Dual-method SPF validation isn’t the exception anymore - it's the baseline (especially if you work with a manufacturer)

Over the past few weeks, Australia’s sunscreen category has faced an uncomfortable stress-test. Consumer group CHOICE reported that 16 of 20 products it commissioned for testing didn’t meet their labelled SPF; shortly after, Ultra Violette voluntarily removed Lean Screen SPF50+ from sale, disclosing that fresh, independent testing produced a wide spread of results across multiple labs. The TGA has since reiterated that variability in the current in-vivo (on-skin) SPF method is a known issue and is reviewing the evidence it has received. Several other brands have temporarily paused specific SKUs while additional tests run.

This isn’t an ordinary PR dust-up. It’s a manufacturing and governance moment - especially for founder-led brands who work with contract manufacturers (CMOs). The message is simple: if you outsource the product, you still own the science, and single-method “passes” no longer satisfy your stakeholders.

Why the current baseline is under pressure

In-vivo testing (ISO 24444) (the long-standing, human-panel method that underpins label claims ) has strengths. It mimics real-world use and a well-documented weakness: noise. Human skin responses vary, panel composition matters, and subtle execution differences between labs can shift outcomes. The TGA has publicly acknowledged this variability while it reviews data and next steps.

In parallel, the standards world is moving: ISO 23675:2024 formalises an in-vitro pathway for determining SPF on an analytical substrate - faster, more repeatable, and powerful as a monitoring tool alongside in-vivo. It doesn’t replace on-skin efficacy requirements in Australia today, but it gives brands and manufacturers a second lens on formula and process consistency.

Dual-method validation, in plain English

• In-vivo (on-skin): Required baseline for therapeutic sunscreens in Australia. It answers the clinical question (does this protect people in use?) but is inherently variable.

• In-vitro (instrumental): Measures UV transmission through a standardised film. It’s faster, cheaper and highly repeatable, so it’s ideal for surveillance across lots, and for catching formulation or process drift early.

  
  

Together, the two methods reduce risk: in-vivo establishes claim-level efficacy; in-vitro tracks lot-to-lot consistency so you see smoke before there’s fire.

The trust gap your customers (and stockists) now see

The sequence of events has trained the market to expect more than a single certificate:

• Independent confirmation and transparency. When Ultra Violette disclosed the spread of results (SPF 4 → 64 across eight tests) and withdrew the SKU, it set a new reference point for data-led decision-making - even if the path there was messy.

• Precautionary pauses while testing runs. Multiple brands (including Aspect and Aspect Dr) have temporarily halted sales of particular mineral sunscreens pending fresh tests - a sign of stronger post-market control and an acknowledgment that SPF is a distribution, not a fixed number.

• Regulator posture. The TGA continues to investigate, explicitly noting the variability in in-vivo results and signalling further updates. Expect closer scrutiny of methods, surveillance and claims governance.

  
  

What this means if you work with a manufacturer

If you partner with a CMO, the bar has moved from “do we have a pass?” to “do we have a system?”. In practice, brands are increasingly asking their manufacturing partners for:

• A two-track testing architecture (in-vivo for claim; in-vitro for surveillance) across development, validation and the product’s commercial life.

• Evidence of robustness across labs (ring-testing) and across lots (not just a pilot batch). That expectation has been normalised by recent disclosures and reporting.

• Post-market vigilance that looks beyond headline SPF to signals that correlate with drift (for example, viscosity/rheology bands and dispersion stability for mineral filters) paired with timely re-testing when those signals move. (This is industry best practice in quality systems, reinforced by how quickly lot-level issues can surface publicly.)

• Proportionate consumer communication (clear status updates, refunds or exchanges where appropriate, and dates for the next data point) delivered in cooperation with retailers if a pause is warranted. Recent retailer responses show how quickly shelves can change when confidence wobbles.

  
  

The point isn’t to overwhelm your manufacturer with paperwork; it’s to demonstrate a repeatable, inspectable process that can withstand scrutiny from consumers, media and regulators when questions arise.

A note on “public interest” and tone

Given the community concern about sunscreen efficacy (and the TGA’s active review) brands communicating about their testing approach, surveillance, and decisions are participating in a legitimate public-interest and industry conversation.

The most credible pieces separate verifiable facts (with dates and sources) from clearly labelled interpretation, and avoid speculating about causes until data supports it.

Where to from here

For founder-led brands that outsource production, the way forward is surprisingly straightforward:

• Treat SPF like a clinical-grade claim wrapped in consumer packaging.

• Build (and disclose) a dual-method validation and surveillance story you can stand behind.

• Align your manufacturer, retailers and comms so that when variability shows up—as it sometimes will—you move quickly, transparently and proportionately.

Done well, this moment becomes an opportunity to increase trust rather than lose it.

NB: Facts and links current as at 1 September 2025 (AEST). This article is general information for industry professionals. If you believe any detail is inaccurate, please get in touch so we can review and, if needed, correct promptly.