![]() PWHD is investigating cases involving personal injury or death as a result of benzene contamination of certain sunscreen products. Christopher Bunick, MD, PhD, Associate Professor of Dermatology at Yale University, New Haven, CT). Valisure® Petition, at 17 (quoting Email from Dr. The total mass of sunscreen required to cover and protect the human body, in single daily application or repeated applications daily, means that even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.” “Considering that human skin has a large total surface area (~1.85 m2), and that ~28.5 g of sunscreen is needed per application to properly cover that skin surface, it follows then that there is not a safe level of benzene that can exist in sunscreen products. Though most were sprays, they also included lotions and gels.Īs one clinician and researcher from Yale commented: The majority of these were Neutrogena branded sunscreen, but they also include Banana Boat, CVS Health, SunBurnt, Goodsense, Raw Elements, TopCare Everyday, and EltaMD branded products. Twenty-six additional sunscreen products contained benzene contamination from 0.1 ppm to 2 ppm. Thirteen of these products were spray products, while the one Fruit of the Earth product was a gel. Ten of these products were sold under the Neutrogena brand, two were sold under the CVS Health brand, and one each were sold under the Sun Bum and Fruit of the Earth brands. Valisure’s citizen’s petition to the FDA revealed that fourteen different sunscreen products had benzene contamination exceeding 2 ppm. Valisure® also found that some sunscreens have no benzene contamination whatsoever, meaning that benzene apparently is not a necessary ingredient for sunscreen and there are reasonable and feasible alternatives. Valisure® found that some of the sunscreen products tested had levels of benzene that surpassing 2 ppm or “over 400 times the threshold for systemic carcinogenicity assessment for at least one sunscreen active ingredient.” Valisure® Citizen Petition to FDA, at 2 (hereinafter Valisure® Petition). The National Institute for Occupational Safety and Health (NIOSH) recommends that workers working with benzene wear protective equipment if they expect to be exposed to concentrations in excess of 0.1 parts per million (ppm). The FDA likewise recognizes the high danger of benzene and lists it as a “Class 1 solvent” that should not be employed in the manufacture of drug substances and products because of its unacceptable proximity. The toxicity of benzene has been known since at least 1897 and the International Agency for Research On Cancer (“IARC”) has classified benzene as a Group 1 human carcinogen that has been linked to the development of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma, and non-Hodgkin lymphoma. Benzene is typically a byproduct of oil, gasoline, and other volatile substances and processes.
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