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Titanium dioxide mineral sunscreen OEM/ODM manufacturing
Titanium Dioxide Mineral Sunscreen · OEM/ODM
Titanium dioxide (TiO2) is a white mineral powder, insoluble in water and organic solvents, with two roles in cosmetics: UV filter and white colorant (CI 77891). As a UV filter, Annex VII of the ASEAN Cosmetic Directive permits the regular form (Ref 27) and the nano form (Ref 27a), up to 25%, and when both forms are used the total may not exceed 25%. Compared with zinc oxide, titanium dioxide gives better UVB protection, while zinc oxide absorbs broadly across both UVA and UVB (Schneider and Lim, 2019) — which is why the two are often combined. In most human and animal studies, titanium dioxide nanoparticles did not penetrate beyond the outer layers of the stratum corneum, even on compromised skin (review by Dreno et al., 2019); the main concern is inhalation, so the nano form may not be used in products that could be inhaled into the lungs. The second specific issue is photocatalytic activity: under UV, uncoated particles generate more reactive oxygen species, so a surface-coated grade is chosen. This page differs from the general sunscreen page because titanium dioxide is the named filter: the formula is built around the particle grade and coating, dispersion, white cast on darker skin and the nano dossier. SPF and UVA values are labeled only once they have been measured on the finished product. Butter-C offers turnkey OEM/ODM manufacturing, from formula development and coordination of sun protection testing to labeled finished goods and the notification dossier.
Formula base
Titanium dioxide as the named filter, starting with the right particle grade
The filter determines UV filtering; the particle grade, coating, oil base and dispersant determine whether the cream layer is even, stable and how white it looks. Butter-C checks the current Annex VII (version 2025-2, 12 December 2025) and Annex III (2026-1) when building the formula.
Titanium Dioxide
CAS 13463-67-7, 1317-70-0, 1317-80-2. Annex VII Ref 27 (titanium dioxide) and Ref 27a ("Titanium dioxide (nano)"): maximum 25%; footnote (4): when both forms are used, the sum may not exceed 25%. Ref 27 refers powders containing 1% or more of particles with an aerodynamic diameter ≤ 10 µm to Annex III Ref 338; Ref 27a states "Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation". Particle size, crystal form, coating and whether the material is nano are confirmed from the technical data sheet (TDS) and the certificate of analysis (COA) of each lot.
Surface coating
In an in vitro test with anatase-rich nanoparticles, uncoated particles degraded the dye methylene blue by 64%, silica-coated particles by 55–59% and alumina–silica-coated particles by 22–24%; the alumina–silica-coated particles were also less toxic to cultured keratinocytes, although the level of reactive oxygen species in the cells did not differ between coating types (Katsanou et al., 2026). Butter-C therefore uses a coated grade, and the coating agent must also appear in the ingredient list.
Oil base and emulsifier
Esters such as C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride and Dicaprylyl Carbonate wet and carry the powder; a water-in-oil emulsion with Polyglyceryl-2 Dipolyhydroxystearate and an electrolyte in the water phase. Choose a hydrophobically coated grade for the oil phase or a hydrophilically coated grade for the water phase, with a dispersant and enough homogenization to prevent agglomeration (manufacturing practice).
Combining with zinc oxide
Titanium dioxide gives better UVB protection, zinc oxide extends into UVA (Schneider and Lim, 2019). Each substance is counted under its own Annex VII entry: titanium dioxide Ref 27/27a, zinc oxide Ref A29/A29a, and for each substance the regular plus nano forms may not exceed 25%. Zinc oxide data are covered on the zinc oxide sunscreen page.
Iron oxides (tinted version)
Iron Oxides (CI 77491, 77492, 77499) are Annex IV colorants, not UV filters. In a study in 12 volunteers comparing four products, the product containing 11% titanium dioxide, 1% iron oxides and antioxidants gave the highest and most consistent protection against visible light plus UVA1; the authors noted that the tinted products protected better than the untinted ones (Ezekwe et al., 2024) — a result of the whole formula.
Key technical points
Four issues specific to a titanium dioxide sunscreen
The four items below are settled on the sample before it goes for SPF testing — changing the powder source, coating, dispersant or oil ratio after testing can change the result.
Photocatalysis
Under UV, titanium dioxide can generate reactive oxygen species; the Katsanou (2026) data were obtained on anatase-rich particles, whereas Ref 27a only allows nano titanium dioxide in rutile form or rutile with up to 5% anatase, with photocatalytic activity ≤ 10% compared with the corresponding non-coated or non-doped reference. The supplier's dossier must include these data.
Oil base and penetration
With microfine titanium dioxide of about 20 nm, particles penetrated deeper into human skin from an oily dispersion than from an aqueous one; an oil-in-water emulsion with the powder in the water phase showed no particle penetration but had poor storage stability; encapsulation in liposomes made the particles go deeper (Bennat and Muller-Goymann, 2000). Butter-C balances dispersion, emulsion stability and the choice of phase for the powder, and does not use liposomes to carry the powder.
White cast and darker skin
Our titanium dioxide article notes that people with darker skin see white cast more easily and that tinted products are easier to use; the review by Schneider and Lim (2019) states that nano-sized particles are less visible after application. Butter-C scores white cast on several skin tones to balance the titanium dioxide level, particle grade and iron oxides against the target value.
Nanoparticles and inhalation
If the nano form is used, the material must meet the Ref 27a criteria: purity ≥ 99%; rutile form, or rutile with up to 5% anatase, crystalline, appearing as clusters of spherical, needle or lanceolate shapes; median particle size by number ≥ 30 nm; aspect ratio 1–4.5 and volume specific surface area ≤ 460 m²/cm³; coating materials demonstrated to be safe and not to affect the particle properties; nanoparticles photostable in the final formulation — the dossier is kept in the PIF. This product is not made as a spray or a powder.
Three formulation directions
Three formats of titanium dioxide sunscreen
Mineral titanium dioxide – zinc oxide cream
Mineral filters only: titanium dioxide covers the UVB side, zinc oxide contributes UVA. Aimed at people who want to avoid organic filters; the challenges are white cast and a dry feel. "Broad spectrum" is labeled only once UVA has been measured on the finished product.
Tinted titanium dioxide cream
Iron oxides are added so the cream matches skin tone and shows less white cast; according to Ezekwe (2024), visible light plus UVA1 induces hyperpigmentation, particularly in darker skin types, and the tinted products protected better against this range. Each shade is a separate formula and a separate test.
Hybrid titanium dioxide – organic UVA filters
Titanium dioxide combined with broad-spectrum or UVA organic filters from Annex VII (for example Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ref 25, or Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ref 28) to lower the powder level and white cast. Each filter within its own limit; a photostability test on the whole formula; a hybrid version is not labeled "mineral filters only".
Packaging is planned with the formula
Multilayer tubes or pump bottles; checks for powder settling, oil separation at the tube neck and plastic compatibility. No sprays or loose powders: Ref 27a and Annex III Ref 338 (point c) exclude applications that may lead to inhalation into the lungs.
Parameters we monitor
What our R&D team measures on every sample
Below are the parameters Butter-C monitors during formula development and scale-up to production. Specific limits are agreed with you on the approved sample and then written into the product's in-house specification.
- SPF
- The labeled value is measured on people under ISO 24444:2019 at a laboratory whose ISO/IEC 17025 accreditation covers this method; in vitro screening results are used only during formula development.
- UVA protection
- Measured under ISO 24443:2021 (UVA protection factor, critical wavelength); the UVA symbol on the label follows the rules of the target market, since the ASEAN sunscreen labeling guideline does not set a specific symbol.
- Water resistance
- Tested under ISO 16217:2020 when the label says "water resistant".
- Titanium dioxide content
- Per formula, with regular plus nano forms not exceeding 25% in total; COA of the powder for each lot (purity, crystal form, particle size, coating, photocatalytic activity for the nano form) and a check on the finished product by the testing laboratory's method.
- White cast, color
- White cast scoring on several skin tones; for the tinted version, each lot is color-matched to the reference sample.
- Dispersion and stability
- Centrifugation, freeze–thaw cycling, storage at 40 °C; monitoring for powder settling, oil separation, lumps and color change; agglomerates checked under the microscope.
- Photostability
- UV absorbance of the formula before and after UV exposure — for the nano form (Ref 27a requires nanoparticles to be photostable in the final formulation) and for the hybrid version.
- Microbiology & preservative challenge
- Tested at a GLP / ISO 17025-accredited laboratory; preservative efficacy test under ISO 11930.
Claims
Writing claims within the cosmetic scope
Every number on a sunscreen label must be backed by a test report on the finished product itself in the Product Information File. Wording follows the ASEAN sunscreen labeling guideline (Appendix X, Revision 02, 18 November 2025); whether this guideline is mandatory needs regulatory confirmation, and Butter-C applies it as a minimum. Butter-C reviews the wording on the label and in marketing materials when preparing the notification dossier.
Helps protect skin against UVB; "broad spectrum" and "UVA protection" only once UVA has been measured on the finished product
Instead of: blocks UV completely, total sun protection, "sunblock".
SPF and PA according to the test result; SPF above 50 labeled "SPF 50+"
Instead of: values calculated from the ingredient list, SPF 80 or SPF 100.
Titanium dioxide mineral UV filter (mineral-only version)
Instead of: "chemical-free" (titanium dioxide is also a chemical), "physical sunscreen that only reflects UV"; a hybrid version is not labeled "mineral filters only".
Directions to apply enough and reapply after sweating, swimming or toweling
Instead of: all-day protection, no need to reapply.
Mandatory label warning
"Do not stay too long in the sun, even while using a sunscreen product" (Annex VII, for primary sunscreen products) — printed in the equivalent Vietnamese, with the translation approved by regulatory affairs.
Try on a small area of skin first; pregnant women should ask a doctor if in doubt
Instead of: non-irritating, safe for every skin, completely safe for children and pregnant women. The product is not positioned for children: sunscreens for children need a separate safety assessment for the age group, and for infants a pediatrician should be consulted.
Water resistant; helps protect against visible light (tinted version) — only once tested on the finished product
Instead of: won't wash off, fully waterproof, prevents skin cancer, drug-like claims about melasma or tanning.
Manufacturing specifications
Current capabilities
- Texture
- Sunscreen cream or lotion, untinted or tinted.
- Pack formats
- Tubes, pump bottles. No sprays or powders containing titanium dioxide. Volume agreed when packaging is selected.
- Minimum order quantity
- Agreed per order — depends on the formula direction, the number of shades and the pack format chosen.
- Testing
- Quality parameters tested at a GLP / ISO 17025-accredited laboratory; SPF and UVA measured at a specialized testing facility.
- Dossier
- Product Information File (PIF) with SPF and UVA reports, the titanium dioxide COA (coating, crystal form) and the nanomaterial dossier when the nano form is used; notification dossier prepared by Butter-C.
- Packaging
- Label design with the mandatory sunscreen warning and reapplication directions; printing and packing run in parallel with formula work.
Suggested product concept
Tinted mineral titanium dioxide – zinc oxide sunscreen
A product concept to help you picture the possibilities, not a ready-made product for sale. The actual formula is developed to match your brand positioning and price range.
Coated titanium dioxide
The named filter, non-nano particles; the level is set by the SPF measured on the finished product and the white cast score, never above 25%.
Zinc oxide alongside
Contributes UVA in the mineral-only version; counted under the zinc oxide entry.
Iron oxides matched to skin tone
Makes the cream match the skin and reduces white cast; the number of shades is agreed with you.
40 ml tube
Water-in-oil emulsion, fragrance-free; the label carries the mandatory sunscreen warning and directions to apply enough and reapply.
Customization options
What you can specify
The same product type can serve very different customer groups depending on the brand. Tell us your requirements in the areas below and our team of pharmacists will develop a matching formula.
Target values
Desired SPF and UVA level — the final number follows the test result on the finished product.
Regular or nano particles
Nano shows less white cast but needs a dossier meeting all Ref 27a criteria; how "(nano)" is written in the ingredient list is confirmed by regulatory affairs.
Mineral-only or hybrid
Mineral-only (titanium dioxide, possibly with zinc oxide) for a "mineral filters only" story; hybrid for less white cast, with a photostability test.
Untinted or tinted
Untinted, one shade or several shades — each shade is a separate test.
Texture
Rich cream for dry skin or a thin, dry-touch lotion for oily skin.
Target market
Domestic only or export — the list of permitted filters, how the nano form is labeled and the UVA symbol differ from country to country.
Further reading
Related topics
Titanium dioxide in cosmetics
How it filters UV, photocatalysis, safety on skin and by inhalation, nano and powder conditions (in Vietnamese).
Facial sunscreen manufacturing
The three filter systems — organic, inorganic and hybrid — for sunscreens in general.
Zinc oxide sunscreen manufacturing
The other mineral filter, often combined with titanium dioxide.
SPF: what it means and how it is tested
ISO methods and the ASEAN sunscreen labeling guideline (in Vietnamese).
Iron oxides in cosmetics
Tinted sunscreens and the data on visible light (in Vietnamese).
How we work
From idea to finished batch
Eight steps and three milestones signed off by both sides: approved sample, notification number, finished batch. Step-by-step details →
Get started
Tell us about the product you plan to launch
Send us your product direction and expected volume. Our team will get back to you during business hours (Vietnam time, GMT+7).
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