Press Release
October 1, 2024
FDA’s 17.5-Month Review Clock Begins for GRASE Determination September 23, 2024.
Kaiseraugst (CH), 1 October 2024
FDA’s 17.5-Months Review Clock Begins for GRASE Determination September 23, 2024
As innovators in nutrition, health, and beauty, dsm-firmenich, is thrilled to announce the submission of the first-ever Over-the-Counter Monograph Order Request (OMOR) Tier 1 application to the U.S. Food and Drug Administration (FDA) for its high-performance sunscreen active ingredient, PARSOL® Shield, known under the USAN name Bemotrizinol.
This marks a significant milestone, as it officially starts 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 U.S. OTC sunscreen monograph—the first update to the monograph since 1999.
PARSOL® Shield, globally marketed by dsm-firmenich, is approved in most regions worldwide and has been used safely since 2000. It is now the first sunscreen active ingredient to undergo review under the FDA’s updated safety and efficacy standards. This represents a landmark moment for both the skincare and suncare industries in the U.S.
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 U.S. 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 U.S.
“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 at 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 U.S. 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?
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 U.S. OTC sunscreen monograph, allowing its use in sunscreen formulations without the need for additional pre-market approval.
dsm-firmenich remains dedicated to collaborating closely with the FDA to provide all required scientific and clinical data supporting Bemotrizinol’s (BEMT) safety and effectiveness. A successful GRASE determination will make PARSOL® Shield available to U.S. consumers, delivering advanced sun protection technology that is already accessible in markets around the globe.
dsm-firmenich Beauty & Care
A House of Science beyond Wellbeing.
For more information
Jochen Klock, PhD
Head of Global Regulatory Affairs Beauty & Care
Jochen.Klock@dsm-firmenich.com
Carl D’Ruiz, MPH
Senior Regulatory and Business Development Manager
Carl.D-Ruiz@dsm-firmenich.com
About dsm-firmenich
As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion.
www.dsm-firmenich.com
www.dsm-firmenich.com/en/businesses/perfumery-beauty/beauty-care
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