future fit, globally trusted & with environmental advantages – state-of-the-art UV filter solution from sustainability perspective.
- Enabling new generations of sunscreens that will be loved by consumers.
What happens next
dsm-firmenich looks forward to FDA’s addition of PARSOL Shield at 6% as a GRASE active ingredient to the OTC sunscreen monograph via its OMOR Tier 1 regulatory approval process and 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 labelling cycles, but we anticipate product launches could begin shortly after the final order is effective.
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