Medicine or Cosmetic? Getting Sunscreen Classification Right Before Testing Begins
In Australia, most sunscreens are medicines. Dr Leslie Laquieze explains why the classification decision must come first, and how the 2021 Sunscreen Standard and its transition rules shape every dossier.
By Dr Leslie Laquieze, PharmD, MSc, PhD, MBA, Expert Member, Australian Sunscreen Council
A sunscreen can look like a cosmetic, feel like a cosmetic and sit on a cosmetics shelf, yet still be regulated as a medicine. In Australia, the testing plan cannot be designed until the product’s regulatory status has been settled. Classification is therefore the first technical decision in any sunscreen programme, not an administrative formality at the end.
Therapeutic and excluded sunscreens
The Therapeutic Goods Administration explains on its page Sunscreen regulation in Australia that therapeutic sunscreens include “primary sunscreens: products that are represented as being primarily to protect the skin from ultraviolet (UV) radiation,” and some secondary sunscreen products, “for example, sunbathing and moisturising skin care products with an SPF of over 15.” The same page states that “generally, therapeutic sunscreens must be in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied or sold in Australia,” and that they “are generally regulated under the listed medicines framework and have an AUST L number on the label.”
Some secondary sunscreens are excluded from therapeutic goods legislation under the Therapeutic Goods (Excluded Goods) Determination 2018. According to the TGA, these include lip products and tinted bases and foundations with SPF 4 or more, and moisturising and sunbathing skincare products in packs no larger than 300 mL or 300 g with an SPF between 4 and 15 that are not presented as water resistant and do not make therapeutic claims such as claims about skin cancer.
Listing is not the same as approval. The TGA states that “listed therapeutic sunscreens are not premarket evaluated by us, but the sponsor must legally certify when they list their product that it meets all applicable legislative requirements in relation to safety, quality and efficacy.” The responsibility for evidence therefore sits squarely with the sponsor.
Safety is the sponsor’s responsibility
The TGA is explicit that responsibility for the safety of a listed sunscreen rests with its sponsor. Its guidance Listed medicines information for new sponsors states: “We don’t evaluate listed medicines individually for safety, quality and efficacy (effectiveness) before they go onto the market.” Its page on certifying listed medicines adds that “sponsors must certify the safety, quality and efficacy of their listed medicine” and that “listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are supplied in the marketplace.”
An AUST L number therefore records that the sponsor has certified the product. It does not mean that the TGA has checked the product’s safety, and it is not an assurance of safety from the TGA. The TGA may review products after they reach the market, but in the author’s opinion neither sponsors nor consumers should read ARTG listing as a regulator’s safety guarantee. Every sponsor should hold its own evidence that the finished product is safe for its intended use.
What sponsors should document
· The classification rationale and the identity of the responsible Australian sponsor.
· A map of every indication and advertising statement to the evidence held at inclusion and throughout the product’s life.
· The applicable GMP, labelling, advertising, pharmacovigilance and ARTG maintenance obligations.
· For a cosmetic secondary sunscreen, a formal confirmation that the exclusion criteria are met. Cosmetic presentation alone is not sufficient.
The 2021 Sunscreen Standard and its transition
The legal anchor for sunscreen testing is AS/NZS 2604, Sunscreen products – Evaluation and classification. The TGA’s page Updates to the Sunscreen Standard sets out the transition:
· “From 1 July 2024, all new sunscreen products included in the Australian Register of Therapeutic Goods (ARTG) must comply with the 2021 Sunscreen Standard.”
· “All existing sunscreens products (aerosol and non-aerosol) included in the ARTG prior to 1 July 2024 will have a 5-year transition period where they can comply with the testing requirements of the 2021 Sunscreen Standard or previous standard (2604:2012).”
· “Existing aerosols and spray pump packs included in the ARTG prior to 1 July 2024 will have a 1-year transition period to comply with the new labelling requirements in the 2021 Sunscreen Standard.”
· “After the transition period, all existing sunscreen products included in the ARTG and any new products released for supply must comply the 2021 Sunscreen Standard.”
The edition incorporated by reference is AS/NZS 2604:2021 Amd 1:2022. In practical terms, products listed before 1 July 2024 have until mid-2029 to move fully to the 2021 edition. That deadline should not be left to the final year, because laboratory capacity is limited and retesting may reveal performance gaps that require reformulation.
What changed in the 2021 edition
The TGA’s 2024 paper on the proposed adoption of AS/NZS 2604:2021 describes the revision as one that “completes the transition of methods for determining broad spectrum, SPF and water resistance from local Australian and New Zealand test methods to globally written, agreed and published ISO standards.” It notes that ISO 24444:2019 replaced the 2010 in-vivo SPF method, ISO 24443:2021 replaced the 2012 UVA method with the addition of a critical wavelength calculation and pre-irradiation to account for photostability, and water immersion now follows ISO 16217:2020. Importantly, the paper states that “Australia and New Zealand still retain the 4 h water resistance test period and claim and, continue to determine SPF after immersion as the SPF value to use for labelling SPFs.”
Reform on the horizon for cosmetic sunscreens
Classification may become more demanding. The TGA’s March 2026 consultation paper on improving sunscreen regulation notes that current provisions exclude tinted bases, foundations and lip products with SPF claims up to SPF 50+. It canvasses options to require excluded products to carry the words “cosmetic sunscreen” on the primary label, or to limit all excluded secondary sunscreens to “low” SPF protection claims. No decision had been announced as at the date of this article.
Company action
Maintain a controlled record for each ARTG entry showing the inclusion date, the edition of AS/NZS 2604 relied upon, the linked test reports, the gaps still to close and an internal migration deadline. For every cosmetic sunscreen, record the exclusion criteria relied upon and set a review point for when the TGA’s reform decisions are published.
Sources
· Therapeutic Goods Administration, “Sunscreen regulation in Australia”: https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/overview/sunscreen-regulation-australia
· Therapeutic Goods Administration, “Listed medicines information for new sponsors”: https://www.tga.gov.au/products/medicines/listed-medicines/overview/listed-medicines-information-new-sponsors
· Therapeutic Goods Administration, “Certifying that your listed or assessed listed medicines meet all regulatory requirements”: https://www.tga.gov.au/products/medicines/listed-medicines/application-and-market-authorisation/certifying-your-listed-or-assessed-listed-medicines-meet-all-regulatory-requirements
· Therapeutic Goods Administration, “Updates to the Sunscreen Standard”: https://www.tga.gov.au/products/medicines/non-prescription-medicines/supply-non-prescription-medicine/manufacturing-requirements-and-standards-non-prescription-medicines/standards-non-prescription-medicines/updates-sunscreen-standard
· Therapeutic Goods Administration, “Proposed adoption of the Australian/New Zealand Sunscreen Standard AS/NZS 2604:2021”, April 2024: https://www.tga.gov.au/sites/default/files/2024-04/proposed-adoption-the-australian-new-zealand-sunscreen-standard-as-nzs-26042021.pdf
· Therapeutic Goods Administration, “Seeking feedback on improvements to the regulation of sunscreens in Australia”, consultation paper, March 2026: https://consultations.tga.gov.au/tga/improvements-to-regulation-of-sunscreens-in-aus/user_uploads/final---consultation---seeking-feedback-on-improvements-to-the-regulation-of-sunscreens-in-australia---v1-march-2026-2.pdf
About the Author
Dr Leslie Laquieze (PharmD, MSc, PhD, MBA) is a pharmacist-scientist and international expert in sunscreen testing, photoprotection, skin pharmacology and dermocosmetic claim substantiation. An expert member of the Australian Sunscreen Council, she has led Kosmoscience Europe since 2018, supporting the evaluation, substantiation and regulatory positioning of cosmetic and dermatological products across international markets.
This article reflects the opinion of Dr Leslie Laquieze. Readers are recommended to seek expert legal advice on all issues discussed.
