THERAPEUTIC AND COSMETIC SUNSCREENS

Introduction
Sunscreen legislation and Sunscreen Standards in Australia are the most complex in the world. Marketers need to be aware that:

a. Sunscreens must comply with the AS/NZ52604 2012 requirements. This standard separates sunscreens into primary sunscreens and secondary sunscreens based on purpose.

b. The overall presentation and purpose of a product should be taken into account in classifying a sunscreen product to be a primary or secondary sunscreen product.

c. The decision on whether a sunscreen is a primary or secondary sunscreen comes before taking into account where the product is a moisturiser, or a makeup product or a lip product.

d. Product labelling needs to clearly distinguish between primary and secondary sunscreens.

e. All primary sunscreens are therapeutic products.

f. Sunscreens that are not primary sunscreens are secondary sunscreens and these are divided into three groups –

      • Secondary Sunscreen – Skin Care which are therapeutic products over SPF15 to SPF50+
      • Secondary Sunscreen – Skin Care which are cosmetic products up to and including SPF15
      • Secondary Sunscreen – Colour Cosmetic and Lip Products which are cosmetics up to SPF50+

A summary of sunscreen classification can be found here:

TABLE OF SUNSCREEN TGA NICNAS SPF BROADSPECTRUM TESTING FOR TGA AICIS NICNAS - AU AND NZ
Click to enlarge

Therapeutic Sunscreens
If you are interested in the requirements for importing or manufacturing therapeutic sunscreens please click here.

Therapeutic sunscreens have the following requirements

  • They must be made in a TGA approved facility. Local facilities are inspected by the TGA and give a GMP license for 1-3 years if approved. Overseas facilities may qlualify for GMP Clearances depending on the country
    • i. for MRA arrangements (Singapore and Canada). TGA fees <$1000;
    • ii. for desk audits where inspection reports, SOPs and other documents are submitted and evaluated by TGA (USA and New Zealand). TGA fees ~$5000
    • iii. Other facilities will require inspections by TGA (Europe, Asia and Africa). These inspections may cost approximately $50,000 every 1-3 years.

b) All the ingredients must be known to the TGA and be on a list known as Therapeutic Products (Permitted Ingredient) Determinations 2020. This list is regularly updated approximately 3-4 times per year. Ingredients not on the list will need to be evaluated for safety and approved by the TGA.

c) All product formulas and claims need to be approved by the TGA and a number (AUSTL xxxx) assigned to be displayed on packs.

d) Sunscreens only have a limited number of therapeutic permitted indications that they can make and approved by the TGA. Therapeutic sunscreen products can also make cosmetic claims such as moisturising.

e) Other items include: unique labeling pharmacovigilance and therapeutic product recall adherence and stability tests.

f) SPF Testing in accordance with ISO24444 and UVA Broadspectrum Testing in accordance with ISO24443.

Cosmetic Sunscreens
If you are interested in the requirements for importing or manufacturing therapeutic sunscreens please click here.

Cosmetic sunscreens have the following requirements

a) Must meet the definitions for cosmetic sunscreens according to the Standard.

b) Cosmetic sunscreens ingredients are also mixtures of individual chemicals and hence need to meet all the introduction requirements of the regulator, Australian Industrial Chemical Introduction Scheme (AICIS).

c) All the other requirements in regard to ingredient labeling for cosmetics, unit measure, placement size, country of origin and poison standards apply.


Our expertise
Engel Hellyer & Partners’ Directors have been participating members in the development and updating of the Australia and New Zealand Sunscreen Products Standard since 1977. The first standard was commissioned to the Federal Government and issued in 1983. The seventh revision of the standard is currently under way.

Sunscreen classification and claims restrictions require expert guidance which we are well placed to provide.

Please feel free to contact us to discuss your requirements further.