PARSOL® Shield proposed FDA approval
dsm‑firmenich applauds the US Food and Drug Administration’s (FDA) 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 the supplier’s ingredient as ‘generally recognised as safe and effective’ (GRASE) for adults and children aged six months and older. This development expands consumer choice, strengthens public health and advances the fight against skin cancer across the US.
This proposal marks a historic milestone as it follows the first-ever Tier 1 OTC Monograph Order Request (OMOR) submitted to the FDA by dsm-firmenich. The request aims to amend OTC Monograph M020 and permit PARSOL® Shield at concentrations up to 6%.
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. The organisation called it a long-overdue step to expand ingredient options, enhance UV protection, and strengthen skin cancer prevention efforts.
“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, dsm-firmenich’s senior 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 photoageing – with aesthetics consumers love and global formulation chassis potential for faster, simpler launches,” says Dr Jochen Klock, director, global regulatory affairs beauty & care, dsm-firmenich.
Advancing public skin health
The FDA’s review highlights the outstanding UVB/UVA protection benefits of PARSOL® Shield along with its robust, clinically proven safety profile. This supports its potential designation as GRASE (starting at six months of age for topical use, pending final approval). This milestone would mark the first new UV filter introduced in the US 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 US market. This reinforces the company’s commitment to delivering safe, effective, and science-backed solutions for UV protection and skin cancer prevention.
Core advantages of PARSOL® Shield:
- Outstanding broad-spectrum performance.
- Unique holistic protection by closing a UVA coverage gap in the US market.
- Ideal for innovative, elegant sunscreen solutions.
- Compatible with any other UV filter, making it the most versatile sunscreen active on the market.
- Future-fit, globally trusted, and environmentally advantageous.
- A state-of-the-art UV filter solution from a sustainability perspective.
What happens next?
PARSOL® Shield enables new generations of sunscreens that will be loved by consumers. dsm-firmenich looks forward to the 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. It also 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 US market will also depend on manufacturers’ formulation and labelling cycles, but dsm-firmenich anticipates product launches could begin shortly after the final order is effective.
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