DSM-Firmenich has filed paperwork with the US Food and Drug Administration (FDA) seeking approval for its sunscreen active ingredient, Parsol Shield.
The Swiss-Dutch company has submitted an Over-the-Counter Monograph Order Request (OMOR) Tier 1 application for the ingredient known under the USAN name Bemotrizinol.
The long-awaited move marks the start of the FDA’s 17.5-month review process to determine whether Bemotrizinol will be classified as Generally Recognized as Safe and Effective (GRASE) for inclusion in the US OTC sunscreen monograph.
If approved, Bemotrizinol would become the first new sunscreen active ingredient added to the US OTC sunscreen monograph since 1999.
In turn, that would allow Bemotrizinol to be used in sunscreen formulations without the need for additional pre-market approval.
Bemotrizinol, approved in most regions worldwide and in use since 2000, is the first sunscreen active ingredient to undergo review under the FDA’s updated safety and efficacy standards.
“This OMOR submission marks a monumental step in our commitment to driving innovation in sun care, consumer health, and sustainability,” said DSM-Firmenich President of Beauty & Care Parand Salmassinia.
“Parsol Shield has been safely used worldwide for over 20 years, and we are proud to lead the introduction of this proven technology to US consumers. If approved, it will elevate the standard of sun protection and play a vital role in public health and skin cancer prevention,” she added.
