We regulate sunscreens that are considered to be therapeutic goods (therapeutic sunscreens). Unless exempt, therapeutic sunscreens must be listed or registered in the Australian Register of Therapeutic Goods (ARTG) before they can legally supplied in Australia. Other sunscreens are exempt from therapeutic goods legislation and are not required to be in the ARTG e.g. cosmetic secondary sunscreens.
Types of sunscreens
We regulate therapeutic sunscreens. Therapeutic sunscreens include:
- primary sunscreens for UV radiation protection with SPF claims of 4 or more
- some secondary sunscreens.
The secondary sunscreens we regulate are products with a primary purpose other than sun protection that:
- that also contain sun screening agents, and
- that are not excluded from therapeutic goods legislation.
For example sunbathing and moisturising skin care products with an SPF of over 15.
Most therapeutic sunscreens fall under the listed medicines (‘lower risk’) framework and are listed in the ARTG. These products have an AUST L number on the label which is their ARTG identification number. Listed therapeutic sunscreens can be entered in the ARTG without a pre-market evaluation by us. This is based on the sponsor (product owner)’s assertion that the medicine meets all the applicable legislative requirements.
Therapeutic sunscreens are required to be registered in the ARTG if they:
- contain an ingredient that is not a permitted ingredient in a listed medicine, and/or
- carry higher-level therapeutic indications than those permitted for use in listed medicines.
Registered therapeutic sunscreens require pre-market evaluation of safety, quality and efficacy by us and will have an Aust R number on the label.
Many secondary sunscreen products are not considered to be therapeutic goods and are ‘excluded’ from therapeutic goods legislation under the Excluded Goods Determination. These are not therapeutic goods and do not need to be in the ARTG, for example: cosmetic skin foundations with SPF of 4 or more.
Sunscreens that must be entered in the ARTG
In Australia, unless exempt, therapeutic sunscreens must be listed or registered in the ARTG before they can legally be marketed in Australia. The person who applies for the ARTG entry is the medicine ‘sponsor’ and is legally responsible for the medicine.
Sunscreens must comply with the testing and labelling requirements included in the Australian Sunscreen Standard. This includes international standard (ISO) tests to determine:
- the SPF
- water resistance
- whether they are broad spectrum.
In addition to meeting the requirements of the Australian Sunscreen Standard, therapeutic sunscreens must comply with any relevant requirements in the Therapeutic Goods Act 1989. This includes requirements relating to labelling, advertising, manufacturing and reporting.
For more information
Visit Australian standards to read Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products - Evaluation and classification Read the Australian Regulatory Guidelines for Sunscreens.
Listed therapeutic sunscreens
Listed therapeutic sunscreens are considered lower risk than registered therapeutic sunscreens.
Listed therapeutic sunscreens are entered in the ARTG under section 26A of the Therapeutic Goods Act 1989 (the Act).Therapeutic sunscreens can be included in the ARTG as listed medicines if they:
- only make therapeutic claims related to sunscreen indications permitted for listed medicines
- only include ingredients permitted for use in listed medicines
- are made according to the principles of good manufacturing practice
- comply with all other applicable legislative requirements.
Permitted indications and ingredients for listed medicines are found in the Therapeutic Goods (Permissible Indications) Determination legislation.
Registered therapeutic sunscreens
Registered therapeutic sunscreens are entered in the ARTG under section 25 of the Act.
Therapeutic sunscreens require registration in the ARTG if they:
- contain an ingredient not permitted in a listed medicine
- have higher-level therapeutic indications not permitted in listed medicines.
Registered therapeutic products must be evaluated for safety, quality and efficacy as either over-the-counter (OTC) or prescription medicines.
- For more on registered OTC medicines, read our Australian Regulatory Guidelines for OTC Medicines.
- For more on prescription medicines, see the Australian Regulatory Guidelines for Prescription Medicines.
Combination sunscreen and insect repellent products
Therapeutic sunscreens making insect repellent claims must comply with all therapeutic sunscreen legislative requirements, as for any other sunscreens. In addition, all insect repellents for human use must comply with Australian Pesticides and Veterinary Medicines Authority requirements.
Not all sunscreens must be entered in the ARTG
We don’t regulate all sunscreens. Many secondary sunscreen products are not considered to be therapeutic goods. These secondary suncreens are ‘excluded’ from therapeutic goods legislation under the Therapeutic Goods (Excluded Goods) Determination 2018. These are not therapeutic goods and do not need to be in the ARTG, for example; cosmetic skin foundations with SPF of 4 or more.
Excluded sunscreens (cosmetic sunscreens)
Excluded sunscreens are products used, advertised or presented for supply in the following ways:
- Products with sunscreen intended for lip application if the 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 skincare products with sunscreen, including anti-wrinkle, anti-ageing and skin whitening products
- in a pack not larger than 300 mL or 300 g
- if the SPF is between 4 and 15.
- Sunbathing skincare products such as oils, creams, gels, tanning products without sunscreen, and after-sun care products
- in a pack not larger than 300 mL or 300 g
- with an SPF between 4 and 15.
Other regulations do apply to these products. For more information, visit the relevant regulator website:
- 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.
Some therapeutic sunscreens are ‘exempt’ from the requirement to be included in the ARTG under item 8(g) Schedule 5 of the Regulations. While 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 the requirement to be entered in the ARTG if:
- the SPF is less than 4
- the label claims comply with the Australian Sunscreen Standard
- it does not have an indication for treating a serious disease, condition, ailment or defect as specified in the Advertising Code
- it does not contain ingredients of human or animal origin, as listed in Item 8(g) of Schedule 5 of the Regulations.