FDA reviewing application for bemotrizinol as first new sunscreen ingredient since 1999

Key takeaways:

• Bemotrizinol has been approved across most regions worldwide, but not in the U.S.
• If approved by the FDA, it will be the first sunscreen ingredient added to the monograph in nearly 25 years.

The first over-the-counter monograph order request tier 1 application for bemotrizinol, an active sunscreen ingredient, has been submitted to the FDA, dsm-firmenich announced in a press release.

Marketed as PARSOL Shield and developed by dsm-firmenich, bemotrizinol has been approved across much of the world as an active ingredient in sunscreen, but not in the United States.

“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,” Parad Salmassinia, JD, president of beauty and care at dsm-firmenich, said in the release. “If approved, it will elevate the standard of sun protection and play a vital role in public health and skin cancer prevention.”

The FDA has 17.5 months to review the application, after which the agency will make its decision on whether bemotrizinol will be considered generally recognized as safe and effective.

If approved, bemotrizinol will be added to the U.S. OTC sunscreen monograph, making it the first new active sunscreen ingredient added since 1999.