Australian regulatory guidelines for sunscreens (ARGS)
4. Labelling and advertising
The labelling and advertising of therapeutic sunscreen products included in the ARTG must comply with the relevant requirements of each of the following:
- the Labelling Order, Therapeutic Goods Order No 69 (or any subsequent order amending or replacing TGO 69)
- the Therapeutic Goods Advertising Code (as updated from time to time)
- the Australian/New Zealand Standard AS/NZS 2604:2012 Sunscreen products - Evaluation and classification
- the current edition of Required Advisory Statements for Medicine Labels (RASML).
A check list is provided at the end of this document (Appendix 1) to assist sponsors in designing their sunscreen labels in accordance with the requirements of the documents listed above. However, the check list is not exhaustive and sponsors are responsible for ensuring that their labelling complies with all of the relevant legislative requirements.
TGO 69, the Therapeutic Goods Advertising Code and the RASML do not apply to cosmetic sunscreens.
As required by sections 2 and 3 of the Labelling Order (TGO 69), the label (or labels) must:
- be printed on or firmly and securely attached to the container
- be unlikely to become detached or defaced or illegible during use
- be positioned so that it will not be damaged or removed when the container is opened
- not be obscured by any other label or object
- be printed in English
- be 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 or AUST R number, which may be 1 mm high).
As prohibited by section 4 of the Therapeutic Goods Advertising Code, the labelling must be 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.
Therapeutic sunscreens that are 'listable' are permitted to carry the following coded indications provided that the sunscreen meets the requirements of AS/NZS 2604:2012 for the indications designated:
- A broad spectrum sunscreen with an SPF of 30 or higher is permitted to carry the following indications:
- 'May assist in preventing some skin cancers.'
- 'May reduce the risk of some skin cancers.'
- 'Can aid in the prevention of solar keratoses.'
- 'Can aid in the prevention of sunspots.'
- A broad spectrum sunscreen with an SPF of 4 or higher is permitted to carry the following indication:
- 'Can aid in the prevention of premature skin ageing.'
In principle, indications considered appropriate for listed sunscreens are those that can be used safely and effectively without the intervention of a healthcare practitioner. For medicines generally this includes diseases, disorders or conditions that are normally of a benign or self-limiting nature that the average consumer can be expected to evaluate or diagnose accurately. Some indications that relate to a serious disease condition, ailment or defect such as skin cancer are restricted except those allowed above which have been approved by the TGA for therapeutic sunscreens.
The Act requires that, at the time of listing a medicine in the ARTG, a sponsor must certify that it holds the information or evidence to support indications and claims made in relation to the product. All indications and claims must be capable of substantiation - that is, evidence held by the sponsor must adequately demonstrate all indications and claims made for the product are true, valid and not misleading.
Listed medicines are not subject to pre-market evaluation for efficacy at the time of listing. However, data supporting the indications may be requested by the TGA for review after listing of a medicine. Hence, the TGA may request copies of labelling and the results of pre-market SPF, broad spectrum performance, water resistance or stability testing. If requested, it is expected that this information will be available and can be provided to the TGA within a reasonable time of the request.
Therapeutic sunscreens may also carry justified non-therapeutic claims (for example, 'contains Vitamin E', 'contains aloe vera', 'moisturising', 'antioxidant', 'free radical barrier') and information to support such claims may be requested by the TGA for review. If the certification by the sponsor that it holds this information or evidence is incorrect, the TGA can cancel the listing of the product from the ARTG.
The labelling may also carry company logos, other symbols and consumer information provided these do not create confusion for Australian consumers and they do not conflict with the requirements of the Therapeutic Goods legislation, the Labelling Order, the Sunscreen Standard or the Advertising Code.
If the formulation includes a proprietary ingredient, the sponsor should check with the manufacturer or supplier of the proprietary ingredient to ascertain that it does not contain any specified excipients that must be declared on the labels in accordance with TGO 69.
4.2 Labelling of immediate container and primary pack
As required by subsection 3(2) of the Labelling Order and section 7 of the Sunscreen Standard AS/NZS 2604:2012, the main label on the container and the main label of the primary pack (for example, carton), if any, must ontain all of the following information:
- the product name
- Note: The use of the term 'sunblock' is not acceptable as part of a product name (or elsewhere on the label). The term is a misnomer because sunscreens filter to varying degrees but do not completely block the sunburning radiation.
- the name of the dose form, for example, 'cream' or 'lotion'
- the sun protection factor (SPF) of the product preceded by the expression 'Sun Protection Factor' or 'SPF' marked in durable and legible characters and in such colour or colours as to afford a distinct contrast to the background colour and in letters not less than 1.5mm in height
- Note: A category description may also be given, for example, 'low / medium or moderate / high / very high protection'.
- [if relevant] the water resistance of the product (in hours or in minutes) established in accordance with AS/NZS 2604:2012
- Note: The use of the terms 'waterproof' and 'sweat proof' are not acceptable. Sunscreens may be water resistant but none are completely waterproof, and even those with a high water resistance rating will gradually wash off the skin when immersed in water for long enough or through perspiration.
- the statement 'broad spectrum' in letters not larger than those used for the SPF provided that the product meets the criteria of broad spectrum protection from UV (or UVA and UVB) light as defined and measured by AS/NZS 2604:2012
- the net quantity of the goods (by volume in mL or weight in g)
- the ARTG listing number preceded by 'AUST L' or registration number preceded by 'AUST R'.
- Note: If the container is packed in an outer carton the listing or registration number must be on the main label of that carton and may be, but is not required to be, on the container as well.
All of the following information must be included either on the main label or on a rear or side panel [see subsection 3(3)(c) of the Labelling Order]:
- the names of all sunscreening active ingredients expressed using Australian Approved Names (AAN)
- Note: International Nomenclature of Cosmetic Ingredients (INCI) names may also be included in addition to (but not as a substitute for) the AANs.
- 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).
All of the following information must be included somewhere on the label(s) or container:
- the recommended storage conditions 'store below 25°C' or 'store below 30°C', as applicable
- the batch or lot number of the product, preceded by the batch number prefix using one of the formats specified in subsection 2(1) of the Labelling Order
- the expiry date of the product preceded by the expiry date prefix 'Expiry Date', 'EXPIRY DATE', 'Expiry', 'EXPIRY', 'Expires', 'EXPIRES', 'Exp. Date', 'EXP. DATE', 'Use before', 'USE BEFORE', 'Use By', 'USE BY', 'Exp', or 'EXP'
- Note: Terms such as 'Best by' or words to this effect are not acceptable.
- if relevant, the presence in the product (preceded by the word 'contains') of any ingredient listed in the First Schedule to the Labelling Order, including:
- benzoic acid, calcium benzoate, potassium benzoate or sodium benzoate
- Note: If the product contains more than one of these substances, they may be grouped under the term 'benzoates'.
- ethanol (if > 3% v/v)
- hydroxybenzoate ester(s) (for example, ethyl, methyl, propyl, sodium ethyl, sodium methyl, sodium propyl hydroxybenzoate)
- Note: If the product contains more than one of these substances, they may be grouped under the term 'hydroxybenzoates'.
- peanuts and peanut products (for example, peanut oil, arachis oil)
- sorbic acid or potassium sorbate
- Note: If the product contains more than one of these substances, they may be grouped under the term 'sorbates'.
- sulfite, metabisulfite and bisulfite salts and sulfur dioxide
- Note: If the product contains more than one of these substances, they may be grouped under the term 'sulfites'.
- tartrazine or 'tartrazine CI 19140'
- any other antimicrobial preservative(s)
- benzoic acid, calcium benzoate, potassium benzoate or sodium benzoate
- a statement of the purpose or purposes of the product
- The purpose of the product can generally be made obvious by it being called a 'sunscreen' or 'moisturiser with sunscreen' or 'moisturiser' with an SPF stated on the label.
- If (and only if) a therapeutic sunscreen has an SPF of 30 or higher and it provides broad spectrum protection, the label is permitted to include a representation to the effect 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 (see Gazette notice of 25 September 2002). Other acceptable related claims are 'can aid in the prevention of solar keratoses' and 'can aid in the prevention of sunspots'.
- Any broad-spectrum sunscreening preparation with an SPF of 4 or higher may also make the claim 'can aid in the prevention of premature skin ageing' or words to that effect.
- The labelling of therapeutic sunscreens may also carry justified non-therapeutic claims.
- directions for use of the product
- Note: The directions for use for a primary therapeutic sunscreen should include statements to the effect that the product should be applied to the skin in generous amounts over all of the exposed areas 20 minutes before sun exposure, it should be reapplied every two hours or more often when sweating, and should be reapplied after swimming or towelling. The labelling must not contain a claim (for example, 'all day protection') that indicates or implies that the product does not need to be reapplied at regular intervals.
- required warning statements as included in the RASML
- Note: The labels of both primary and secondary therapeutic sunscreens should include warning statements to the effect that the product should be kept out of the eyes and should not be used on broken, damaged or diseased skin. Spray-sunscreens should also include a warning not to inhale the product.
- Primary therapeutic (but not secondary) sunscreen products should also include warning statements to the effect that prolonged exposure to the sun should be avoided, and it is important to wear protective clothing, hats and eyewear when exposed 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.
4.3 Minimum requirements for small containers
In accordance with subsection 3(11) of the Labelling Order, if the immediate container has a capacity of 20mL or less AND the container is enclosed in a primary pack (for example, carton), the primary pack labelling must include all of the information listed above and the labelling on the container must include at least the following information:
- product name (in full or in abbreviated form if there is insufficient room for the full name)
- name of the dosage form
- quantity of product in the container
- batch or lot number preceded by the batch number prefix
- names and quantities of all active ingredients in the product. If there is insufficient room, this information about active ingredients is only required on the label of the primary pack.
4.4 Nanoparticles in sunscreens
Nanoparticulate titanium dioxide and zinc oxide are commonly used in sunscreens. The labels of therapeutic sunscreens are not required to declare the particle size of ingredients.
The TGA's policy on the safety of nanoparticulate ingredients in sunscreens is available from the TGA Internet site.
4.5 Advertisements for therapeutic sunscreens
Advertisements for therapeutic sunscreens are required to comply with the Therapeutic Goods Advertising Code.