The US Food and Drug Administration (FDA) is set to approve the use of DSM-Firmenich’s Parsol Shield UV filter for use in sun care products.
The agency said it is proposing to add bemotrizinol – the USAN nonproprietary name - as a permitted active ingredient for use in sunscreens.
Bemotrizinol has been approved across much of the world as an active ingredient in sunscreen, but not in the US.
The Swiss-Dutch company last year filed an Over-the-Counter Monograph Order Request (OMOR) that the FDA adds bemotrizinol, at concentrations up to 6 per cent, as a new active ingredient in the OTC monograph for sunscreens.
If approved, the FDA would allow bemotrizinol to be used in sunscreen formulations without the need for additional pre-market approval.
“Based on the data reviewed by the FDA, bemotrizinol provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation,” said the FDA.
“If this action is finalized, bemotrizinol will be an additional sunscreen active ingredient that the FDA considers to be generally recognized as safe and effective for use by adults and children six months of age and older, expanding consumer choice,” it added.
The FDA is currently seeking public comments on this proposed order.
If FDA concludes bemotrizinol is generally recognized as safe and effective as a sunscreen active ingredient, the agency will issue a final order to add the ingredient to OTC Monograph M020.
If approved, bemotrizinol would become the first new sunscreen active ingredient added to the US OTC sunscreen monograph since 1999.
The FDA admitted it has "historically moved too slowly" in the area of sun care ingredients, “leaving Americans with fewer options than consumers abroad”.
"We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” said FDA Commissioner Marty Makary.
“Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”
