chapter  11
26 Pages

Regulations of Sunscreens Worldwide

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.