DSM-Firmenich has hailed the US Food and Drug Administration’s proposal to approve its Parsol Shield UV filter as an active ingredient in sunscreens as a victory for consumers.
The Swiss-Dutch company anticipates that the FDA will issue a final order by June 2026, after which Parsol Shield would benefit from an 18-month exclusivity in the US market as sponsor of the Tier 1 OTC Monograph Order Request (OMOR).
On 11 December, the FDA said it would approve bemotrizinol – the USAN nonproprietary name for the UV filter - at concentrations up to 6 per cent in over the counter (OTC) sunscreens.
The filter is an oil-soluble organic compound that provides low-level skin absorption and provides broad spectrum protection to absorb UV rays, absorbing both UVB and UVA rays.
The proposed filter has already been approved in Europe since 2000.
If approved by the FDA, bemotrizinol would become the first new sunscreen active ingredient added to the US OTC sunscreen monograph since 1999.
It would be the third sunscreen active ingredient - in addition to zinc oxide and titanium dioxide - to be generally recognized as safe and effective for use by adults and children six months of age and older.
DSM-Firmenich said, if finalized, this milestone would expand consumer choice, strength public health, and advance the fight against skin cancer across the US.
“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,” added Carl D’Ruiz, senior business development manager, Beauty & Care North America.
Dr. Jochen Klock, Director, Global Regulatory Affairs Beauty & Care, added: “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.”
Meanwhile, the American Academy of Dermatology Association said the addition of bemotrizinol to the list of permitted sunscreen ingredients would greatly benefit US public health.
"The Academy hopes this proposed sunscreen filter is an indicator that the FDA is poised to move forward with lagging approvals of innovative and new sunscreen ingredients – many of which are available to consumers abroad – that will help save the lives of Americans from skin cancer," it added.
