Last Updated on May 10, 2022 by Ithos Global Regulatory Team
Pharmaceutical testing company Valisure has asked the FDA to recall 40 different lots of sun products from 10 different brands after benzene, an FDA class 1 carcinogenic solvent, was found in the formulas, though the substance is not intentionally added to sunscreens.
The testing company reported that 27% of samples tested contained detectable benzene and some batches contained up to three times the conditionally restricted FDA concentration limit of 2 parts per million (ppm).
The testing company has also re-petitioned the agency to better control benzene in drugs and cosmetics.
This is not the first time Valisure tested products for benzene contamination. Earlier this year, the company found evidence of the substance in several batches in multiple brands of hand sanitizer. They also issued a request to the FDA to recall the contaminated batches and to update its guidance to include an exposure limit for benzene.