![]() Link to reviewįDA currently recognizes the serious danger of benzene and lists it as a “ Class 1 solvent” that “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity…However, if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted” and benzene is restricted to 2 ppm for these special circumstances. Valisure is accepting sunscreen products for analysis at no cost: Sunscreen Crowdsourcing Study LinkĬ has published a review for its members of the Valisure data suggesting products to avoid and which might be safest with regard to the benzene results. Valisure’s FDA Citizen Petition: Complete Valisure’s FDA Citizen Petition on Sun Care Products (All attachments and other resources linked below.) It is important to note that not all sunscreen products contain benzene and that uncontaminated products are available, should continue to be used, and are important for protecting against potentially harmful solar radiation. ![]() Valisure is asking for a recall of the contaminated batches and requesting FDA better define limits for benzene contamination in drug and cosmetic products. 27% of samples tested by Valisure contained detectable benzene and some batches contained up to three times the conditionally restricted FDA concentration limit of 2 parts per million (ppm). The National Institute for Occupational Safety and Health (NIOSH) defines benzene as a carcinogen and lists “inhalation, skin absorption, ingestion, skin and/or eye contact” as exposure routes. Department of Health and Human Services, the World Health Organization, and other regulatory agencies. Centers for Disease Control and Prevention, the U.S. Benzene is known to cause cancer in humans according to the U.S. NEW HAVEN, CT – – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which are generally regulated by FDA as cosmetics. VALISURE DETECTS HIGH LEVELS OF KNOWN HUMAN CARCINOGEN BENZENE IN SEVERAL SUNSCREEN PRODUCTS AND REQUESTS FDA ACTIONS 78 sunscreen and after-sun care products contained benzene, an industrial chemical known to cause cancer and other potentially serious health risks
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