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Understanding the regulation of therapeutic sunscreens

This guidance explains how sunscreens are regulated in Australia and the requirements for sunscreens (and their ingredients) regulated by us.

(This guidance was previously known as Australian Regulatory Guidelines for Sunscreens).

Published
Last updated

This guidance has been 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 has been 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.

Purpose

The TGA regulates sunscreens in Australia that are classified as therapeutic goods to make sure they are safe, efficacious and high quality.

Understanding the regulation of therapeutic sunscreens (‘this guidance’) explains which sunscreens are regulated by the TGA (therapeutic sunscreens) and which, providing they meet certain requirements, are not regulated by the TGA (e.g. cosmetic sunscreens).

This guidance also provides:

  • information on the Australian regulatory requirements for therapeutic sunscreens
  • requirements for new sunscreen ingredients
  • guidance on how to change an entry in the Australian Register of Therapeutic Goods (ARTG) for a listed sunscreen.

Many of the terms referred to in this guidance, such as ‘therapeutic sunscreen’, ‘cosmetic’, ‘primary sunscreen’, ‘secondary sunscreen’, and ‘sun protection factor’ (SPF) are defined in Glossary of terms and abbreviations.

For more information

Legislation

Guidance

This Guidance is presented as downloadable files because of its length. 

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Page history

Show all page updates (7)
  • Removed the specific number of years for market exclusivity and reference the Understanding the application requirements for a new substance in listed medicines.
  • Document name changes:
    • Australian Regulatory Guidelines for Sunscreens to Understanding the regulation of therapeutic sunscreens.
    • Application requirements for new substances in listed medicines to Understanding the application requirements for a new substance in listed medicines.
  • Included information on how requesting for pre-submission meetings prior to lodging an application for registered therapeutic sunscreens.
  • Included information about how to determine the safe concentration of substances that may be absorbed using the Australian Sunscreen Exposure Model, including further information in Appendix 2.
  • Update to section Safety data requirements for new ingredients for use in listed therapeutic sunscreens:
    • Added additional information that should be considered for safety assessment including importance of clearly stating concentration sought and consideration of both short- and long-term effects.
    • Added clarification that justifications may be acceptable in lieu of some core information categories.
  • Removed references to exempt sunscreens.
  • Updated reference to the Australian Sunscreen Standard to AS/NZS standard for sunscreens.
  • Updated Table 9 to include methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate, which is a new ingredient listed in the Permissible Ingredients Determination.
  • Minor formatting changes including table titles.
  • Updated to a new template.
  • Major change to the sections:
    • Ingredients permitted for use in listed therapeutic sunscreen and Applying for a new ingredient to be used in listed therapeutic sunscreens
      • updated links to reference to updated guidance documents ‘Application requirements for new substances in listed medicines’ and ‘Guidance on using Comparable Overseas Body reports’.
      • included option for eligible new ingredients to receive a 2-year exclusivity period.
      • updated quality and safety data requirements to refer to ‘Application requirements for new substances in listed medicines’ to align the data requirements for all listed medicines ingredients.
      • added Tables 3 and 4 to specify respective quality and safety core information requirements for a new ingredient to be used in listed therapeutic sunscreens. Rearranged and updated information for consistency.
      • included the provision of using the COBs-based process.
    • SPF test results for listed therapeutic sunscreens:
      • Removed details of SPF testing and updated to follow the ISO testing methods.
  • Editorial and minor changes to overall text to remove repetitive information.
  • Updated links to current documents.
  • Images in Appendix 2 replaced with higher resolution examples.
  • New terms added to the ‘Glossary of terms and abbreviations’.
  • Updates to Table 7: List of active sunscreen ingredients
    • Removed aminobenzoic acid (PABA) to align with removal of ingredient from the Permissible Ingredients Determination.
    • Amended a typographical error for the maximum level of use for PEG-25 PABA to 10%.
  • Restructured into Parts A and Part B.
  • Removed Australian Sunscreen Standard specific reference and outdated information.
  • New table with Sunscreen SPF categories. Clarification of sunscreen regulatory categories. New information on indications permitted for use in listed medicines.
  • New subsection on adverse reactions.
  • Removed Bibliography and instead provided hyperlinks in document.
  • Updated Glossary.
  • New information on EMA guidelines.
  • Changed NICNAS to AICIS.
  • New subsection on alternative test methods.
  • Removed reference to RASML.
  • New information on searching the ingredient database.
  • Reinstated the table of active ingredients.
  • Updated links to legislation and guidelines: e.g. Therapeutic Goods Orders; Advertising Code; Excluded Goods Determination, ELF user guide.
  • Removed reference to the Cosmetics Standards and the NICNAS Cosmetic Guidelines.
  • Included links to the Industrial Chemicals Act 2019 and the Consumer Goods (Cosmetics) Information Standard 2020.
  • Updated to remove Table 3 – Permitted active ingredients for therapeutic sunscreens and replace with links to the Therapeutic Goods (Permissible Ingredients) Determination.
  • Updated to reflect the changes to the Therapeutic Goods Regulations 1990 by removing references to sunscreens with a claimed SPF of <4 that contain certain human or animal derived ingredients.
  • Updated the relevant sections by including reference to the recently made Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015.
  • Updated the table listing the permitted active ingredients by adding the newly approved sunscreen active Tris-biphenyl triazine.

Original publication.

  • Removed the specific number of years for market exclusivity and reference the Understanding the application requirements for a new substance in listed medicines.
  • Document name changes:
    • Australian Regulatory Guidelines for Sunscreens to Understanding the regulation of therapeutic sunscreens.
    • Application requirements for new substances in listed medicines to Understanding the application requirements for a new substance in listed medicines.
  • Included information on how requesting for pre-submission meetings prior to lodging an application for registered therapeutic sunscreens.
  • Included information about how to determine the safe concentration of substances that may be absorbed using the Australian Sunscreen Exposure Model, including further information in Appendix 2.
  • Update to section Safety data requirements for new ingredients for use in listed therapeutic sunscreens:
    • Added additional information that should be considered for safety assessment including importance of clearly stating concentration sought and consideration of both short- and long-term effects.
    • Added clarification that justifications may be acceptable in lieu of some core information categories.
  • Removed references to exempt sunscreens.
  • Updated reference to the Australian Sunscreen Standard to AS/NZS standard for sunscreens.
  • Updated Table 9 to include methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate, which is a new ingredient listed in the Permissible Ingredients Determination.
  • Minor formatting changes including table titles.
  • Updated to a new template.
  • Major change to the sections:
    • Ingredients permitted for use in listed therapeutic sunscreen and Applying for a new ingredient to be used in listed therapeutic sunscreens
      • updated links to reference to updated guidance documents ‘Application requirements for new substances in listed medicines’ and ‘Guidance on using Comparable Overseas Body reports’.
      • included option for eligible new ingredients to receive a 2-year exclusivity period.
      • updated quality and safety data requirements to refer to ‘Application requirements for new substances in listed medicines’ to align the data requirements for all listed medicines ingredients.
      • added Tables 3 and 4 to specify respective quality and safety core information requirements for a new ingredient to be used in listed therapeutic sunscreens. Rearranged and updated information for consistency.
      • included the provision of using the COBs-based process.
    • SPF test results for listed therapeutic sunscreens:
      • Removed details of SPF testing and updated to follow the ISO testing methods.
  • Editorial and minor changes to overall text to remove repetitive information.
  • Updated links to current documents.
  • Images in Appendix 2 replaced with higher resolution examples.
  • New terms added to the ‘Glossary of terms and abbreviations’.
  • Updates to Table 7: List of active sunscreen ingredients
    • Removed aminobenzoic acid (PABA) to align with removal of ingredient from the Permissible Ingredients Determination.
    • Amended a typographical error for the maximum level of use for PEG-25 PABA to 10%.
  • Restructured into Parts A and Part B.
  • Removed Australian Sunscreen Standard specific reference and outdated information.
  • New table with Sunscreen SPF categories. Clarification of sunscreen regulatory categories. New information on indications permitted for use in listed medicines.
  • New subsection on adverse reactions.
  • Removed Bibliography and instead provided hyperlinks in document.
  • Updated Glossary.
  • New information on EMA guidelines.
  • Changed NICNAS to AICIS.
  • New subsection on alternative test methods.
  • Removed reference to RASML.
  • New information on searching the ingredient database.
  • Reinstated the table of active ingredients.
  • Updated links to legislation and guidelines: e.g. Therapeutic Goods Orders; Advertising Code; Excluded Goods Determination, ELF user guide.
  • Removed reference to the Cosmetics Standards and the NICNAS Cosmetic Guidelines.
  • Included links to the Industrial Chemicals Act 2019 and the Consumer Goods (Cosmetics) Information Standard 2020.
  • Updated to remove Table 3 – Permitted active ingredients for therapeutic sunscreens and replace with links to the Therapeutic Goods (Permissible Ingredients) Determination.
  • Updated to reflect the changes to the Therapeutic Goods Regulations 1990 by removing references to sunscreens with a claimed SPF of <4 that contain certain human or animal derived ingredients.
  • Updated the relevant sections by including reference to the recently made Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015.
  • Updated the table listing the permitted active ingredients by adding the newly approved sunscreen active Tris-biphenyl triazine.

Original publication.