Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients

Author:

Matta Murali K.1,Zusterzeel Robbert1,Pilli Nageswara R.1,Patel Vikram1,Volpe Donna A.1,Florian Jeffry1,Oh Luke2,Bashaw Edward2,Zineh Issam2,Sanabria Carlos3,Kemp Sarah3,Godfrey Anthony3,Adah Steven4,Coelho Sergio4,Wang Jian5,Furlong Lesley-Anne5,Ganley Charles5,Michele Theresa4,Strauss David G.1

Affiliation:

1. Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland

2. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland

3. Spaulding Clinical Research, West Bend, Wisconsin

4. Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland

5. Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland

Publisher

American Medical Association (AMA)

Subject

General Medicine

Reference21 articles.

1. Labeling and effectiveness testing: sunscreen drug products for over-the-counter human use: final rule.;US Food and Drug Administration, HHS;Fed Regist,2011

2. Human safety and efficacy of ultraviolet filters and sunscreen products.;Nash;Dermatol Clin,2006

3. Safety threshold considerations for sunscreen systemic exposure: a simulation study.;Wang;Clin Pharmacol Ther,2019

4. Sunscreen drug products for over-the-counter human use: proposed rule.;US Food and Drug Administration (FDA);Fed Regist,2019

5. Maximal usage trial: an overview of the design of systemic bioavailability trial for topical dermatological products.;Bashaw;Ther Innov Regul Sci,2015

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