The TGA is aware of reporting by the ABC in late 2025 - external site about companies allegedly using the same Australian Register of Therapeutic Goods (ARTG) listing number (called an AUST number) for multiple sunscreen products that have different names and/or different intended uses (called indications) from those recorded in the ARTG.
The purpose of this statement is to provide guidance to industry about how the Therapeutic Goods Act 1989 (Act) applies in relation to sunscreen labelling.
The TGA expects that, because of this issue, some sunscreens may be withdrawn from supply in Australia. The TGA also acknowledges that some consumers may currently be using an affected sunscreen. This statement is therefore also intended to give information to the public about the reasons those sunscreens are being withdrawn from supply and what consumers should do if they are using one of the affected sunscreens.
Information for industry
Summary
The name and indications on the label of a sunscreen must match the name and indications listed in the ARTG for the AUST number on the label.
If the name and indications on the sunscreen are different from the ARTG, then the sunscreen is not listed in the ARTG, even if it has an AUST number on the label.
If you are manufacturing, advertising or supplying a sunscreen that is not listed in the ARTG, you may be committing a criminal offence and you may be liable for civil penalties.
The therapeutic goods framework
Sunscreens that are represented as being primarily to protect the skin from ultraviolet (UV) radiation must be in the ARTG unless they are exempt. Sunscreens can be included in the ARTG in two ways:
- Sunscreens that are for application to the skin and meet the criteria in item 7 of Schedule 4 to the Therapeutic Goods Regulations 1990 (Regulations) are 'listable goods'. This means that they can be 'listed' in the ARTG.
- Sunscreens that are not for application to the skin or do not meet the criteria in item 7 of Schedule 4 to the Regulations must be 'registered' in the ARTG. This is a much higher regulatory threshold and is usually used for higher risk therapeutic goods.
The therapeutic goods framework is designed to make sure that things that are in the ARTG are the same as the goods that are being manufactured, advertised and supplied in the Australian market.
For 'listable goods' other than export only medicines, this means that the goods being manufactured, advertised and supplied must have the same name and indications as the goods listed in the ARTG (see s 16(1A)(d) of the Act when read with r 11(1)(a) and (b) of the Regulations). If the goods being manufactured, advertised and supplied do not have the same name and indications as the goods listed in the ARTG, they are 'separate and distinct' from the goods listed in the ARTG. This has the legal effect that the goods, as manufactured, advertised and/or supplied, are not in the ARTG at all.
A person is the sponsor of a sunscreen if they export, import or manufacture the sunscreen, or arrange for that to be done, unless they do so on behalf of another person who resides, or carries on a business, in Australia.
If you are the sponsor of a sunscreen affected by the issues described above, it is unlawful for you to manufacture (including by labelling), supply or advertise the sunscreen unless an exemption, approval or authority applies.
If you are not the sponsor, it is unlawful for you to advertise the sunscreen and it is unlawful for you to supply the sunscreen to anyone other than the ultimate consumer.
The TGA's concerns
The TGA has identified cases where sunscreens have been labelled with an AUST number but the name or indications on the label of the goods do not match the information in the ARTG for that AUST number.
The laws dealing with these issues are important. They ensure that consumers and businesses can properly identify the entry in the ARTG associated with a sunscreen if needed, and they help to facilitate adverse event reporting and post-market actions such as recalls. They also help the TGA ensure that businesses have evidence that their sunscreens work.
What to do if I identify this problem with my product?
If you think that you are unlawfully dealing with a sunscreen that is not listed in the ARTG for the reasons set out above, you should immediately stop what you are doing.
If you want to continue dealing with that sunscreen, you must make sure that the sunscreen is entered in the ARTG with the correct details. This means that the sponsor of the sunscreen must:
- Apply for a new ARTG listing for the sunscreen with its actual name and indications.
- Make the required certifications under section 26A of the Act, including that you hold evidence to support each indication for the sunscreen.
- Ensure all labelling and presentation is accurate and complies with Therapeutic Goods Orders and applicable regulatory requirements.
- Ensure that any labelling activities are conducted by a TGA‑licensed or TGA‑certified GMP facility, as labelling of finished goods is considered a manufacturing step.
If you are unsure whether you are unlawfully manufacturing, advertising or supplying sunscreen for the reasons set out above, you should consider seeking independent advice from a regulatory affairs consultant or lawyer.
What will the TGA do?
The TGA will continue reviewing the manufacture, advertising and supply of white‑labelled sunscreens and sunscreens with customised labels to assess whether compliance or enforcement action is warranted.
