1/16/2024 0 Comments Benzene in sunscreen![]() ![]() Benzene was detected in many sunscreen and after-sun care products, and Valisure notified the FDA through a citizen petition filed on. To determine the scope of the potential problem, Valisure LLC (hereinafter Valisure) followed up with a market assessment of commonly available sun care products by independently sourcing and testing different brands and formulations. However, benzene at any concentration in consumer products could pose a risk to consumers and the environment.īenzene was first detected during routine testing in two sunscreen products. 6, 7 For purposes of this study, concentrations greater than 2.0 ppm and concentrations of 0.1 ppm – 2.0 ppm are used as brackets of concern. 2 As stated in a 2010 review of benzene health effects, “…ll exposures constitute some risk in a linear, if not supralinear, and additive fashion.” 5 Furthermore, benzene exposure, whether occupational or infrequent and from a variety of environmental sources, has been linked to blood cancers. The National Institute for Occupational Safety and Health recommends that workers who are expected to be exposed to benzene at concentrations 0.1 ppm or above for 10 h, or 1 ppm for 15 min, wear protective equipment. In all other cases, which ostensibly include sunscreens, FDA guidance is to avoid benzene altogether. ![]() Benzene is restricted by the FDA to 2 parts per million (ppm) only in cases where its use in manufacturing is unavoidable and the drug product constitutes a significant therapeutic advance. Other topical products, such as those used after sun exposure, are typically regulated in the United States as cosmetics under the Federal Food, Drug, and Cosmetic Act (FDCA) and Fair Packaging and Labeling Act. Food and Drug Administration (FDA) as active pharmaceutical ingredients (API), rendering sunscreens as regulated drug products. 4 Chemical UV-blocking agents, including avobenzone, oxybenzone, octisalate, octinoxate, homosalate, octocrylene, and physical UV-blocking agents, including zinc oxide, are regulated by the U.S. 3 Consumers can choose from many sunscreen formulations, including lotions and aerosol sprays, and it is estimated that more than 11,000 different sunscreen products are registered in the United States. Health care professionals recommend sunscreen to prevent skin cancer, and reapplication is recommended every hour, which is more frequent than recommendations in most package directions. 1 Even in trace amounts, benzene is known to pose a health risk from exposure routes that include inhalation, ingestion, dermal absorption, and skin or eye contact. Benzene is a well-documented Group 1 carcinogen and environmental hazard. ![]()
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