Including Oxybenzone, Octinoxate On US Sunscreen Monograph Could Swing On Environmental Impact
FDA will prepare an environmental impact statement on sunscreen ingredients oxybenzone and octinoxate in light of questions on the ingredients’ impact on coral and coral reefs. It plans to complete the review prior to publishing final order for its OTC sunscreen ingredients monograph.
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The Public Access to Sunscreens Coalition suggests the FDA should stay in its regulatory lane or at least await the results of a National Academies of Sciences study before moving forward with an environmental impact statement to the US Environmental Protection Agency regarding certain UV filters under GRASE review reported to harm marine coral.
Industry anticipates a proposed administrative order from the US FDA by 27 September on OTC sunscreen drug products, including GRASE status of active ingredients. Meanwhile, the agency’s probe continues into UV filter environmental impacts, and the National Academy of Sciences is gathering information to weigh those possible ills against human health consequences of reduced sunscreen use.
Independent lab's analysis found benzene levels at “up to three times the conditionally restricted FDA concentration limit of 2 ppm" in 10 Neutrogena sunscreen formulations.