AICIS Updates Guidance on Cosmetics with Sunscreens

People often ask, “Who is responsible for regulating the introduction of cosmetics that contain sunscreen in Australia”. The answer depends on whether the product meets the legal definition of a ‘therapeutic’ or a ‘cosmetic’. The TGA is the responsible regulator for all primary sunscreens (products used primarily for protection from UV radiation that have a rated sun protection factor (SPF) of 4 or more); some secondary sunscreens - such as moisturisers that contain sunscreen with an SPF greater than 15; sunscreens with an SPF of 4 or more that contain an insect repellent; and, sunscreens with specific ingredients listed in Schedule 5 of the Therapeutic Goods Regulations 1990. AICIS (previously NICNAS) is the responsible regulator for products applied to the lips (such as lipsticks and lip balms) that contain sunscreen with an SPF of 4 or more; tinted bases and foundations (including liquids, pastes and powders) that contain sunscreen with an SPF of 4 or more; moisturising skin-care products that contain sunscreen with an SPF of 15 or less, that are in a pack size no larger than 300 ml or 300 g; and, sunbathing skin-care products with sunscreen that contain an SPF between 4 and 15, and are in a pack size no larger than 300 ml or 300 g.    Source: Cosmetic sunscreens

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