DSM-Firmenich submitted the first Over-the-Counter Monograph Order Request (OMOR) Tier 1 application to the US Food and Drug Administration (FDA) for its sunscreen active ingredient, Parsol Shield, known under the USAN name Bemotrizinol. The move marks the official start of the FDA’s 17.5-months 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—the first update to the monograph since 1999.

A Global Innovation for Public Health and Skin Cancer Prevention

Parsol Shield provides broad-spectrum protection against both UVA and UVB radiation, renowned for its high photostability and superior efficacy at lower concentrations compared to other sunscreen actives. With over two decades of safe use in major markets such as Europe, Australia, and Asia, PARSOL® Shield has consistently demonstrated an outstanding safety profile.

If approved, Parsol Shield would become the first new sunscreen active ingredient added to the US OTC sunscreen monograph in nearly 25 years, setting a new standard for sun protection and significantly enhancing efforts to prevent skin cancer—the most common form of cancer in the US.

“This OMOR submission marks a monumental step in DSM-Firmenich’s commitment to driving innovation in sun care, consumer health, and sustainability,” said Parand Salmassinia, president of beauty & care, DSM-Firmenich. “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.”

What’s Next for BEMT?

The FDA now has a 17.5-month window to evaluate Parsol Shield safety and efficacy. If it meets GRASE criteria, Bemotrizinol will be incorporated into the US OTC sunscreen monograph, allowing its use in sunscreen formulations without the need for additional premarket approval.

DSM-Firmenich says it remains dedicated to collaborating closely with the FDA to provide all
required scientific and clinical data supporting BEMT’s safety and effectiveness. A successful GRASE determination will make Parsol Shield available to US consumers, delivering advanced sun protection technology that is already accessible in markets around the globe.