ABSTRACT
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.
