Australian sunscreens are a bit unusual. A few people have recently asked me why Australian sunscreens often don’t show a full ingredients list, and why some sunscreens get downgraded from high SPFs to SPF 15 once they hit the Australian market. There’s also the fact that some Australian sunscreens have questionably low SPF ratings, and why some companies just can’t be bothered bringing their sunscreens to the Australian market.

It’s to do with how the Australian Government has chosen to regulate some sunscreens – which I think is generally a great approach, but it does have some weird implications.

Note: This is my unqualified opinion as a skincare nerd / cosmetic chemist – I’m not a lawyer, so don’t rely solely on this if you’re looking to launch an SPF product in Australia!

For more information on sunscreens in general, check out the free sample chapter of The Lab Muffin Guide to Basic Skincare.

Therapeutic vs cosmetic sunscreens

In Australia, SPF-containing products are divided into therapeutic sunscreens and cosmetic sunscreens.

Therapeutic sunscreens include:

• Primary sunscreens (i.e. products that are marketed to be used primarily as UV protection) higher than SPF 4
• Moisturisers with SPF higher than 15

In other words, these are the serious sunscreens that you’d rely on to protect you from the sun. These are classified as therapeutic goods (i.e. medications or drugs), so they’re regulated by the Therapeutic Goods Administration (the TGA – similar to the FDA in the US, but the drug part only).

(Sunscreens containing some specific ingredients are also regulated: insect repellent, human-derived ingredients, and… animal organs.)

Cosmetic sunscreens are everything else, including:

• lip products with SPF higher than 4
• foundations with SPF higher than 4
• moisturisers with SPF 15 or lower (under 300 g or 300 mL)
• sunbathing skin care products with SPF between 4 and 15 (under 300 g or 300 mL)

These are regulated like regular cosmetic products:

• the Australian Competition and Consumer Commission (ACCC) regulates safety and labelling
• the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) regulates the ingredients

So to avoid classification as a therapeutic sunscreen (and therefore avoid a lot of administrative costs and hurdles, which are sometimes difficult to overcome), a product can classify itself as a moisturiser with an SPF 15 (the most common situation in my experience). However, this means that the product has to be marketed so that it’s clear that its primary purpose is NOT as UV protection, so that consumers aren’t led to rely on a substandard product to protect against the sun – a line which I think is sometimes overstepped.

TGA Regulation

Therapeutic sunscreens need to be listed or registered with the TGA. The vast majority of the time, sunscreens are listed, which has less strict requirements compared to registration (sunscreens are considered lower risk than many other medications out there). However, these regulations are still much stricter than for cosmetic sunscreens.

Sunscreens that make extra therapeutic claims, like reduction of free radicals or immune suppression, need to be registered with the TGA rather than just listed.

Therapeutic sunscreens that are legally allowed to be marketed in Australia can all be found in the Australian Register of Therapeutic Goods (ARTG). My quick check of the ARTG didn’t find any registered SPF products, only listed ones.

The ARTG listing or registration number needs to be printed on the packaging. This is in the format “AUST L [number]” (for listed sunscreens) or “AUST R [number]” (for registered sunscreens):

UV Protection

The main requirement for a therapeutic sunscreen to be listed is that the SPF factor has to be tested according to the AS/NZS 2604:2012 standard, which requires testing on a minimum of 10 human subjects in accordance with the international ISO 24444:2010 standard. The results also need to be consistent for the sunscreen to be listed. Any changes to the formula that might affect SPF (including changes to the inactive ingredients) means the sunscreen must be tested again, and often means it’ll need a new ARTG listing number.

Only certain SPF numbers are allowed for therapeutic sunscreens: 4, 6, 8, 10, 15, 20, 25, 30, 40, 50 and 50+.

Related post: What Does SPF Mean? The Science of Sunscreen

Additionally, broad spectrum UVA protection is mandatory for:

• all therapeutic sunscreens regulated by the TGA
• cosmetic sunscreens with SPF 30 or higher

For a sunscreen to be broad spectrum, it has to pass both the critical wavelength >370 nm and UVAPF/SPF ratio >1/3 tests (more info on this in my post on Why you should protect your skin from UVA (and how) (with video)).

Tested water resistance claims can also be included as well.

Active ingredients

Therapeutic sunscreens are limited to using only the permitted active sunscreen filters at the allowed range of concentrations. The safety of these filters (when used at the allowed concentrations) has been assessed by the TGA, so the safety and efficacy of the final formula isn’t evaluated by the TGA for listed sunscreens. The TGA does tell brands to consider the safety of the inactive ingredients in the sunscreen, and ensure that the sunscreen is safe for use in the sun. The TGA also reviews a small selection of listed products each year.

Ingredient lists

In Australia, like many other countries, the ingredients of cosmetic products have to be listed in order of highest to lowest mass or volume. Ingredients that are at less than 1% concentration and colour additives can also be listed at the end instead, in any order. Either the English or International Nomenclature Cosmetic Ingredient (INCI) names can be used. For cosmetic products, exact percentages don’t have to be listed.

However, therapeutic goods are exempted from these labelling requirements. Instead, they have to follow the special labelling requirements for therapeutic goods in Australia. This means that the Australian Approved Names of all of the active ingredients have to be listed, along with the proportions used in the product. This is generally given as a weight percentage (%w/w or %w/v) or a weight concentration per unit product (milligrams per gram (mg/g) or milligrams per mL (mg/mL).

Along with active ingredients, some other ingredients need to be listed if they’re in a therapeutic product:

• Certain preservatives:
  • benzoates (benzoic acid, calcium benzoate, potassium benzoate or sodium benzoate)
  • hydroxybenzoate esters (ethyl, methyl, propyl, sodium ethyl, sodium methyl, sodium propyl hydroxybenzoates)
  • sorbates (sorbic acid or potassium sorbate)
  • sulfites (sulfite, metabisulfite and bisulfite salts and sulfur dioxide)
  • ethanol, if present at over 3% v/v
  • any other antimicrobial preservatives
• peanuts and peanut products (e.g. peanut oil, arachis oil)
• other ingredients listed in Schedule 1 of TGO 69

So on the one hand, we don’t always get a full ingredients list for Australian sunscreens (annoying if you’re sensitive to a particular ingredient in the base). On the other hand, we do get to know the exact percentage of each sunscreen filter, which is good if you’re sensitive to them but only at high quantities.

Very rarely, some sunscreen brands have decided to release the full ingredient lists for their products (e.g. Ultra Violette). While this is amazing for us consumers, it does also place the brand at a competitive disadvantage, since other brands can more easily dupe their formulas. Ideally, I’d like if all therapeutic sunscreens had to provide full ingredient lists as well, since they’re used in similar ways to other cosmetics.

UPDATE: The full ingredient lists are now available via the TGA’s Australian Register of Therapeutic Goods (ARTG) database! They’re in alphabetical order, and they use International Non-proprietary Names (INNs) rather than INCI names so they sometimes look a bit weird, but they’re there!

Expiry date and batch number

An expiry date also needs to be printed on the packaging for therapeutic sunscreens. To work out the expiry date, manufacturers need to test the finished product in the intended container. The product is either left at the recommended conditions for the real amount of time (e.g. 30 °C for 2 years) or at equivalent accelerated testing conditions (e.g. 30 °C for 2 years is considered to be equivalent to 40 °C for 6 months).

The product is checked to ensure that there aren’t any microorganisms that have grown to unsafe levels (microbiological stability). It’s also checked for physical stability (whether there are any changes to its appearance, odour or texture, and whether it degrades the container) and chemical stability (pH changes, or if the active ingredients break down).

The batch number of the sunscreen also needs to be printed on the container, so any irregularities can be traced.

Cosmetic sunscreens also often have expiry dates and batch numbers, and good manufacturers will also perform similar stability tests – but this isn’t mandatory, and brands may skip this test for cost-cutting reasons, or to rush a product to market faster.

Manufacturing

Therapeutic sunscreens also need to be manufactured according to the Good Manufacturing Practice code. This covers things like standards for raw ingredients, product quality and stability testing, and the facilities where therapeutic goods can be manufactured. This is often an issue for overseas manufacturers, since getting TGA approval for an overseas facility can be very difficult.

Other requirements

I’ve only really listed the requirements that are relevant for us as skincare consumers here. There are other regulations, like the words that can’t be used on sunscreens (sunblock, waterproof, sweatproof), and requirements for reporting adverse reactions.

There’s also a requirement that sunscreens can’t suggest that they don’t need reapplication (e.g. “all day protection”). This means that even with improvements in technology that allow longer wear, this claim can’t be made – so unfortunately it does mean that this probably isn’t an area of innovation that Australian sunscreen manufacturers will be investing in.

Hopefully this was an interesting insight into the regulations surrounding sunscreen, and the implications for the types of products we see on the market!

References

Therapeutic Goods Administration, Australian regulatory guidelines for sunscreens (ARGS) Version 1.2 (last updated 30 August 2019, current version as of 19 Jan 2020)