Sunscreen regulation in Australia

The TGA is currently in the process of removing the exemption provisions in the Regulations for sunscreens with less than SPF 4.

We regulate sunscreens that are considered to be therapeutic goods (therapeutic sunscreens).

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

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

Therapeutic sunscreens we regulate

We regulate therapeutic sunscreens, these 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, that contain sun screening agents but are not excluded from therapeutic goods legislation for example, sunbathing and moisturising skin care products with an SPF of over 15.

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

Other therapeutic sunscreens are regulated as registered medicines. These products have AUST R on the label. See Non-prescription medicines for more details on the registered framework.

Registered therapeutic sunscreens:

• contain an ingredient that is not a permitted ingredient in a listed sunscreen
• carry higher-level therapeutic indications than those permitted for use in listed sunscreens.

Supplying a sunscreen product in Australia

To supply a sunscreen product in Australia, a sponsor (“product owner”) must apply to enter it in the Australian Register of Therapeutic Goods (ARTG).

To do that you must ensure your therapeutic sunscreen complies with our legislation and meets strict standards. For more information on regulatory requirements for therapeutic sunscreens refer to the Australian regulatory guidelines for sunscreens (ARGS).

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

Fees and charges are associated with including a product on the ARTG and for obtaining a Good Manufacturing (GMP) licence. See Manufacturing requirements and standards for non-prescription medicines for more information about GMP.

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.

Sunscreen products we do not regulate

We don’t regulate all sunscreens. Many secondary sunscreen products are not considered to be therapeutic goods. Exempt or excluded sunscreens do not need to be included on the ARTG.

Excluded sunscreens (cosmetic sunscreens)

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

Excluded sunscreens are products used, advertised or presented for supply in the following ways:

• 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.
• 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.

Other regulations do apply to these products. For more information, visit the relevant regulator website:

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

Exempt sunscreens

Some therapeutic sunscreens are ‘exempt’ from being included in the ARTG. While they are not required to be in the ARTG, they are still therapeutic goods and must comply with all other therapeutic goods legislative requirements.

A therapeutic sunscreen is exempt from being on 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 treating a serious disease, condition, ailment or defect as specified in the 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.