TGA Sunscreen Recall 2025: Are Natural Sunscreens Affected?
Short answer: “Natural” or mineral sunscreens are not automatically exempt from recalls. In Australia, sunscreen recalls are based on whether a product delivers the SPF on its label — not on whether the UV filters are mineral or “chemical”. The 2025 TGA recall is a reminder that testing and compliance, not marketing language, are what ultimately matter.
Latest TGA update — December 2025: The Therapeutic Goods Administration (TGA) has announced a batch-level recall of Cancer Council Sunscreen Clear Zinc Kids SPF50+ 110 g after identifying a manufacturing issue that may cause the product to separate and deliver less than the stated SPF. Affected batch numbers are 1143730 (exp Aug 2027), 1141313 (exp Jun 2027) and 1146857 (exp Nov 2026). If you have a tube from these batches, stop using it and contact the retailer or sponsor for a refund or replacement.
The 2025 recall by Australia’s regulator followed independent testing that showed some sunscreens were providing lower-than-claimed SPF levels. That’s unsettling, especially for shoppers who actively choose “natural” formulas for sensitive skin or reef considerations. But here’s the clear message: the recall is about performance versus the label, not about punishing one filter type. A product can be mineral, vegan, fragrance-free, reef-considered—and still fail if its SPF doesn’t meet the number on pack across stability and real-world use. Equally, a well-made mineral sunscreen can pass with flying colours. The system is designed to protect consumers by verifying claims, removing underperformers, and maintaining trust in Australian sunscreens.
So, are natural sunscreens affected? They can be, if the specific batch tested falls short; but being “natural” doesn’t make a product inherently risky or safe. What matters is whether the sunscreen is TGA-listed or registered (AUST L / AUST R), manufactured under Good Manufacturing Practice (GMP), and supported by reproducible SPF and stability data. The TGA’s framework—covering testing, permitted ingredients, labelling, and post-market surveillance— applies to everyone. As a shopper, your best move is to check the label for AUST codes and expiry, choose the texture you’ll apply generously and reapply, and stick with brands that are transparent about testing under Australian conditions.
Key Takeaways at a Glance
Sources: TGA (sunscreen recall notices, Oct & Dec 2025); TGA (Sunscreens—regulation overview).
What triggered the recall?
The Therapeutic Goods Administration (TGA) withdrew specific sunscreen batches only after independent laboratory testing found that their SPF performance was lower than the label claim. This action wasn’t about shaming brands—it was a consumer protection measure designed to preserve public trust in Australia’s sunscreen market.
When a product underperforms, it triggers a batch-level recall, meaning only those particular production runs are affected. The sponsor (the company responsible for the product) must then investigate the cause, reviewing the entire manufacturing chain: raw material quality, particle size of UV filters, dispersion stability, packaging integrity, and testing reproducibility.
If an ingredient batch degraded under heat or humidity, or if the formulation separated during storage, the SPF protection could drop below its labelled rating—even if earlier tests passed. That’s why the TGA requires ongoing post-market testing, not just pre-approval results.
It’s important to note that a recall doesn’t imply that all sunscreens—or all mineral sunscreens—are flawed. Instead, it shows that the regulatory system is actively working: identifying issues early, removing products that don’t meet their claims, and ensuring that future batches meet Australia’s exacting UV protection standards before returning to shelves.
How sunscreens are regulated in Australia
Australia treats therapeutic sunscreens seriously because our UV index is among the highest in the world. Under the Therapeutic Goods Act, any product that claims to prevent sunburn or reduce the risk of skin cancer is classified as a therapeutic good, not a cosmetic. This means it must be evaluated and listed on the Australian Register of Therapeutic Goods (ARTG), displaying either an AUST L or AUST R number on its label.
To earn that number, sponsors must comply with the Australian Regulatory Guidelines for Sunscreens (ARGS) — a detailed framework that governs everything from UV filter selection and testing reproducibility to stability under heat and light, manufacturing quality, and labelling claims. It ensures that every sunscreen sold as “SPF 30” or “SPF 50+” can back up that claim with robust, repeatable data.
Formulation testing must be conducted using recognised ISO or AS/NZS methods, and water-resistance claims require validation through timed immersion trials. Manufacturers must also operate under Good Manufacturing Practice (GMP) — the same quality standard applied to medicines — and maintain documentation for post-market review.
Advertising rules are equally strict. Sunscreen brands can’t make unproven therapeutic or cosmetic claims such as “blocks all UV” or “chemical-free.” By enforcing these standards, the Therapeutic Goods Administration (TGA) protects consumers from misleading marketing and helps ensure that every SPF label sold in Australia reflects real-world protection under local conditions.
| Category | Label | What it means |
|---|---|---|
| Listed | AUST L xxxxx | Uses pre-approved UV filters; must pass SPF and water-resistance testing; complies with ingredient limits. |
| Registered | AUST R xxxxx | Makes therapeutic claims; undergoes full evaluation for quality, safety, and efficacy. |
Source: TGA (Sunscreens—regulation overview).
How to check if your sunscreen is affected (AU)
- Find the batch number on the tube or carton (often near the expiry/lot code).
- Compare against TGA Safety Alerts (search the brand + batch code).
- Action: If your batch appears in a recall, stop using it and follow the sponsor’s return/refund advice.
Heads up: Recalls are typically batch-specific. Other batches of the same product can remain fully compliant.
For example, as of December 2025, selected batches of Cancer Council Sunscreen Clear Zinc Kids SPF50+ 110 g have been recalled due to separation and reduced SPF performance. Only the specified batch numbers (1143730, 1141313 and 1146857) are affected; other batches of the same product remain compliant.
Choosing a compliant natural sunscreen in Australia
- ARTG code: Look for an AUST L/R number on-pack.
- Broad-spectrum & SPF 50+: The default for Australian UV levels.
- Texture you’ll reapply: Lotion/cream/stick you’ll use generously and often.
- Water-resistance: Choose 2–4 hr claims for beach/sport days.
- Sensitive skin: Fragrance-free mineral (zinc/titanium) is often better tolerated.
In Australia, sunscreen safety is about tested performance, not the marketing term on the tube.
SPF application: the amounts that actually work
- Face/neck/ears: ~½ teaspoon (the three-finger guide).
- Whole body: ~35 mL (about a shot glass).
- Reapply: Every 2 hours and after swimming, sweating, or towel-drying.
Water-resistant claims: what they really mean
When a sunscreen label says “water-resistant 2 hr” or “4 hr,” that claim is based on controlled laboratory testing, not everyday beach conditions. Products are immersed in water for specific time intervals—typically 2 or 4 hours—then re-tested to confirm they still provide the stated SPF level. To pass, the formula must maintain a minimum level of UV protection after the test, proving that its film remains stable on damp skin.
However, real life is far messier than a test tank. Factors like vigorous swimming, towelling off, sand friction, perspiration, and incomplete application can all break down that protective layer more quickly. Even a “4-hour water-resistant” sunscreen may lose effectiveness long before that time if it’s rubbed or washed off.
For reliable protection, dermatologists and the Cancer Council recommend reapplying every two hours, and immediately after swimming, sweating, or towel-drying— regardless of the water-resistance rating. Choosing a broad-spectrum, SPF 50+ sunscreen with a 2 hr or 4 hr water-resistance claim gives you a good safety margin, but consistent reapplication is what truly keeps you covered on high-UV, high-activity days.
Kids & sensitive skin
- Under 6 months: Seek GP advice; rely on shade, hats and UPF clothing.
- Young children: Broad-spectrum SPF 50+, fragrance-free, tear-friendly textures.
- Reactive skin: Patch test mineral formulas; avoid strong fragrance/essential oils.
- Check recalls: For children’s sunscreens, periodically check TGA safety alerts and your bottle’s batch number—especially if you notice changes in texture or separation.
Storage & expiry in Australian heat
- Keep below 30 °C: Don’t leave sunscreen in hot cars or beach bags.
- Check PAO/expiry: Replace when expired or if texture/odour changes.
- Batch record: Photograph the label (batch/expiry) for easy recall checks later.
“Reef-safe” in Australia: what’s official?
“Reef-safe” is often used on sunscreen packaging to suggest that a product is environmentally gentle, but in Australia it’s not an official or regulated term. The Therapeutic Goods Administration (TGA) does not assess sunscreens for marine or reef impact—its role is to ensure human safety and SPF performance. This means a product can be TGA-listed and completely compliant, yet still contain ingredients that some environmental groups choose to avoid.
If reef friendliness matters to you, start by confirming TGA compliance first—look for an AUST L or AUST R code—and then check the ingredient list for filters such as oxybenzone or octinoxate, which have been restricted in certain reef-sensitive regions overseas. In Australia, these ingredients remain legal and can be used within set limits. Choosing a mineral formula with zinc oxide or titanium dioxide in non-nano form is one option often preferred by eco-conscious consumers.
Ultimately, the priority is to use sunscreen you’ll apply generously and often. Skin cancer prevention outweighs theoretical environmental risks, so focus first on protection that meets Australian standards, then make environmentally aligned choices where possible. Responsible disposal—avoiding rinsing excess product directly into waterways—also helps minimise cumulative impact.
Mineral vs organic (“chemical”) filters: what actually matters
Mineral filters (zinc oxide, titanium dioxide) and organic filters (e.g., avobenzone, octocrylene) can both provide excellent protection when the product is well-formulated and generously applied. Sensitive-skin users often prefer mineral due to lower irritation potential, but efficacy depends on tested SPF, film formation, and reapplication.
Key point: The TGA recall focuses on whether SPF claims are met in testing. Filter type does not exempt a product from performance requirements.
How to read a sunscreen label (quick check)
- AUST L/AUST R: Confirms inclusion on the ARTG under TGA rules.
- SPF 30+ or 50+ & Broad-spectrum: UVB and UVA protection.
- Water-resistant claim: Must be validated by testing.
- Expiry & batch: Stability matters; heat shortens shelf life.
- Texture you’ll reapply: The best sunscreen is the one you’ll actually use generously.
Best TGA-listed natural sunscreens to consider
Once you’ve confirmed TGA compliance and checked your batch number, the next step is choosing a texture and format you’ll happily apply and reapply on real-world beach and school-run days. These natural, zinc-based formulas are popular starting points for families and sensitive skin.
SURFMUD Natural Zinc Tinted Covering Cream 45g
Wotnot Natural Sunscreen SPF 50+ 125g
Wotnot Natural Face Sunscreen 40 SPF Beige BB Cream 60g
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Quick myth-busting
- Myth: “Natural” means recall-proof. Reality: Any TGA-listed sunscreen can be recalled if a batch fails SPF testing. Do: Check for an AUST L/R code and your bottle’s batch number against TGA alerts.
- Myth: SPF 70 is way stronger than SPF 50. Reality: SPF 50 filters ~98% UVB; SPF 70 is ~98.6%. The gap is small. Do: Use enough product (≈35 mL for body) and reapply every 2 hours, and after swimming/sweating.
- Myth: Make-up SPF replaces sunscreen. Reality: Make-up is rarely applied at the tested dose (2 mg/cm²), so protection is patchy and lower. Do: Apply a dedicated broad-spectrum SPF, then make-up; top up with an SPF mist/stick.
- Myth: Mineral sunscreens “bounce off all UV.” Reality: Minerals mostly scatter/reflect but also absorb some UV; both mineral and chemical filters can achieve high SPF when well-formulated. Do: Choose the texture you’ll use generously; look for broad-spectrum and water-resistant when needed.
- Myth: One morning application lasts all day. Reality: Sweat, water and towel-drying reduce protection. Do: Reapply every 2 hours and after water exposure, regardless of SPF number.
Frequently asked questions about sunscreen recalls & regulation
Were natural or mineral sunscreens included in the 2025 TGA recall?
Yes. In Australia, any sunscreen that claims sun protection is regulated as a therapeutic good, regardless of whether it uses mineral (zinc oxide or titanium dioxide) or organic UV filters. The 2025 TGA recall targeted specific batches that failed SPF performance testing. “Natural” or mineral formulations are not automatically exempt from recalls.
Why are sunscreen recalls usually batch-specific?
SPF performance can be affected by formulation stability, raw material variation, heat exposure, or storage conditions. When testing identifies underperformance, the TGA recalls only the affected production batches rather than the entire product line. Other batches may remain fully compliant and safe to use.
What does an AUST L or AUST R number mean on sunscreen labels?
An AUST L or AUST R number confirms that a sunscreen is included on the Australian Register of Therapeutic Goods (ARTG). This indicates the product meets TGA requirements for permitted ingredients, manufacturing quality, and evidence supporting SPF and broad-spectrum claims.
Are imported sunscreens automatically compliant in Australia?
No. Imported sunscreens must still meet Australian regulatory requirements and carry an AUST L or AUST R number to be sold as therapeutic sunscreens. Products approved overseas are not automatically compliant under Australian law.
Are zinc oxide and titanium dioxide nanoparticles allowed in Australian sunscreens?
Yes. Zinc oxide and titanium dioxide, including nanoparticle forms, are permitted in Australian sunscreens. These ingredients have been reviewed for safety, and current evidence indicates they do not penetrate healthy skin when used as directed in topical sunscreen products.
Can moisturisers or make-up with SPF be regulated as sunscreens?
Yes. If a product’s primary purpose is sun protection or it exceeds certain SPF thresholds, it may be regulated as a therapeutic good and require ARTG listing. Lower-SPF cosmetics may be exempt, depending on how they are formulated and marketed.
What should I do if my sunscreen batch is recalled?
If your sunscreen’s batch number matches a TGA recall notice, stop using the product and follow the sponsor’s instructions for refund or replacement. Only affected batches need to be returned; other batches of the same product may remain compliant.
What does “broad-spectrum” protection actually mean?
Broad-spectrum sunscreens provide protection against both UVB rays, which cause sunburn, and UVA rays, which contribute to skin ageing and long-term damage. Broad-spectrum claims must be supported by validated testing under Australian standards.
What do water-resistant “2 hr” or “4 hr” claims mean?
These claims indicate that the sunscreen maintained its tested SPF after controlled water-immersion testing for the stated time. In real-world conditions, factors like swimming, sweating, and towel-drying can reduce protection sooner, so regular reapplication is still essential.
Is “reef-safe” a regulated sunscreen term in Australia?
No. “Reef-safe” is not an official or regulated term under Australian sunscreen regulations. The TGA assesses sunscreens for human safety and SPF performance, not environmental impact. Consumers concerned about reef effects should first confirm TGA compliance, then review ingredient preferences.
Bottom line: Natural/mineral sunscreens are not singled out by the recall; compliance and performance are what count. Choose TGA-listed products you’ll apply generously and reapply—then enjoy the sun, sensibly.
About this article
- Sunscreens regulated by the TGA — Australian Government (Sep 2025)
- Sunscreen SPF testing - information for consumers — Australian Government (Sep 2025)
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Notes:Article published