chapter  9
14 Pages

Regulation of Sunscreens in Australia

Introduction 128

The Regulatory Framework 129

Test Methods 131

The Listing Process 132

New Chemicals 132

New Excipients (Nonactive Ingredients) 132

New Sunscreen Actives 133

Permitted Sunscreens Actives and their Maximum Allowed Dosages 135

Sunscreens Actives under Review 136

Licensing of Premises 136

Labeling of Sunscreens 137

Mandatory Requirements for Primary Sunscreens 137

Optional Requirements for Primary Sunscreens 137

Mandatory Requirements for Secondary Sunscreens 138

Optional Requirements for Secondary Sunscreens 138

Advertising of Sunscreens 138

The Cosmetic/Therapeutic Interface 139 Example 1 139

Example 2 139

Conclusions 140

INTRODUCTION

Sunscreens are regulated as therapeutic goods in Australia. Given Australia’s

claim to have the highest incidence of skin cancer in the world, this seems

very reasonable. People from countries where UV-B radiation is less intense

and of shorter duration may consider this unnecessary; however, Australians

well understand the need to protect skin against sun exposure and they expect

their interests to be properly protected by the implementation of appropriate

controls of the quality of the sunscreens they buy and use. This is best achieved

in Australia by dealing with sunscreens as therapeutic goods.