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Safety Threshold Considerations for Sunscreen Systemic Exposure: A Simulation Study
Author(s) -
Wang Jian,
Ganley Charles J.
Publication year - 2019
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1178
Subject(s) - systemic circulation , food and drug administration , medicine , drug , pharmacokinetics , absorption (acoustics) , systemic risk , systemic reaction , pharmacology , allergy , immunology , physics , financial crisis , acoustics , economics , macroeconomics
Sunscreens are regulated as over‐the‐counter drugs in the United States. Some sunscreen ingredients are absorbed into the systemic circulation, which raises concerns about the safety of these drugs. There is limited information on the systemic exposure for most sunscreen ingredients. This report estimates the systemic absorption of two sunscreen active ingredients, oxybenzone and enzacamene, by developing a pharmacokinetic model from published sunscreen absorption data and compares the results with safety thresholds proposed by the US Food and Drug Administration and in the literature. Our analysis indicates that systemic absorption can be substantial, and evaluation of the systemic exposure of sunscreen ingredients is warranted to better assess any long‐term risks of use.