The Food and Drug Administration announced on Dec. 11 that it has formally proposed letting companies add bemotrizinol to sunscreen.
Data show the light filter protects against ultraviolet rays, is only absorbed into the body through the skin at low levels, and rarely causes skin irritation, the FDA said in its proposed order.
That includes data from clinical studies involving healthy adults, the FDA said in a scientific review of bemotrizinol’s efficacy and safety.
“Based on FDA’s review of the data on the efficacy of bemotrizinol, FDA tentatively concludes that there is adequate evidence of the efficacy of bemotrizinol for use as an active ingredient in nonprescription sunscreen drug products intended for use in adults and children 6 months of age and older,” regulators said….