Australia and New Zealand · Summer product compliance
Is your sunscreen ready for sale? Check the SPF evidence, label and claims
Sunscreen is not ordinary seasonal merchandise. Before it is imported, stocked, labelled or promoted, the exact product needs the correct regulatory pathway and reliable evidence for every SPF, broad-spectrum and water-resistance claim.
The practical lesson
Do not place sunscreen on sale until the exact product, evidence, label and claims have been checked.
The compliance task is not limited to confirming that a supplier has sent an SPF report. A business needs to know which regulatory pathway applies, who is legally responsible, whether the evidence relates to the product actually supplied, whether the label matches the authorised or tested product and whether every customer-facing claim remains supportable.
These checks apply to established brands as well as imported, exclusive and private-label ranges. A product can create problems even when its base formula has been used elsewhere or an AUST number appears on the Australian label.
In March 2026, the TGA reported that 19 sunscreens using the same base formulation as a product associated with lower-than-claimed SPF results had been cancelled from the ARTG and recalled. Listed products are not necessarily tested by the TGA before sale: the sponsor certifies compliance and must hold the supporting evidence.
Start with classification
Not every product carrying SPF follows the same pathway.
The product’s primary purpose, ingredients, SPF, intended use and presentation determine which requirements apply. Do not classify a range from the word ‘sunscreen’ alone or assume that the Australian answer automatically applies in New Zealand.
Primary sunscreens
Products represented primarily as protecting skin from ultraviolet radiation are regulated. In Australia they will generally need to be included in the ARTG before supply. In New Zealand they fall within the mandatory sunscreen product safety standard.
SPF skin care
Moisturisers, oils, creams and gels can move into a regulated sunscreen pathway when their SPF and presentation cross the relevant threshold. Australia and New Zealand do not use an identical classification pathway, so check each market separately.
Combination products
Insect repellents, cosmetics, tinted products, lip products and other secondary sunscreens require a product-specific assessment. The formulation, intended use, SPF and marketing presentation can change the result.
A moisturiser, foundation, lip product or insect repellent with an SPF claim may be included, excluded or regulated differently depending on the exact product and market. Confirm the classification before deciding what testing, listing, label or advertising pathway is required.
Australia
Therapeutic sunscreens generally need to be in the ARTG before supply.
Primary sunscreens and some secondary sunscreens are therapeutic goods. The TGA identifies sunbathing and moisturising skin-care products with an SPF over 15 as examples of secondary sunscreens that may require inclusion in the ARTG. Some cosmetic secondary sunscreens are excluded, but the exclusion needs to be checked against the exact product and presentation.
Most therapeutic sunscreens supplied through the listed-medicine pathway display an AUST L number. Listing is not the same as TGA pre-market approval of the product’s safety, quality and effectiveness. The Australian sponsor certifies that the product meets the applicable requirements and remains responsible for matters including permitted ingredients and indications, manufacturing, SPF evidence, labelling and advertising.
- Search the ARTG. Confirm the AUST number, product name, sponsor and indications against the product that will actually be supplied.
- Check manufacturing. Therapeutic sunscreen manufacturing, including relevant finished-goods labelling activities, must follow the applicable TGA manufacturing and GMP pathway.
- Reconcile the evidence. Confirm that the formulation, test sample and product on sale are the same, or that any reliance on shared evidence is scientifically and legally justified.
- Review changes. A new name, indication, formula, manufacturer, label or presentation can require regulatory action before the changed product is supplied.
New Zealand
A mandatory product safety standard applies to manufacturers, importers and suppliers.
The Sunscreen (Product Safety Standard) Act 2022 makes AS/NZS 2604:2012 the mandatory product safety standard for covered sunscreen products. Commerce Commission guidance states that businesses manufacturing, importing or supplying those products in New Zealand must comply.
The statutory definition includes products represented primarily as protecting skin from ultraviolet radiation, insect repellents carrying a labelled SPF of 4 or more and skin-care products carrying a labelled SPF greater than 15. The skin-care category excludes products intended for the lips and products represented primarily as a tinted base or foundation.
For manufacturers and importers, the Commerce Commission recommends independent testing before supply. Labels must meet the product-specific marking requirements, including durable and legible SPF information and clear directions for use. Fair Trading Act obligations also apply to SPF, broad-spectrum, water-resistance and other performance representations.
SPF and claim evidence
The evidence must remain reliable throughout supply.
In Australia, sponsors must hold evidence supporting the SPF indications at all times. The TGA may request it while the sunscreen remains in the ARTG and has said that it considers the testing standard, laboratory accreditation, supporting documentation and the totality of evidence where results conflict.
In New Zealand, a supplier also needs reasonable grounds for its claims when they are made. In 2022, an Australian sunscreen company was fined NZ$280,000 after adverse SPF results and concerns about the testing facility meant it no longer had a reasonable basis for certain SPF50+ claims. The Commerce Commission emphasised that substantiation is an ongoing obligation.
Check the test standard, laboratory, accreditation, report date, sample identity, formulation, batch or variant coverage and any later evidence that calls the result into question. Conflicting results need to be assessed, not filed away.
Private-label and customised products
Using an existing formula does not automatically give a new brand a compliant route to market.
The TGA has specifically warned about white-labelled sunscreens carrying an AUST number where the product name or indications on the label do not match the ARTG entry. If those details do not match, the product is not treated as being included in the ARTG merely because the number itself exists.
Before applying a new name, label or claim to an existing formula, confirm:
- who will be the Australian sponsor and who holds the relevant ARTG entry;
- whether the exact product name and every indication will match that entry;
- whether a new listing or variation is needed before supply;
- whether relabelling is being carried out through the required manufacturing pathway;
- whether the SPF and other testing evidence applies to the exact finished product; and
- whether the New Zealand importer or supplier separately holds the evidence needed for the mandatory standard and its claims.
Labels, websites and advertising
Review every place the protection claim appears.
Australian therapeutic sunscreen labels need the required product and ARTG information, ingredients, directions, warnings, SPF, protection level and UV protection information. Advertising must comply with the therapeutic-goods advertising framework as well as the Australian Consumer Law.
New Zealand’s mandatory standard controls testing and marking for covered products, while the Fair Trading Act prohibits misleading and unsubstantiated representations. The Commerce Commission’s business guidance identifies restrictions affecting claims such as ‘sunblock’, ‘waterproof’, excessive water-resistance periods and protection claims that do not match the standard.
Check the physical label together with the website, marketplace listing, catalogue, point-of-sale material, social posts, testimonials, influencer content and customer-service statements. Do not assume a disclaimer or link will correct a prominent unsupported headline.
Before ordering, listing or sale
Build one file that connects the product to the evidence and customer claims.
- Classify the exact product separately for Australia and New Zealand.
- Identify the sponsor, manufacturer, importer, distributor and retailer responsibilities.
- Check the ARTG entry and AUST number where the Australian product requires inclusion.
- Match the formulation, manufacturer, product name, indications, test sample and stock.
- Verify SPF, broad-spectrum and water-resistance evidence and the testing laboratory.
- Review every label element, direction, warning and mandatory statement.
- Test website, marketplace, social and influencer claims against the approved evidence.
- Confirm expiry, storage, traceability, complaints, adverse-event and recall controls.
- Set a process for responding to new or conflicting test information.
Official sources
Use current regulator guidance and the applicable legal instruments.
Australia
- TGA: sunscreen regulation in Australia
- TGA: March 2026 listed-medicine compliance update
- TGA: sunscreen labelling and white-labelling statement
- TGA: SPF testing evidence and laboratory considerations
- TGA: therapeutic sunscreen labelling and advertising
New Zealand
Practical support
Have the product and evidence reviewed before the summer range goes live.
Watchdog can assess sunscreen and SPF skin-care products for Australia and New Zealand, identify the applicable regulatory pathway, review ARTG and supplier information, reconcile SPF and other testing evidence, and check labels, websites and promotional claims.
Send us the product details, proposed markets, label artwork, test reports and supplier information. We can identify what applies and what needs to be resolved before sale.
Important information
This update provides general information as at 1 September 2026. The applicable requirements depend on the exact product, formulation, claims, supply role and market. Obtain advice on the specific product before relying on this summary.
Sunscreen compliance review
Check the product before the summer campaign begins.
Watchdog can review the regulatory pathway, product evidence, label and customer claims for Australia and New Zealand.