chapter  4
16 Pages

Safety Considerations for Sunscreens in the USA

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


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).