Australian regulatory guidelines for sunscreens (ARGS)

This guidance is being revised to include information on calculating safe concentrations of new sunscreen ingredients using the Australian Sunscreen Exposure Model (ASEM). In addition, the name of this guidance will be updated to Understanding the Regulation of Therapeutic Sunscreens (URTS).

The ASEM will now be used for assessing new ingredients that can absorb through the skin. For more details, see the ASEM public consultation paper or email us to arrange a pre-submission meeting.

Purpose

The Australian Regulatory Guidelines for Sunscreens (ARGS) describe the regulatory requirements and standards for sunscreens (and their ingredients) regulated as therapeutic goods in Australia by the TGA under the Therapeutic Goods Act 1989.

For the purpose of the ARGS, sunscreens that are regulated as therapeutic goods are referred to as 'therapeutic sunscreens'. Therapeutic sunscreens include:

• Primary sunscreens: Products that are used primarily for protection from UV radiation.
• Some secondary sunscreens: Products with a primary purpose other than sun protection, but also contain sunscreening agents and are not excluded from the therapeutic goods legislation.

Many secondary sunscreen products, such as cosmetic sunscreens, are not considered to be therapeutic goods and are 'excluded' from therapeutic goods legislation.

For more information

• Email: nonprescriptionmedicines@health.gov.au
• Phone: 1800 020 653 (free call within Australia).