Zinc oxide (ZnO) is used in cosmetics and personal-care products as a mineral UV filter, colourant, and skin-protectant ingredient. Its regulatory status depends not only on the country but also on the product’s intended use and claims.
A zinc oxide sunscreen may be regulated as a cosmetic in the European Union and ASEAN, as an over-the-counter drug in the United States, or as a special cosmetic requiring registration in China. Nano-sized materials, inhalable formats, SPF testing, product notification, and labelling can introduce additional requirements.
This guide compares the regulatory treatment of zinc oxide in the EU, United States, Japan, China, and ASEAN. Requirements change over time, so manufacturers should always confirm the latest official rules in every market before launch.
What Do Regulatory Standards for Zinc Oxide Cover?
Regulatory standards establish how zinc oxide may be used and what evidence a company must hold before placing a product on the market. Depending on the jurisdiction and product type, they may address:
- Maximum authorised concentration
- Permitted functions and product categories
- Nano and non-nano material specifications
- Restrictions on inhalable powders and sprays
- Ingredient and nanomaterial labelling
- Product notification, registration, or premarket approval
- SPF, UVA, and water-resistance testing
- Safety assessments and technical documentation
- Manufacturing, facility, and product-listing obligations
The same concentration limit should not be applied automatically across all uses. A limit for zinc oxide as a UV filter may differ from the requirements governing its use as a colourant or OTC skin protectant.
How Is Zinc Oxide Regulated in the European Union?
Cosmetic products in the EU are governed by Regulation (EC) No 1223/2009. Zinc oxide and specified nano forms are listed as permitted UV filters in Annex VI.
UV-Filter Concentration
Zinc oxide may be used as a UV filter at up to 25% in the finished cosmetic product. When nano and non-nano zinc oxide are used together, their combined concentration must not exceed 25%.
Authorised nano zinc oxide must meet the specifications listed in Annex VI, including requirements related to purity, crystalline structure, particle-size distribution, solubility, and permitted coatings.
Nano and Inhalation Restrictions
Nano zinc oxide is not permitted in applications that may expose the end user’s lungs through inhalation. This restriction is particularly relevant to aerosol sprays and loose-powder formats that can generate respirable particles.
The Scientific Committee on Consumer Safety concluded that specified nano forms may be used safely at up to 25% in dermally applied products. That conclusion should not be extended to every nano zinc oxide material or product format without confirming that it matches the authorised specifications.
Labelling and Documentation
Nanomaterials must be identified in the ingredient list by placing the word “nano” in brackets after the ingredient name, for example, Zinc Oxide (nano).
Before an EU cosmetic is marketed, the responsible person must ensure that it has:
- A Cosmetic Product Safety Report
- A Product Information File
- Good Manufacturing Practice documentation
- Substantiated product claims
- A compliant label
- Cosmetic Products Notification Portal notification
Sunscreen claims must be supported by suitable testing. The responsible person and safety assessor must determine which recognised methods and supporting evidence are appropriate for the product.
How Is Zinc Oxide Regulated in the United States?
The United States distinguishes between ordinary cosmetics, colour additives, OTC skin protectants, and OTC sunscreens. A single formulation may fall under different requirements depending on its intended use and claims.
Cosmetic Colourant
Zinc oxide is permanently listed under 21 CFR 73.2991 for use as a colour additive in cosmetics, including products applied around the eyes. It is exempt from batch certification but must comply with the regulation’s identity, purity, and use conditions.
A cosmetic containing zinc oxide as a colourant remains subject to general FDA cosmetic safety, labelling, facility-registration, and product-listing requirements where applicable.
OTC Skin Protectant
Under 21 CFR 347.10, zinc oxide may be used at 1% to 25% as an active ingredient in OTC skin-protectant drug products.
These products must comply with the applicable active-ingredient, indication, warning, direction, and Drug Facts labelling requirements. The skin-protectant provision should not be confused with the separate sunscreen monograph.
OTC Sunscreen
Sunscreens are regulated as OTC drugs in the United States. Zinc oxide is permitted as a sunscreen active ingredient under OTC Monograph M020 at concentrations of up to 25%, subject to the monograph’s conditions.
The finished sunscreen must comply with applicable requirements covering:
- SPF and broad-spectrum testing
- Water-resistance claims
- Drug Facts labelling
- Required warnings and directions
- Drug establishment registration and product listing
- Applicable drug-manufacturing requirements
The FDA added bemotrizinol to the OTC sunscreen monograph in June 2026, but this update did not remove zinc oxide as a permitted mineral active ingredient.
Nano Materials
The United States does not impose an EU-style horizontal requirement to place “nano” next to an ingredient name on cosmetic labels. However, manufacturers remain responsible for substantiating safety based on the material’s particle properties and intended exposure.
Sprayable or powdered products require particular attention because dermal safety evidence does not automatically address inhalation risk.
How Is Zinc Oxide Regulated in Japan?
Japan regulates cosmetics and quasi-drugs under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, commonly called the PMD Act.
The applicable pathway depends on the product, ingredients, claims, and whether the formula falls within an established cosmetic or quasi-drug framework. Sunscreen products are not automatically quasi-drugs solely because they make SPF claims.
Manufacturers and importers should confirm:
- Whether the product will be marketed as a cosmetic or quasi-drug
- Whether the ingredient and concentration comply with applicable standards
- Which SPF and UVA test methods support the proposed claims
- Whether local notification, approval, or marketing-authorisation obligations apply
- What particle-size and safety information is needed for a nano-grade material
Japan does not generally require the EU-style “nano” notation in cosmetic ingredient lists. Nevertheless, particle size, coatings, purity, and safety should be documented, particularly when a nanoscale material is used.
Because Japanese requirements depend heavily on product classification and claims, a locally qualified regulatory professional should confirm the pathway before commercialisation.
How Is Zinc Oxide Regulated in China?
China regulates cosmetics under the Cosmetic Supervision and Administration Regulation. Sunscreen is classified as a special cosmetic, which means the finished product generally requires registration rather than ordinary-cosmetic filing.
Permitted Use and Product Registration
Zinc oxide is listed as a permitted sunscreen agent under China’s cosmetic technical standards, subject to the applicable concentration and use conditions. Manufacturers should verify the current version of the Safety and Technical Standards for Cosmetics before finalising a formulation.
A sunscreen registration dossier may require information relating to:
- Formula and raw-material specifications
- Product safety assessment
- Manufacturing and quality control
- SPF, UVA, and water-resistance claims
- Product standards and test reports
- Chinese labelling
- Efficacy-claim substantiation
Nano Materials
Nanomaterials receive additional scrutiny under China’s cosmetic safety-assessment framework. The dossier may need to address particle characteristics, aggregation, coatings, exposure, toxicology, and intended use.
An approval in the EU or another region does not automatically establish compliance in China. The material and finished product must satisfy the NMPA requirements applicable at the time of registration.
How Is Zinc Oxide Regulated Across ASEAN?
The ASEAN Cosmetic Directive provides a harmonised foundation for cosmetic regulation across ASEAN member states. National authorities implement the framework locally, so notification processes and enforcement can still vary between countries.
The December 2025 version of ASEAN Annex VII lists both zinc oxide and specified nano zinc oxide as permitted UV filters at up to 25%. When both forms are used together, their combined concentration must not exceed this limit.
Both forms are restricted from applications that may expose the end user’s lungs through inhalation. Nano zinc oxide must also meet the characteristics specified in Annex VII.
Before market entry, the responsible company generally needs to:
- Notify the product in each target member state
- Appoint or operate through a locally responsible entity
- Maintain a Product Information File
- Follow the ASEAN Cosmetic Directive ingredient annexes
- Comply with national labelling requirements
- Substantiate sunscreen and other cosmetic claims
- Monitor country-specific implementation and updates
ASEAN harmonisation does not create a single notification valid in every member country. A separate local process is generally required for each market.
How Do the Main Regional Requirements Compare?
| Region | Product classification | UV-filter limit | Nano requirements | Inhalation considerations |
|---|---|---|---|---|
| EU | Cosmetic | Up to 25% | Authorised specifications and “nano” labelling | Not permitted where lung exposure may occur |
| United States | OTC drug for sunscreen | Up to 25% | No horizontal nano label; safety must be substantiated | Product-specific safety assessment required |
| Japan | Depends on product and claims | Confirm under applicable standards | No general EU-style nano label | Assessed according to product format and exposure |
| China | Special cosmetic for sunscreen | Confirm under current technical standards | Nano safety information may be required | Inhalation exposure requires specific assessment |
| ASEAN | Cosmetic | Up to 25% | Specified nano characteristics under Annex VII | Restricted where lung exposure may occur |
This table provides a high-level comparison. It should not replace a formula-specific review of the current legislation, annexes, standards, and administrative guidance in each market.
What Safety Issues Apply to Bulk and Nano Zinc Oxide?
Nano zinc oxide can reduce visible whitening while maintaining UV attenuation. Its smaller particle size does not mean that it is intended to penetrate more deeply into the skin. Available safety assessments indicate that authorised sunscreen-grade particles remain mainly on the skin’s surface and within the outermost layer.
Safety depends on more than nominal particle size. Manufacturers may need to document:
- Primary particle size and number-size distribution
- Aggregation and agglomeration
- Crystalline form and morphology
- Purity and impurities
- Surface coatings
- Solubility and zinc-ion release
- Photoreactivity
- Dermal and inhalation exposure
- Stability within the finished formula
A nano zinc oxide material that does not match an authorised specification may require a different regulatory assessment or may not be permitted for the intended use.
Why Is Inhalation Exposure Treated Differently?
Dermal safety findings cannot be applied automatically to the lungs. Fine airborne particles may produce a substantially different exposure profile from particles dispersed in a cream or lotion.
The EU and ASEAN expressly restrict zinc oxide UV filters in applications that may lead to lung exposure. In other markets, manufacturers must still evaluate whether sprays, aerosols, or powders generate respirable particles and whether the available toxicological evidence supports the intended use.
The term “spray” alone does not resolve the issue. Droplet size, drying behaviour, nozzle design, particle release, application distance, and foreseeable misuse can all affect inhalation exposure.
What Environmental Claims Require Additional Evidence?
Mineral sunscreen should not automatically be described as “reef-safe” or environmentally harmless. Zinc oxide can dissolve partly into zinc ions, and environmental behaviour depends on particle size, coatings, concentration, formulation, and exposure conditions.
Environmental claims should be reviewed against the advertising and claims rules in each market. Companies should avoid broad statements unless they hold evidence relevant to the finished formulation and intended environment.
Packaging design, controlled dispensing, protective clothing, and responsible application may also help reduce environmental release.
What Documentation Should Manufacturers Prepare?
A multi-market launch requires more than a certificate of analysis. The required package will vary, but commonly requested documentation includes:
| Documentation | Typical purpose |
|---|---|
| Technical Data Sheet | Describes material specifications and recommended handling |
| Safety Data Sheet | Communicates occupational and transport hazards |
| Certificate of Analysis | Confirms batch-specific test results |
| Particle-size data | Supports nano or non-nano classification |
| Morphology and crystalline-form data | Demonstrates conformity with authorised specifications |
| Coating information | Supports safety, compatibility, and regulatory review |
| Purity and impurity profile | Confirms compliance with ingredient standards |
| Stability and compatibility data | Supports use in the intended formulation |
| Safety evidence | Supports the raw-material and finished-product assessment |
Finished-product documentation may also include SPF, UVA, water-resistance, stability, preservative-efficacy, packaging-compatibility, and claim-substantiation studies.
Raw-material data cannot replace testing of the completed sunscreen.
How Can Manufacturers Plan a Multi-Region Launch?
A practical compliance strategy begins with the most restrictive requirements among the intended markets. Manufacturers should define the product format, claims, particle type, and target countries before finalising the formula.
The process should include:
- Confirm the product classification in each country.
- Check the current positive lists, concentration limits, and material specifications.
- Determine whether the zinc oxide is nano or non-nano under each applicable definition.
- Eliminate inhalable formats where the chosen grade is not permitted.
- Build a safety and technical dossier for the raw material.
- Test the finished product using accepted regional methods.
- Prepare compliant labels and claim support.
- Complete the required notification, registration, or listing.
- Monitor regulatory updates after launch.
When selecting zinc oxide cosmetics grade, manufacturers should compare more than price and nominal purity. Particle consistency, coatings, dispersibility, documentation, and regulatory suitability can materially affect development timelines.
For more detail on material selection, check out our blog explaining how nano zinc oxide is used. Manufacturers can also check out our blog on zinc oxide regulatory considerations in sunscreen for additional formulation context.
Our cosmetic and pharmaceutical-grade zinc oxide and nano zinc oxide pages provide further product-specific information for technical review.
What Is the Future of Zinc Oxide Regulation?
Regulators continue to refine nanomaterial definitions, safety methods, inhalation assessments, environmental evaluation, and sunscreen-performance testing. Full global harmonisation remains unlikely in the near term because regions classify sunscreen differently and maintain separate market-entry systems.
Manufacturers can prepare for future changes by maintaining complete particle-characterisation data, monitoring annex and monograph updates, and avoiding claims that extend beyond available evidence.
Developing one universal dossier can improve efficiency, but each market will still require a jurisdiction-specific gap assessment.
Conclusion
Zinc oxide is accepted as a UV filter in major cosmetics markets, but the applicable concentration, product classification, nano specifications, testing, labelling, and approval pathway vary by jurisdiction. We recommend confirming these requirements before the formulation is locked and treating inhalation exposure as a separate safety issue from dermal use. At Glochem, we support manufacturers evaluating regional requirements and sourcing documented materials from an experienced zinc oxide manufacturer while recognising that final regulatory responsibility rests with the product’s responsible company and qualified advisers.
FAQ
Is zinc oxide permitted in sunscreen worldwide?
Zinc oxide is permitted in many major markets, but the concentration limits, material specifications, product classification, and approval process differ. Compliance in one region does not establish compliance elsewhere.
Is 25% the global maximum for zinc oxide sunscreen?
A 25% limit applies in several major frameworks, including the EU and ASEAN, as well as the U.S. OTC sunscreen monograph. Manufacturers should still verify the current limit and conditions in every target country.
Must nano zinc oxide appear on the label?
The EU requires nanomaterials to be identified using the ingredient name followed by “nano” in brackets. Other regions may instead require nano information in the technical or registration dossier without using the same label format.
Can nano zinc oxide be used in sunscreen sprays?
The EU and ASEAN prohibit uses that may expose the end user’s lungs through inhalation. Other markets require a format-specific safety assessment. Dermal approval does not establish inhalation safety.
Does a raw-material certificate prove sunscreen compliance?
No. Raw-material documents support ingredient assessment, but the finished sunscreen still requires appropriate safety, stability, performance, labelling, and market-entry work.
Is zinc oxide regulated in the same way as titanium dioxide?
No. Although both are mineral UV filters, they have separate entries, material specifications, safety opinions, and use conditions. Each ingredient must be assessed independently.
References
- European Commission. CosIng Annex VI: List of UV Filters Allowed in Cosmetic Products.
- European Commission Scientific Committee on Consumer Safety. Opinion on Zinc Oxide in Nano Form.
- Electronic Code of Federal Regulations. 21 CFR 347.10: Skin-Protectant Active Ingredients.
- U.S. Food and Drug Administration. FDA Expands Sunscreen Options for the First Time in 20 Years.
- ASEAN. Annex VII: List of UV Filters Which Cosmetic Products May Contain, Version 2025-2.
