4 facts about Australian sunscreen regulations

by | Aug 3, 2019 | Compliance/Legislation, Therapeutic Claims | 0 comments

Sunscreens are a highly regulated product in Australia. And it’s no surprise why – approximately two in three Australians will be diagnosed with skin cancer by the time they’re 70 (source: Cancer Council).

But unfortunately there’s a lot of misinformation out there about the requirements for making and selling sunscreen. So I want to set the facts straight, so you (and your customers) don’t get burned.

FACT #1 – Cosmetic sunscreens and therapeutic sunscreens are different

In Australia, two main factors are considered when determining if a sunscreen is cosmetic or therapeutic:

  1. Whether the product is advertised with the primary purpose of being a sunscreen (i.e. a primary sunscreen) or secondary purpose (i.e. a secondary sunscreen), AND
  2. The SPF (sun protection factor) of the product.

Cosmetic sunscreens are secondary sunscreens, which are advertised as having a primary purpose other than sun protection. These include products such as:

  • Moisturisers with SPF 15 or less (in pack sizes of 300mL/300g or less);
  • Sunbathing skin care products (e.g. oils, creams, gels, sunless tanning products and after-sun care products) with SPF 15 or less (in pack sizes of 300mL/300g or less);
  • Lip products with SPF; and
  • Tinted bases and foundations (e.g. liquids, pastes or powders) with SPF.

Therapeutic sunscreens are usually primary sunscreens with SPF 4+, e.g. sunscreens with SPF 30 or 50. If it’s a sunscreen that’s also an insect repellent it’s also deemed therapeutic, regardless of whether it’s a primary or secondary sunscreen.

Therapeutic sunscreens need to be approved by the TGA. Cosmetic sunscreens don’t.

See the TGA website for more information on what sunscreens needs to be included on the ARTG (Australian Register of Therapeutic Goods).

FACT #2 – ALL products need to be tested to make sun protection claims

Legally you can’t make any claims about sun protection if you don’t have specific evidence to support your claims. To have sufficient evidence to make this claim you need to send the product for SPF testing in accordance with the Australian Standard on sunscreens. Dermatest is the main Australian company that offers SPF testing.

Importantly, this is 100% required by law regardless of whether it’s a cosmetic or therapeutic sunscreen. Please don’t make any kind of sun protection claims until you’ve tested your products! (note: this is not just limited to SPF claims, but any kind of claims that give customers the impression a product will protect their skin from the sun).

FACT #3 – You can’t believe everything you read on the Internet

One of my pet peeves (as you probably know by now) is the misinformation out there on the World Wide Web. Like articles about certain carrier oils, such as red raspberry seed oil, claiming they have SPF benefits. A lot of these claims aren’t based on reliable research,  and if you search you’ll easily find information that refutes these claims.

I came across this interesting article – a real-life test of different oils versus sunscreen – and guess what came out on top? Yes, it’s not an official study but it’s a good visual example of the difference in effectiveness between them.

Please don’t estimate the SPF of your products based on the ingredients you’ve included – it’s not as simple as that. And just because you have zinc oxide in a product, doesn’t mean it’s going to be an effective sunscreen unless the product is properly formulated (e.g. to prevent flocculation, where minerals drop to the bottom of oil-based formulas). This is why lab testing is required for all sunscreen products.

FACT #4 – Sunscreen is serious business

I want to reiterate that sunscreens are serious business – you should never find a DIY recipe on the Internet and think you can immediately start selling it to customers. I know a lot of people are passionate about creating natural sunscreens for themselves and customers – but you need to balance that with what is safe. In this space, it’s better to be safe than sorry. This is for the protection of your customers (and their skin) and your business.

Check out this news article about legal action Banana Boat faced for allegedly making incorrect SPF claims – the claims were eventually dropped but not without a lot of negative media first (and no doubt some costly legal fees).

As you can tell, this is another regulatory topic I’m passionate about sharing with you, so I hope you’ve learned something (even if it’s that you never want to make a sunscreen because it’s too difficult). There are also a number of other claims and label requirements not mentioned above that apply specifically to cosmetic sunscreen products.

Want to see how much you really know about cosmetics regulations? Test your knowledge with my Cosmetics Compliance Quiz!

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Jennifer Rudd Skincare Business Foundations 28

Hi, I'm Jen

Founder of Skincare Business Foundations, I help skincare and beauty founders build compliant and ethical brands that last.


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