ABSTRACT
Overview of Regulations and Permitted UV Filters 174
Active Ingredients 175
The USA 175
Japan 175
EU Permitted Filters 176
Australian Approved UV Filters 176
Summary of Actives 176
Approval Process for New Active Ingredients 176
USA 176
Japan 181
European Union 182
Australia 182
Testing of Sunscreens 183
Reference Standards 183
USA 183
European Union 188
Japan 190
Australia 190
UV-A Tests 190
USA 190
European Union 190
Japan 191
Australia 192
Water Resistance Tests 192
USA 192
Australia 192
The Labeling of Sunscreens 193
USA 194
European Union 196
Australia 196
Japan 197
Manufacture of Sunscreens 197
Sunscreens are regulated throughout the world either as cosmetics or as over-
the-counter (OTC) drugs that do not require a governmental preapproval, or as
OTC drugs that require a preapproval before they are placed on the market.
Regardless of how they are regulated, all of these product regulations are very
similar concerning sunscreens! Each country has a preapproved list of permitted
UV filters, an accepted method of running efficacy by SPF determination, and
regulated labels. Some countries have approved methods for UV-A claims and
water-resistance testing.
