Regulations

DSM-Firmenich Submits OMOR Tier 1 Application for Parsol Shield to FDA

FDA's 17.5-month review clock is ticking for GRASE determination for the sunscreen active.

A sunscreen active moves closer to market.

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...

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