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Australian regulatory guidelines for sunscreens (ARGS)

Version 1.2

30 August 2019

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Appendix 1: Labelling checklist

This guideline is currently under review.

Note: This check list is not mandatory. It is designed to assist sponsors in designing their labels for therapeutic sunscreens in accordance with the TGA's requirements. It is not exhaustive. Sponsors are reminded that they are responsible for ensuring that their labelling complies with all of the relevant legislative requirements. These labelling requirements do not apply to those secondary sunscreen products categorised as cosmetics.

General

General
Is/are the label (or labels):
As prohibited by the Therapeutic Goods Advertising Code section 4, is the labelling free from claims, statements or pictures that:

Labelling of immediate container and primary pack

Labelling of immediate container and primary pack
Does the main label contain the following information:
  • Note: The use of the term 'sunblock' is not acceptable.
  • Note: A category description may also be given, for example, 'low/moderate or medium/high/very high protection'.
  • Note: 'sweat proof' and 'waterproof' are not acceptable claims.
  • Note: If the container is packed in an outer carton the listing number must be on the main label of that carton and may also be but is not required to be on the container.
Is the following information included either on the main label or on a rear or side panel:
Is the following information included somewhere on the label(s) or container:
  • Note: The label for a primary sunscreen should include warning statements to the effect that: prolonged exposure to the sun should be avoided, it is important to wear protective clothing, hats and eyewear when exposed to the sun, and the product should be kept out of the eyes.
Is the following information included somewhere on the label(s):
  • Notes:
    1. The purpose of the product is generally made obvious by it being called a 'sunscreen'.
    2. If a sunscreen has an SPF of 30 or higher and it provides broad spectrum protection the label is permitted to include claims that the product may assist in preventing some skin cancers or may reduce the risk of some skin cancers provided the label also highlights the need for avoidance of prolonged exposure to the sun and the importance of wearing protective clothing, hats and eyewear.
    3. Any broad spectrum sunscreen may also carry a claim that it can aid in the prevention of premature skin ageing.
    4. Sunscreens may also carry justified non-therapeutic claims.
  • Note: The directions for use for a primary sunscreen should include statements to the effect that the product should be applied in generous amounts over all of the exposed areas 15 to 20 minutes before sun exposure, and again after swimming or towelling. An indication should also be given of how frequently the product should be re-applied during prolonged exposure to the sun.
  • Note: An Australian contact telephone number may also be included.

Special requirements - small containers

Special requirements - small containers
If the immediate container has a capacity of 20mL or less AND the container is enclosed in a primary pack (for example, carton):
    • the product name (in full or in abbreviated form if there is insufficient room for the full name)?
    • the name of the dosage form?
    • the quantity of product in the container?
    • the batch number preceded by the batch number prefix?
    • the names and quantities of all the active ingredients?
    • Note: If there is insufficient room, the information regarding active ingredients is only required on the label of the primary pack.

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