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Sunscreen standard 2012: information for retailers

13 November 2012

The TGA has made changes to how new sunscreen products are authorised for supply in Australia. This is in response to Standards Australia and Standards New Zealand updating the Australian/New Zealand Standard 2604 Sunscreen products - Evaluation and classification from AS/NZS 2604:1998 to AS/NZS 2604:2012.

  • Sunscreens already supplied, which meet the 1998 Standard, can still be sold and are allowed to be labelled with a rating of up to SPF 30+.
  • New sunscreens listed on the Australian Register of Therapeutic Goods (ARTG) from 10 November 2012 will need to meet the 2012 Standard, which incorporates  labelling with a rating of up to SPF 50+ and sets stringent requirements for the broad spectrum performance.

The questions and answers below provide information on the changes for people selling sunscreens.

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Please refer your customers to the TGA information: Sunscreens: information for consumers.

  • The SPF 50+ sunscreens contain the same ingredients as those already used in SPF 30+ sunscreens.
  • While broad spectrum SPF 50+ sunscreens provide better protection against both UVA and UVB radiation, you still need to be SunSmart with SPF 50+ sunscreens, and apply liberally every two hours.
  • Customers should select a sunscreen that is appropriate to their skin sensitivity and exposure to the sun. A water-resistant sunscreen should be used if sweating heavily or participating in swimming or water sports.
  • SPF 30+ sunscreens remain a valid and useful sun protection. SPF 30+ sunscreens will still be available in the shops.

The TGA will be accepting notifications from sunscreen suppliers and manufacturers from 10 November 2012. This process is electronic, so an AUST L number will be issued electronically by the TGA as soon as the notifier has provided all the required information.

The TGA has been informed that some companies are ready to make notifications as soon as this is permitted. After 10 November 2012, retailers will be able to sell SPF 50+ sunscreens that have been given an AUST L number.

Yes. Existing sunscreens (most have SPF 30+) that were listed on the ARTG prior to 10 November 2012 remain legal to supply in Australia. These products remain safe and effective for use while they are within the labelled expiry date. There is no safety reason for the stock to be removed from the shelf or returned to the manufacturer.

There is no legislated end-date when the sale of SPF 30+ sunscreens will stop being legal. Retailers are free to continue selling SPF 30+ products for as long as they wish.