ABSTRACT
Requirements for Safety Testing of Sunscreens 55
Parameters Affecting Sunscreen Safety 56
Safety Programs Required for Sunscreen Products 57
Safety Testing Models for Sunscreen Products 58
In Vitro Models 59
In Vivo Dermal Safety Testing in Animals 61
In Vivo Systemic Safety Testing in Animals 64
In Vivo Dermal and Systemic Safety Testing in Humans 65
Risk Assessment and Safety Testing of Sunscreens 67
Conclusion 67
References 68
REQUIREMENTS FOR SAFETY TESTING OF SUNSCREENS
In the USA, sunscreens are classified as drugs based on their ability to prevent
injury to the skin after exposure to ultraviolet radiation (UVR). Because of
their proven safety and ease of use by consumers, the Food and Drug Adminis-
tration (FDA) has allowed them to be marketed over the counter (OTC), provided
they comply with the OTC monograph specifying active ingredients,
concentrations, use, and labeling (1). These criteria are based upon safety and
efficacy data submitted by industry during the sunscreen monograph develop-
ment process initiated back in 1972. The 1978 Tentative Final Monograph
listed 21 ingredients, which changed to the current list of 16 with the 1996
approval of the New Drug Application (NDA) for avobenzone (2).
