BRUSSELS (dpa-AFX) - DSM-Firmenich AG (DSFIR.AS) on Wednesday said the U.S. Food and Drug Administration (FDA) has approved bemotrizinol, marketed under the brand name PARSOL Shield, for use as a sunscreen ingredient.
The company said the approval marks the first new sunscreen active ingredient approved in the United States in more than 25 years under modernized GRASE (Generally Recognized as Safe and Effective) and MUsT (Maximal Usage Trial) evaluation guidelines.
Clinical studies involving nearly 500 participants representing the diversity of the U.S. population demonstrated strong UV protection, excellent tolerability and a favorable safety profile for PARSOL Shield.
PARSOL Shield is already approved in 58 countries, including the European Union, Canada, Australia, Japan, China, India and South Korea.
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