About sunscreen regulation
Sunscreens classified as therapeutic goods (therapeutic sunscreens) are regulated by the TGA. Unless exempt, therapeutic sunscreens must be included in the Australian Register of Therapeutic Goods (ARTG) before they can legally be marketed in Australia. Therapeutic sunscreens include:
- Primary sunscreens: Products that are used primarily for protection from UV radiation.
- Some secondary sunscreens: Products with a primary purpose other than sun protection, but which also contain sun screening agents.
Many secondary sunscreen products, such as cosmetic sunscreens, are not considered to be therapeutic goods and are 'excluded' from therapeutic goods legislation.
Sunscreens not required to be included in the ARTG
The secondary sunscreen products that are 'excluded' from therapeutic goods legislation under the Therapeutic Goods (Excluded Goods) Determination 2018 (Excluded Goods Determination) include products that are used, advertised or presented for supply in the following ways:
- Products intended for application to the lips with sunscreen if the Sun Protection Factor (SPF) is 4 or more.
- Tinted bases and foundations (such as liquids, pastes or powders) with sunscreen if the SPF is 4 or more.
- Moisturising skin care products for dermal application (including anti-wrinkle, anti-aging and skin whitening products) in a pack size not larger than 300 mL or 300 g, with sunscreen if the SPF is between 4 and 15.
- Sunbathing skin care products (such as oils, creams, gels, tanning products without sun, and after-sun care products) in a pack size not larger than 300 mL or 300 g, with an SPF between 4 and 15.
Excluded sunscreen products are not required to be included in the ARTG and are not required to comply with standards applicable to therapeutic goods. For information on the regulatory requirements for these products refer to:
- The Australian Industrial Chemicals Introduction Scheme which is responsible for the manufacture and importation of industrial chemicals including ingredients used in cosmetic sunscreens.
- The Australian Competition and Consumer Commission which is responsible for product safety and labelling standards for consumer products including cosmetics.
- The Consumer Goods (Cosmetics) Information Standard 2020 which sets out the mandatory requirements applying to the labelling of all cosmetic products.
A therapeutic sunscreen is considered ‘exempt’ from the requirement to be included in the ARTG if:
- The SPF established according to the Australian Sunscreen Standard is less than 4.
- The label claims comply with the Australian Sunscreen Standard.
- The product does not have an indication for the treatment of a serious disease, condition, ailment or defect as specified in the most current Advertising Code.
- The product does not contain ingredients of human or animal origin [as listed in Item 8(g) of Schedule 5 of the Regulations]. Note: if the sunscreen contains one of these ingredients, it is not exempt from the requirement to be included in the ARTG.
Exempt therapeutic sunscreens do not need to be included in the ARTG, however, as these products are considered to be therapeutic goods, they must comply with all other relevant legislative requirements for therapeutic goods.
Sunscreens required to be included in the Australian Register of Therapeutic Goods (ARTG)
Therapeutic sunscreens requiring inclusion in the ARTG include:
- Primary sunscreens with a SPF of 4 or more.
- Secondary sunscreens that are not excluded from therapeutic goods legislation (under the Excluded Goods Determination) e.g. moisturising and after sun care products with an SPF of 15 or more.
The majority of therapeutic sunscreen products fall under the listed medicines framework and are included in the ARTG under section 26A of the Therapeutic Goods Act 1989 (the Act) and Item 7 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations). Sunscreen products can be listed medicines where they:
- only make therapeutic indications that are permitted for use in listed medicines
- only include ingredients that are permitted for use in listed medicines
- comply with the Australian Sunscreen Standard
Therapeutic sunscreens that are not exempt or not eligible to be listed in the ARTG require inclusion in the ARTG as registered therapeutic goods under section 25 of the Act. Products in this category include those that:
- contain an ingredient that is not a permitted ingredient in a listed medicine; and/or
- carry higher-level therapeutic indications that are not permitted for inclusion in listed medicines
As such, these products must be evaluated for suitability as either over-the-counter (OTC) registered medicines or prescription medicines. Further information can be found in the Australian Regulatory Guidelines for OTC Medicines (ARGOM) or the Australian Regulatory Guidelines for Prescription Medicines, respectively.
Combination sunscreen and insect repellent products
Therapeutic sunscreens that also make insect repellent claims must comply with all legislative requirements as for any other therapeutic sunscreen.
In addition, all insect repellents for human use must comply with any requirements of the Australian Pesticides and Veterinary Medicines Authority (APVMA). Refer to APVMA more information.