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Australian regulatory guidelines for sunscreens (ARGS)

Version 1.2

30 August 2019

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2. Therapeutic sunscreen or cosmetic sunscreen?

This guideline is currently under review.

2.1 Therapeutic sunscreens

For the purpose of these Guidelines, sunscreens that are regulated as therapeutic goods under the Act and the Regulations and are not classified and regulated as cosmetics (see subsection 2.2) are referred to as 'therapeutic sunscreens'. Included in this category are:

  • primary sunscreens with SPF 4 or more
  • secondary sunscreens - except those regulated as cosmetics (see subsection 2.2)
  • primary or secondary sunscreens with SPF 4 or more that contain an insect repellent
  • sunscreens that are exempt from being listed under the Act because they come within the exemption in Item 8(g) of Schedule 5 of the Regulations.

2.2 Cosmetic sunscreens

Some products contain an ingredient with sunscreening properties but the primary purpose of the product is neither sunscreening nor therapeutic. These products are regulated as cosmetics by the National Industrial Chemicals Notification & Assessment Scheme (NICNAS) rather than by the TGA as therapeutic goods. In accordance with the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011, these products are not regulated under the Therapeutic Goods legislation and are not required to be included in the ARTG. For the purpose of these Guidelines such products are called 'cosmetic sunscreens'. They may also be referred to as 'excluded' sunscreens.

A cosmetic sunscreen product must meet the definition of a cosmetic under the Industrial Chemicals (Notification and Assessment) Act 1989 and any requirements set out in the current Cosmetics Standard and NICNAS Cosmetics Guidelines. Requests for regulatory information and enquiries about cosmetic products should be directed to NICNAS.

Section 5 of the Industrial Chemicals (Notification and Assessment) Act 1989 defines a cosmetic as follows:

  • 'Cosmetic means:
    1. substance or preparation intended for placement in contact with any external part of the human body, including:
      1. the mucous membranes of the oral cavity; and
      2. the teeth;
        with a view to:
      3. altering the odours of the body; or
      4. changing its appearance; or
      5. cleansing it; or
      6. maintaining it in good condition; or
      7. perfuming it; or
      8. protecting it; or
    2. substance or preparation prescribed by regulations made for the purposes of this paragraph; but does not include:
    3. therapeutic good within the meaning of the Therapeutic Goods Act 1989; or
    4. a substance or preparation prescribed by regulations made for the purposes of this paragraph.'

The current Cosmetics Standard and the associated NICNAS Cosmetics Guidelines should be consulted for guidance on the conditions applying to the following secondary sunscreen products for them to be regulated as cosmetics rather than therapeutic goods:

  1. Make-up products for the face and nails:
    • tinted bases or foundation (liquids, pastes or powders) with sunscreen
    • products (tinted or untinted) intended for application to the lips with sunscreen.
  2. Skin care products:
    • some moisturising products with sunscreen for dermal application, including anti-wrinkle, anti-ageing and skin whitening products
    • some sunbathing products (for example, oils, creams or gels, including products for tanning without sun and after sun care products).

The Cosmetics Standard and NICNAS Cosmetics Guidelines include specific requirements regarding the presentation and labelling of cosmetic sunscreen products. Sponsors are responsible for ensuring that such products comply with those requirements. Failure to comply with those requirements may make the product concerned a therapeutic good that must be listed or registered in the ARTG.

Other mandatory requirements applying to the labelling of all cosmetic products are set out in Cosmetic & toiletries ingredient labelling published by the Australian Competition & Consumer Commission (ACCC).

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