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About sunscreen regulation

3 December 2019

Primary sunscreens - regulated by the TGA

Primary sunscreens (products used primarily for protection from UV radiation, and with an SPF of 4 or more) are regulated as therapeutic goods by the TGA.

Secondary sunscreens - regulated by the TGA

Some secondary sunscreens (those with a primary purpose other than sun protection but also containing sunscreening agents) are regulated as therapeutic goods. These products include:

  • moisturisers containing sunscreen and an SPF greater than 15

Irrespective of SPF rating and status as a primary or secondary sunscreen, TGA also regulates:

  • all sunscreens (SPF 4 or more) that contain an insect repellant.
  • sunscreens with specific ingredients listed in Schedule 5 of the Therapeutic Goods Regulations 1990. These include those that are from humans, or particular organs from:
    • cows
    • sheep
    • goats
    • mule deer.

Secondary sunscreens - regulated by ACCC and NICNAS

Most secondary sunscreens (those with a primary purpose other than sun protection but also containing sunscreening agents) that are considered as 'cosmetic' products are excluded from TGA oversight under the Therapeutic Goods (Excluded Goods) Determination 2018. The manufacture and importation of cosmetic ingredients are regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), and product safety and cosmetic labelling standards are the responsibility of the Australian Competition and Consumer Commission (ACCS). These products include:

  • products intended for application to the lips with sunscreen if the SPF is 4 or higher
  • tinted bases and foundations with sunscreen if the SPF is 4 or higher
  • moisturising skin care products with sunscreen if the SPF is 15 or less
  • sunbathing skin care products with an SPF between 4 and 15