The purpose of this review was to provide an overview of the publicly available safety information for these ingredients needed to assess their suitability for use in therapeutic sunscreens listed on the ARTG. The findings will inform the need for any risk management actions to ensure public safety.
These ingredients were prioritised for this targeted review based on the availability of nonclinical safety data to TGA, their reported use in a higher number of sunscreen products marketed in Australia, and safety signals reported overseas. The literature includes available national and international safety assessment reports and peer reviewed publications.
The two main issues considered in this review were the evidence for the ability of these ingredients to penetrate the skin to reach viable cells systemically, and the potential toxicity exerted by them.