Sunscreen regulation in Australia

We regulate sunscreens that are therapeutic goods (therapeutic sunscreens).

Generally, therapeutic sunscreens must be in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied or sold in Australia.

Other sunscreens are excluded from therapeutic goods legislation and are not required to be in the ARTG for example, cosmetic secondary sunscreens.

Therapeutic sunscreens we regulate

Therapeutic sunscreens include:

• Primary sunscreens: products that are represented as being used primarily to protect the skin from ultraviolet (UV) radiation.
• some secondary sunscreen products: products that are represented as having a primary function other than sun protection whilst still providing some protection of the skin from UV radiation, but are not excluded from therapeutic goods legislation. For example, sunbathing and moisturising skin care products with an SPF of over 15.

Including a therapeutic sunscreen in the ARTG

Therapeutic sunscreens are generally regulated under the listed medicines framework and have an AUST L number on the label. See listed medicines for more details on the framework.

Applications to include therapeutic sunscreens in the ARTG are done electronically online using the TGA Business Services portal.

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.

Fees and charges are associated with including a product in the ARTG.

If you are a sponsor who has no previous experience with listing a therapeutic good in Australia, you may wish to seek the services of an Australian regulatory affairs consultant.

Requirements for therapeutic sunscreens supplied in Australia

The sponsor (product owner) of a listed therapeutic sunscreen must ensure that their product meets all legislative requirements including that the product:

• only includes permitted sunscreen ingredients
• only uses permitted sunscreen indications (claims)
• is manufactured by a TGA approved manufacturing facility
• meets the testing and labelling requirements provided in Australian standard for sunscreens adopted by the TGA
• meets all other therapeutic good legislative requirements, such as labelling and advertising.

For more information on regulatory requirements for therapeutic sunscreens refer to Understanding the regulation of therapeutic sunscreens (previously the Australian regulatory guidelines for sunscreens).

Sunscreen products we do not regulate

We don’t regulate all sunscreens. Many secondary sunscreen products are not therapeutic goods. Excluded sunscreens do not need to be included in the ARTG.

Excluded sunscreens (e.g. cosmetic sunscreens)

Secondary sunscreens are excluded from therapeutic goods legislation under the Therapeutic Goods (Excluded Goods) Determination 2018.

Excluded sunscreens are secondary sunscreen products

• products for application to the lips with SPF 4 or more.
• tinted bases and foundations (liquids, pastes or powders) with SPF 4 or more.
• moisturising skincare products for dermal application (including anti-wrinkle, anti-ageing and skin whitening products):
  • in a pack not larger than 300ml or 300g
  • with an SPF between 4 and 15
  • not presented as being water resistant
  • not presented as making therapeutic claims like claims about skin cancer.
• sunbathing skincare products (oils, creams, gels, tanning products without sunscreen, and after-sun care products)
  • in a pack not larger than 300ml or 300g
  • with an SPF between 4 and 15
  • not presented as being water resistant
  • not presented as making therapeutic claims like claims about skin cancer.

• The Australian Industrial Chemicals Introduction Scheme regulates the manufacture and import of industrial chemicals including ingredients used in cosmetic sunscreens.
• The Australian Competition and Consumer Commission is responsible for product safety and labelling standards for consumer products including cosmetics.
• The Consumer Goods (Cosmetics) Information Standard 2020 sets out the mandatory requirements applying to the labelling of all cosmetic products.