Based on data reviewed by the US FDA, this ingredient provides protection against both UV A and B rays, has low levels of absorption through the skin and rarely causes skin irritation. If the action is finalized, Bemotrizinol will be an additional sunscreen active ingredient that the US FDA considers generally recognized as safe and effective (GRASE) for use by adults and children 6 months of age and older, expanding consumer choice.
Bemotrizinol at £ 6% is currently listed in the Canadian Primary Sunscreen monograph with certain conditions/combinations. Given the Canadian Primary and Secondary Sunscreen Monographs are currently under revision, we have made representations to the NNHPD around the inclusion of bemotrizinol in the secondary sunscreen monograph. These two monographs are expected updated and to be published in the coming days.
Within this context, DSM Nutritional Products LLC submitted a request that the FDA add bemotrizinol, at concentrations up to 6 percent, as a new active ingredient in the OTC monograph for sunscreens. While bemotrizinol has been marketed as a sunscreen ingredient in many countries, the FDA has not previously approved an application for a drug product containing bemotrizinol nor added it to the sunscreen monograph.
The FDA is seeking public comments on this proposed order.
