In Australia, sunscreen is classified as a primary sunscreen or a secondary sunscreen depending on the SPF index. If it is classified as a medical product according to the performance of sunscreen, it is subject to TGA regulation, and if it is classified as a cosmetic, it is subject to AICIS regulation.
Australia's Therapeutic Goods Administration (TGA) has announced updated requirements for sunscreens as of June 14, 2024, through the revised <2024 Measures No.2>. This applies efficacy testing and labeling requirements for sunscreen products sold as therapeutic products in existing Australia.
This is necessary to ensure that such products are tested to International Organization for Standardization (ISO) standards and adequately protect users from the harmful effects of ultraviolet (UV) radiation, and that users are instructed on the correct way to apply certain sunscreens (i.e., sunscreen aerosols and spray pump packs).
Table item 7 of Schedule 4 sets out the eligibility criteria that therapeutic sunscreens must meet as a registered material.
l Item [2] – Schedule 4 (table item 7, column headed “Therapeutic goods”, paragraph (a))
: This item replaces the reference to the 2012 Standard in paragraph (a) of table item 7 with a reference to the ‘Australian/New Zealand Standard AS/NZS 2604:2021, Sunscreen products – Evaluation and classification, published jointly by, or on behalf of, Standards Australia and Standards New Zealand’ (the new Standard).
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