PhD US Food and Drug Administration Silver Spring, Maryland
Sunscreen safety is part of FDA’s larger mission to protect public health and ensure drug safety. Sunscreen products containing single or multiple active ingredients are formulated to act locally following dermal application to protect the skin from UV damage. However, clinical studies conducted by the FDA found that certain sunscreen active ingredients led to systemic absorption. Therefore, FDA is considering final formulation testing to address potential sunscreen active ingredient absorption before marketing new products (Proposed Order (OTC000008): Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for OTC Human Use). This presentation will give an overview of FDA internal studies on sunscreens, including in vitro studies, in vitro-in vivo correlations, and critical quality attributes that affect the absorption of sunscreen active ingredients. These studies will highlight what to consider when conducting sunscreen product development, in order to shorten the development time required to market safe and effective sunscreens for millions of users.
Learning Objectives:
Upon completion, participant will be able to understand FDA's current thinking and methods in evaluating sunscreen products containing sunscreen active ingredients.
Upon completion, participant will be able to know whether long term storage of sunscreen could affect sunscreen skin absorption.
Upon completion, participant will be able to know available guidance and regulations on sunscreen products.