Australian regulatory guidelines for sunscreens (ARGS): Appendix 1: Labelling checklist

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22 January 2016

Appendix 1: Labelling checklist

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.

On this page: General | Labelling of immediate container and primary pack | Special requirements - small containers

General

General
Is/are the label (or labels):
printed on or firmly and securely attached to the container?
unlikely to become detached or defaced or illegible during use?
positioned so that it will not be damaged or removed when the container is opened?
not obscured by any other label or object?
printed in English?
printed in lettering that is clear, distinct and legible, and the height of letters with ascenders or descenders is not less than 1.5 mm (except for the AUST L number, which may be 1 mm high)?
As prohibited by the Therapeutic Goods Advertising Code section 4, is the labelling free from claims, statements or pictures that:
are likely to arouse unwarranted and unrealistic expectations of the product's effectiveness?
are false, unbalanced, unsubstantiated, misleading or likely to mislead the user?
abuse the trust or exploit the lack of knowledge of consumers or contain language that could bring about fear or distress?
encourage or are likely to encourage inappropriate use?
indicate or imply that the product is infallible, unfailing, magical, miraculous, or effective in all cases?
indicate or imply that the product cannot cause harm?
indicate or imply that other competitor products are harmful or ineffectual?
indicate or imply that the product is endorsed by any government agency, hospital or other facility providing healthcare services, individual healthcare professional or group of healthcare professionals?

Labelling of immediate container and primary pack

Labelling of immediate container and primary pack
Does the main label contain the following information:
the product name? Note: The use of the term 'sunblock' is not acceptable.
the name of the dose form, (for example, 'cream', 'lotion', 'stick')?
the sun protection factor (SPF) of the product preceded by the expression 'Sun Protection Factor' or 'SPF'? Note: A category description may also be given, for example, 'low/moderate or medium/high/very high protection'.
the fact that the product provides 'broad spectrum' protection from UV light (in letters no larger than the SPF)?
[if relevant] the water resistance of the product (in hours or minutes)? Note: 'sweat proof' and 'waterproof' are not acceptable claims.
the contents of the container (volume in mL or weight in g)?
the ARTG listing or registration number preceded by 'AUST L' or 'AUST R'? 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:
the names of all active ingredients expressed using Australian Approved Names AND the proportions of those ingredients either expressed as a percentage in terms of w/w or w/v or expressed as a weight in a stated weight or volume of the product using metric units of measurement (for example, mg/g or mg/mL)?
Is the following information included somewhere on the label(s) or container:
the batch or lot number of the product preceded by the batch number prefix using one of the formats specified in TGO 69 s2(1)?
the recommended storage conditions?
the expiry date preceded by the expiry date prefix using one of the formats specified in TGO 69 s2(1)?
if relevant, the presence in the product of benzoates, hydroxybenzoate ester(s), sulfites, or any other antimicrobial preservative(s), sorbates, ethanol (if >3% v/v), peanuts or peanut products (for example, peanut/arachis oil), or any other ingredient included in Schedule 1 of TGO 69?
required warning statements? 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):
a statement of the purpose or purposes of the product? Notes: The purpose of the product is generally made obvious by it being called a 'sunscreen'. 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. Any broad spectrum sunscreen may also carry a claim that it can aid in the prevention of premature skin ageing. Sunscreens may also carry justified non-therapeutic claims.
directions for use of the product? 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.
the name and address of the sponsor or Australian supplier of the product? 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):
Does the primary pack labelling include all of the information listed above?
Does the labelling on the container include at least the following information: 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.

Therapeutic Goods Administration (TGA)

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Australian regulatory guidelines for sunscreens (ARGS)

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Appendix 1: Labelling checklist

General

Labelling of immediate container and primary pack

Special requirements - small containers

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