Sunscreen Regulations

Last Update 3rd November 2021

ALL SUNSCREENS SUPPLIED IN AUSTRALIA MUST BE TESTED TO THE AUSTRALIAN STANDARD.

This testing involves 10 human test volunteers as well as Broad Spectrum testing(see chart below) and may additionally involve water resistance testing (up to 4 hours) if this is to be claimed. The standard – AS/NZS 2604 (2021) involves changes to the requirements. The adoption of these changes was completed by TGA in June 2021. The test methods for SPF and UVA (Broad Spectrum) are ISO 24444 and ISO 24443.

http://www.tga.gov.au/industry/sunscreens-args.htm

Classification of Sunscreens for Australia (Final June 2021)

Water Resistance Claims
A copy of the Standard can be obtained from… SAI Global InfoStore Search : AS/NZS 2604:2021

Primary Sunscreens
These are products with the primary purpose of sun protection. If the SPF is above 4, these must be ‘Listed’ with TGA before supply to the market.

TGA Listing of Primary Sunscreens
A list of regulatory consultants who can assist with this Listing can be found at Association of Therapeutic Goods Consultants

Stability Testing of Sunscreens
Requirements for this can be found on http://www.tga.gov.au/industry/sunscreens-args-07-stability.htm

If you require stability testing, see… www.eurofins.com.au/dermatest/analytical-chemistry/stability/

Secondary Sunscreens – Last update July 2017
Apart from Primary sunscreens, almost all cosmetic products are not regulated as Therapeutics. Generally, they fall into two sub-groups – Skin Care (e.g Moisturisers) and Colour and Lip (mostly colour cosmetics but including clear lip products). Detailed guidance on this can be found at www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-sunscreen

Some products containing sunscreen actives are defined as Secondary Sunscreens and are considered to be cosmetics. These are products for which the primary usage purpose is not as a sunscreen. – Therapeutic Goods (Excluded Goods) Orders [Nos. 1 and 2] Therapeutic Goods Excluded Orders

Secondary Moisturisers can only be labelled up to SPF 15. For a product labelled SPF15, the tested protection factor must be in the range 15-29 (inclusive). See: www.industrialchemicals.gov.au/cosmetics-and-soap/cosmetics-sunscreen

These products are regulated by AICIS and are defined under the following criteria:

• Moisturisers that contain a sunscreen as and for a SECONDARY PURPOSE where the SPF ³4 and does not exceed 15 provided:
• they meet the definition of “secondary sunscreen product” as defined in AS/NZS 2604 and
• Any SPF or equivalent category description is disclosed on the label; and
• the SPF or equivalent category description disclosed on the label is determined by the method prescribed by AS/NZS 2604 for the precise formulation; and
• the formulation is not water-resistant; and
• there is an expiry date or use by date on the label if the product is not stable for at least 36 months; and
• no therapeutic claims, including any representation about skin cancer, are made; and
• any representation about anti-ageing can be made only if the product is defined as a “broad-spectrum product” within the meaning of AS/NZS 2604; and
• the pack size does not exceed 300 mL or 300 g; and
• all performance statements and markings (both “mandatory” and “optional”) are expressed on the product label in the manner prescribed by AS/NZS 2604: and no other; and
• labeling, marketing and packaging clearly indicates the product is for use as a cosmetic.

Tinted facial make-up or lipstick
These are generally secondary sunscreens. See above.

Listing of sunscreens (Primary Sunscreens)
The majority of sunscreen products require listing in the ARTG. Products are eligible for listing where…

The claimed SPF has been tested according to AS2604 and is greater than 15; and

The product does not make a ‘prohibited’ or ‘restricted’ representation as defined in Appendix 6 to the Therapeutic Goods Advertising Code and

The labeling complies with AS2604:1998, the Labelling Order and the Therapeutic Goods Advertising Code

Permitted Actives and Concentrations
Listed sunscreen products can only contain active ingredients that are included in the list of Sunscreening agents permitted as active ingredients in listed products in ARGS within the maximum concentrations stated in the list.

Registerable products containing a Sunscreen.
Sunscreen products that make therapeutic claims other than sunscreening or contain active ingredients that are not included in the list of Sunscreening agents permitted as active ingredients in listed products are not “sunscreen preparations” and must be fully Registered with TGA, rather than Listed.

Labelling of sunscreens
The labeling of Primary sunscreen products must comply with:

• The Labeling Order (Therapeutic Goods Order No. 91 and 92)
• The Therapeutic Goods Advertising Code
• Australia/New Zealand Standard AS/NZS 2604 (2021)

Mandatory (as relevant for your product) requirements for the labeling of sunscreens under AS2604:2021 are:

• Category description
• Specifications for the declaration of the SPF
• Broad spectrum claims
• Water resistant claims.

For broad spectrum products with SPF of 30, other statements related to premature ageing and reduction of risk of skin cancer are also permitted, provided that the product label highlights the need for avoidance of prolonged exposure to the sun and the importance of wearing protective clothing, hats and eyewear.

The labels of all sunscreen products should:

• (as appropriate) Advise consumers to apply generous an appropriate amounts of sunscreen over all exposed areas 15 to 20 minutes before sun exposure, and again after swimming or toweling.
• Highlight the need for avoidance of prolonged exposure to the sun and the importance of wearing protective clothing, hats and eyewear.
• Advise consumers to keep the product out of the eyes.

Other Useful Documents

GMP Licenced Manufacture information http://www.tga.gov.au/industry/manuf.htm#.U88Krcar3Hg

TGA Fact Sheet: Sunscreens – http://www.tga.gov.au/industry/sunscreens.htm#.U88K3sar3Hg