A contract manufacturer’s view of why the move “beyond UV filters” adds a testing cycle to a sun care project — and how to plan around it.
Written & researched by Lai Gek Yan, Contributor, ORIZI Group · Technical input by ORIZI Group R&D Team · Fact-checked by Creaton Poh · Published by ORIZI Group · Last reviewed August 2026
Disclosure: This article is published by ORIZI Group and may refer to our own manufacturing experience, services and capabilities. External factual claims are supported by cited sources.
Quick answer: why does changing a sunscreen formula mean testing the SPF again?
Sun Protection Factor (SPF) is a measured property of the finished product, not of its UV filter combination, so a formula change can move the number even when the filters and their percentages stay identical. The filters only work if the product forms an even film on skin, and pigments, emollients, film formers, thickeners and the emulsifier system all change how that film spreads and holds. Malaysia’s regulator requires the labelled SPF to be substantiated by testing, which is why we treat a late formula change as a new test, not an amendment.
Key takeaways
- SPF belongs to the finished product. Two batches with the same filter percentages can test differently if the vehicle around those filters has changed.
- The additions that make a sunscreen “more than UV protection” — tints and iron oxides for visible light, antioxidants, post-exposure actives, water-resistant film formers — are also the additions most likely to disturb the UV film. They belong in the formula before the SPF panel is booked.
- In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) requires an SPF value to be substantiated by testing to standards such as ISO 24444, and prohibits “sunblock”, “waterproof”, “sweatproof”, 100 % protection and whole-day protection claims.
- The 2025 Australian SPF controversy — 16 of 20 tested SPF 50/50+ products failing their label claim, followed by a regulator review of the affected products completed in December 2025 — was an evidence-chain failure as much as a formulation one.
- The most expensive change we see on a sun care project is a small one made late: a different pigment shade, a switched emollient, a new pump. Each of those can reopen the test.
Scope and definitions
This article covers leave-on sun care developed under an OEM (Original Equipment Manufacturer) or ODM (Original Design Manufacturer) arrangement for the Malaysian and wider ASEAN market. It is written from a manufacturing and development perspective; it is not medical advice and it does not evaluate any specific brand’s product.
Three terms are used throughout. SPF is the ratio of the ultraviolet energy needed to produce a minimal erythema (sunburn) on protected skin versus unprotected skin, measured on a finished product at a defined application thickness. UVA-PF is the equivalent protection factor for the longer UVA wavelengths, which drive pigmentation and photo-ageing rather than immediate burning. Visible light, particularly the high-energy visible (HEV) band, sits outside the ultraviolet range entirely and is not measured by either number.
The regulatory scope in Malaysia is narrower than people assume. NPRA’s sunscreen guideline applies “only to sunscreen products whose primary function is UV protection” and expressly does not apply to products making secondary UV claims, such as moisturisers or colour cosmetics carrying an SPF (Guidelines for Control of Cosmetic Products in Malaysia, Annex I Part 9(i)).
Why does the SPF number belong to the finished product?
Because SPF is measured on skin or on a roughened plate, and what is measured is a film — not a chemical inventory. The test applies the product at a controlled thickness and then measures how much ultraviolet energy gets through. If the product spreads unevenly, sinks into skin texture, or pulls away from the surface as it dries, the thin spots dominate the result. Two products with identical filter loadings can therefore land several SPF points apart.
The in-vivo reference method, ISO 24444, is one of the standards NPRA lists as acceptable for substantiating an SPF value, alongside AS/NZS 2604:2012 and the United States Food and Drug Administration’s 2011 Final Rule. In-vitro methods have advanced since: ISO 23675:2024 introduced a double-plate in-vitro SPF method intended to improve reproducibility and reduce reliance on human panels, and ISO 24443 remains the widely used in-vitro route to UVA-PF. What none of them do is let you calculate a finished-product SPF from a filter list.
This is the practical reason a development team asks so many questions about things that look cosmetic. The emollient blend changes the refractive behaviour and the spreading of the film. A thickener changes how the film settles in the minutes after application. A pigment adds particles that the film has to carry. None of these are filters, and all of them can move the number.
What do brands ask us to add on top of the filters?
Almost every sun care brief we see now asks for something beyond ultraviolet protection. That is a reasonable response to the science — UV filters address the ultraviolet band, and the ultraviolet band is not the only part of sunlight that affects skin. Research on visible light has shown it can induce pigmentation that is darker and more sustained than the pigmentation induced by UVA1 in deeper skin phototypes, which is exactly the population most of our regional customers formulate for (Zhou et al., “Guide to tinted sunscreens in skin of color”, International Journal of Dermatology, 2024). It is also, in formulation terms, the part of the brief most likely to reopen testing.
| What the brief asks for | Why brands ask | What it changes in development | Testing consequence |
|---|---|---|---|
| Tint / iron oxides | Visible-light protection, no white cast on deeper skin tones | Adds pigment loading and dispersion work; shade must survive the emulsion and the fill | New SPF panel per shade in most cases; shade changes are formula changes |
| Antioxidants (e.g. tocopherol, ascorbyl derivatives) | Address oxidative stress that filters do not absorb | Stability and colour drift become the constraint; some require pH or packaging changes | Full stability re-run; SPF re-test if the vehicle shifts to accommodate them |
| Post-exposure / recovery actives | “After-sun” and repair positioning within one product | Often better as a companion SKU than inside the sunscreen — the filter system is already crowded | Depends: as a separate product, no SPF test at all |
| Water resistance | Outdoor, sport and tropical-climate use | Film formers change the drying profile and the skin feel | Separate water-resistance testing on top of the SPF test |
| Lighter texture / “invisible” finish | Daily wear and compliance — people reapply what they like wearing | The hardest one. Reducing the film usually costs measured protection | Iterative: several SPF checks before the texture is locked |
The last row is the one worth dwelling on. A sunscreen that is unpleasant to wear gets applied thinly and infrequently, and thin application is the single largest gap between a label number and real-world protection. So texture work is not vanity. It is just expensive, because every meaningful step towards a lighter film has to be checked against the number the label will carry.
What do the rules in Malaysia actually require?
They require evidence and they restrict language. NPRA’s guideline sets out an SPF classification scale, requires substantiation by testing, mandates a warning statement, and lists the claims that cannot be made regardless of how the product performs.
| Requirement | What the guideline says |
|---|---|
| Minimum for a UV claim | No UV protection claim if SPF is below 6 |
| Classification | Low (SPF 6 to under 15), Medium (15 to under 30), High (30 to under 50), Very High (50 and above); above 50 may only be labelled “SPF 50+” |
| Substantiation | SPF value must be substantiated by testing — ISO 24444, AS/NZS 2604:2012 or the FDA 2011 Final Rule are listed as acceptable |
| Prohibited claims | 100 % protection, “sunblock”, “waterproof”, “sweatproof”, and any implication that reapplication is unnecessary |
| Mandatory warning | “Do not stay too long in the sun, even while using a sunscreen product” |
| UV filters | Only filters permitted under Annex VII of the ASEAN Cosmetic Directive, within their stated concentration limits |
Two points regularly surprise brand owners. The first is that an SPF of 130 can only ever be labelled SPF 50+. The second is that a moisturiser or foundation carrying an SPF sits outside this particular guideline, because its primary function is not UV protection — which does not mean the claim is unregulated, only that a different set of expectations applies to it.
Elsewhere the numeric bar is set differently. The European Union’s Commission Recommendation 2006/647/EC asks that a UVA claim be supported by a UVA protection factor of at least one third of the labelled SPF and a critical wavelength of at least 370 nm (EUR-Lex, Recommendation 2006/647/EC). If a product is destined for both markets, that ratio is the tighter constraint and should be designed in from the start rather than discovered at the end.
What we have learned sequencing sun care projects
Based on ORIZI Group’s manufacturing experience, sun care is the category where the order of work matters most. In a normal skincare project a brand can adjust texture and fragrance late without disturbing the substantiation. In sun care, the same late adjustment can invalidate the one number the whole product is sold on. So we treat SPF testing as a stage gate rather than a step, and we ask brands to close four decisions before it opens:
- The full ingredient list, including the “beyond UV” additions. Antioxidants and tints added after a passing test are not free additions; they are a new formula.
- Every shade, if the product is tinted. Shades usually test separately, and a shade range decided late multiplies the testing cost rather than adding to it.
- The claim set. Water resistance, UVA wording and any export market’s requirements determine which tests are booked, not the other way round.
- The primary pack. Pump, tube or bottle affects dose delivery, film thickness in real use and stability.
The limitation of this framework is honest: it makes the front of a project slower and more demanding. Brands that want a sample in hand quickly find it frustrating. What it buys is that the number on the finished carton is the number that was tested, on the formula that was filled — which is the part that becomes very difficult to fix afterwards. Where a brand is still deciding on format and positioning, we usually suggest working through the groundwork in our guide to starting a sunscreen brand in Malaysia before locking a development brief, and our OEM sunscreen manufacturing page sets out the formats and compliance scope we work within.
Where sun care projects commonly go wrong
- Treating the filter list as the product. Two manufacturers quoting the same filters are not quoting the same protection.
- Testing early, changing later. A passing SPF result attaches to one formula. Every subsequent change asks the question again.
- Confusing UVA coverage with a UVA number. Containing UVA filters is not the same as meeting a defined UVA-PF ratio, and only one of those is a claim.
- Assuming visible-light protection follows from a high SPF. It does not. Visible-light performance comes largely from pigments, and it is a separate design decision.
- Underestimating stability. Sun care is a demanding system to hold together in a tropical supply chain, and colour drift in a tinted product shows up first.
The same discipline applies whenever a claim carries evidence rather than opinion — we wrote about the parallel case in what a “for sensitive skin” brief actually changes in the lab.
Frequently asked questions
Can a manufacturer estimate SPF without testing?
A development team can model an expected range from the filter system and prior formulations, and we do this to decide whether a formula is worth testing at all. That estimate cannot be labelled. Malaysia’s guideline requires the SPF value to be substantiated by testing on the finished product, so the model informs development and the test produces the claim.
Does adding an antioxidant raise the SPF?
Not reliably, and it should not be assumed. Some ingredients do measurably support a filter system, but the effect depends on the whole formula and is only known once the finished product is tested. An antioxidant is best justified by what it is for — oxidative stress that filters do not absorb — rather than as a way to reach a higher number.
Why do tinted sunscreens usually need testing per shade?
Because a shade change is a change to the particle load the film has to carry, and that can alter both the film and the measured protection. Pigments also matter in their own right: iron oxides are the main practical route to visible-light protection, which is why tinted formats are discussed so often for deeper skin tones rather than being purely a cosmetic choice.
How long does a sun care development project take compared with ordinary skincare?
Longer, and the difference sits almost entirely in substantiation. Formulation iterations run at a similar pace to other leave-on skincare; the additional time comes from SPF and any UVA or water-resistance testing, external laboratory scheduling, and the possibility of a re-test if the formula moves. Treat testing as a booked slot with a lead time, not as a formality at the end.
Is SPF 50+ meaningfully better than SPF 30?
The additional filtration between those levels is real but incremental, and in practice application thickness and reapplication matter more than the gap between the two numbers. That is the argument for spending development effort on wearability: a product someone applies generously and reapplies outperforms a higher-rated product used sparingly.
Sources and references
- NPRA, Guidelines for Control of Cosmetic Products in Malaysia, Annex I Part 9(i) — Guideline for Sunscreen Product (scope, SPF classification, substantiation, prohibited claims, mandatory warning).
- European Commission Recommendation 2006/647/EC on the efficacy of sunscreen products and the claims made relating thereto (UVA-PF ratio, critical wavelength, prohibited claims).
- ASEAN Cosmetic Directive, Annex VII — List of permitted UV filters (release of 12 December 2025).
- CHOICE (Australia), SPF testing of 20 sunscreens, June 2025, and the Therapeutic Goods Administration’s consumer information on sunscreen SPF testing, which records the completion of its review of the affected sunscreens in December 2025.
- Zhou et al., “Guide to tinted sunscreens in skin of color”, International Journal of Dermatology, 2024, and a randomised comparison of tinted and untinted sunscreen in melasma patients (visible-light pigmentation and iron oxides).
- ISO 24444 (in-vivo SPF), ISO 24443 (in-vitro UVA-PF) and ISO 23675:2024 (in-vitro SPF, double-plate method) — sun protection test method standards referenced above.
Source / inspired by: this article was prompted by Azelis Personal Care’s inspiration material on modern sun care moving beyond UV filters alone — see the Azelis Personal Care inspiration hub and its sun care and self-tan overview. The analysis, regulatory references and manufacturing perspective here are our own.
Further reading: a market-side view of the same trend, written for brand owners evaluating suppliers, is published on OEM Hallmark as Sun Care Beyond UV Filters: What Brands Are Really Buying.
Update history
13 August 2026 — first published.
Talk it through with us
If you are weighing what to add to a sun care formula and what it will cost you in testing, we are happy to walk through the sequence before you commit to a brief. You can see the scope we work within on our OEM sunscreen manufacturing page, or reach the team through ORIZI Group contact. No obligation — we would rather have the difficult conversation early than re-test a formula late.
