dsm-firmenich’s PARSOL Shield marks major milestone with FDA submission for OTC sunscreen monograph



In a exciting move for the US personal care and cosmetics industry, dsm-firmenich has submitted the first-ever 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 as Bemotrizinol (BEMT). This submission initiates a 17.5-month review by the FDA to determine whether BEMT will be classified as Generally Recognized as Safe and Effective (GRASE), potentially becoming the first sunscreen active ingredient to be added to the US OTC sunscreen monograph in nearly 25 years, according to the company’s press release. 

The FDA’s decision could have far-reaching implications for cosmetics and personal care product manufacturers, offering them a new, high-performance UV filter that has been widely used in other global markets since 2000. For manufacturers and suppliers, the introduction of PARSOL Shield in the US could significantly enhance product offerings by incorporating a globally proven sunscreen ingredient with advanced photostability and broad-spectrum coverage.

A rigorous FDA submission process

dsm-firmenich’s Ruiz shared details about the data supporting the safety and effectiveness of PARSOL Shield. “DSM conducted the relevant studies, trials, and gathered supporting data for the proposed monograph change under a  confidential Investigation New Drug (IND) application,” he said.

He noted that the OMOR Tier 1 submission followed the FDA’s 2023 guidelines and included extensive pharmacological, clinical, and toxicological information required for the GRASE determination, “including those outlined in ‘Nonprescription Sunscreen Drug Products’ and ‘Guidance on Maximal Usage Trials’ (MUsT).” 



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