Is Zinc Oxide safe in cosmetics?
Zinc Oxide has a safety rating of "EXCELLENT" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Zinc Oxide
Also known as: ZnO, Oxozinc, Zinc, oxo-, Zinc oxide (ZnO), Akro-zinc bar 85 (+14 more)
INCI: ZINC OXIDE
Zinc Oxide (CAS 1314-13-2) is a cosmetic active ingredient functioning as Broad-spectrum inorganic UV filter (UVA + UVB); reflects, scatters, and absorbs. NOAEL 0.166 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 25%; GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
View industrial chemical safety profile for CAS 1314-13-2 →
Auto-generated CPSR Part A draft with source citations
Function
Broad-spectrum inorganic UV filter (UVA + UVB); reflects, scatters, and absorbs radiation; surface coating type determines photocatalytic safety; also used as skin-conditioning and astringent agent
Safety Rating
EXCELLENT
Regulatory Status
EU EU Status
restricted
EU Max Conc.
25%
US US Status
permitted
US Notes
FDA GRASE under OTC sunscreen monograph at up to 25%; one of only two GRASE UV filter actives. Nano forms (20–100 nm) permitted; no nano-specific labeling or spray restriction in the US. Powder formats require additional safety data before GRASE confirmation.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Zinc Oxide.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Zinc Oxide. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 45 mg/kg bw/day | oral | swine | Short Term Toxicity | COSMOS DB |
| NOAEL | 99 mg/kg bw/day | oral | sheep | Short Term Toxicity | COSMOS DB |
| NOAEL | 100 mg/kg bw/day | oral | swine | Short Term Toxicity | COSMOS DB |
| NOAEL | 149 mg/kg bw/day | oral | cattle | Special Toxicology Study | COSMOS DB |
| NOAEL | 164 mg/kg bw/day | oral | swine | Short Term Toxicity | COSMOS DB |
| NOAEL | 172 mg/kg bw/day | oral | rat | Chronic | COSMOS DB |
| NOAEL | =42.5 mg/kg | oral | rabbit | developmental toxicity | SCCNFP Opinion |
| NOAEL | =42.5 mg/kg | oral | rabbit | developmental toxicity | SCCNFP Opinion |
| NOAEL | =42.5 mg/kg | oral | rabbit | developmental toxicity | SCCNFP Opinion |
| NOAEL | =42.5 mg/kg | oral | rabbit | developmental toxicity | SCCNFP Opinion |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
WARNING
Pictograms
EnviroAqua
Hazard Statements
Very toxic to aquatic life with long lasting effects
Short-term Exposure Effects
May cause mechanical irritation to the eyes and respiratory tract. The fume is irritating to the respiratory tract. Inhalation of fumes may cause metal fume fever. See Notes.
Routes of Exposure
The substance can be absorbed into the body by inhalation of fume.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Zinc Oxide across SCCS product categories, with measured dermal absorption where available.
Sensitization Profile
Contact sensitization data for Zinc Oxide based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
metal
EU Allergen Listed
no
Patch Test Positive Rate
0.1%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis
Source: ESSCA 2019/20; NACDG 2021-22
Dermal Penetration Profile
Skin absorption and penetration characteristics of Zinc Oxide, relevant to systemic exposure and MoS calculations.
Absorption %
0.01-0.1%
Penetration Level
surface
Penetration Depth
surface only
Molecular Weight
81.4 Da
Log P
n/a
Systemic Absorption
minimal
Topical Bioavailability
0.01%
Safety Margin Factor
none
Source: SCCS Opinion
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LOAEL | =125 mg/kg-day | Rat | oral | subchronic | ECHA |
| LOAEL | =125 mg/kg-day | Rat | oral | subchronic | ECHA |
| NOAEC | =7.5 mg/m3 | Rat | inhalation | - | ECHA |
| NOAEL | =200 mg/kg-day | Rat | oral | - | ECHA |
| NOAEL | =200 mg/kg-day | Rat | oral | - | ECHA |
| NOAEL | =400 mg/kg-day | Rat | oral | - | ECHA |
| NOAEL | =31.25 mg/kg-day | Rat | oral | subchronic | ECHA |
| LOAEL | =125 mg/kg-day | Rat | oral | subchronic | ECHA |
| LOAEL | =125 mg/kg-day | Rat | oral | subchronic | ECHA |
| NOAEC | =7.5 mg/m3 | Rat | inhalation | - | ECHA |
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Warning
Pictograms
Environmental Hazard
Hazard Class and Category
Aquatic Acute 1; Aquatic Chronic 1
Hazard Statements
- H400 Very toxic to aquatic life
- H410 Very toxic to aquatic life with long lasting effects
Inserted via ATP: CLP00
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: other
Receptor targets: steroidogenic enzymes (limited)
LOEC: 1 µg/mL
EU status: allowed (non-nano); under review for nano aerosolized
modulator (limited)
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100,000 - 1,000,000 tonnes
Substance Type
SUBSTANCE; GROUP
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex IV — Permitted Colorants
Product type: White
Annex VI — Permitted UV Filters
Max: 25%
- In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%
Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.
Only nanomaterials having the following characteristics are allowed:
— purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total,
— median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm,
— water solubility < 50 mg/L
—uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross- polymer, or octyl triethoxy silane.
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
KR Korea MFDS Annex 2 (Restricted)
Category: UV Filter. Max: 25%.
SA Saudi SFDA (IV - Colorants)
JPKR Japan/Korea Cosmetics
Korea (Restricted): max 25.0
BRIN Brazil/India Cosmetics
India: Permitted UV Filter · max - 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%
India: Permitted UV Filter · max 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%
India: Permitted Colorant
Additional Jurisdictional Restrictions (4)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_uv_filter | 25 | All cosmetics |
| BR | permitted_uv_filter | 25 | Sunscreen products; nano form NOT permitted |
| ASEAN | permitted_uv_filter | 25% | - |
| ASEAN | permitted_colorant | - | All products (see also Annex VII UV filter) |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (3 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_in_vitro | 0.0 | In vivo — human studies (tape-stripping, ICP-MS) | - | SCCS/1481/12; SCCS/1569/15 (2012) |
| measured_in_vitro | 0.055 | - | - | SCCS/1518/13 |
| measured_in_vitro | 0.3 | - | - | SCCS/1489/12 |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Sunscreen | 2–25 | 25 | CIR Safety Assessment |
| Diaper Cream | 5–40 | 40 | CIR Safety Assessment |
Additional Ingredient Properties
10 property records from structured ingredient metadata.
acne
{"cas_number": "1314-13-2", "anti_acne_mechanism": "antibacterial/anti_inflammatory/sebum_regulation", "comedogenicity_rating_0_to_5": "1", "acne_type_efficacy": "inflammatory", "p_acnes_mic_ug_per_ml": "Variable (antimicrobial)", "sebum_reduction_pct_clinical": "10-15", "optimal_ph_for_efficacy": "6.0-8.0", "prescription_required_usa": "No", "otc_drug_monograph_category": "Yes (sunscreen)", "max_…
allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "metal", "patch_test_frequency_pct": "0.1", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA 2019/20; NACDG 2021-22"}
anti_aging
{"anti_aging_claim": "antioxidant-protection, anti-inflammatory", "mechanism_of_action": "Cofactor for enzymatic reactions, antioxidant activity", "target_skin_layer": "epidermis", "collagen_stimulation": "Mild", "elastin_protection": "Mild", "wrinkle_reduction_pct": "3-8", "clinical_study_duration_weeks": "12", "sample_size": "30", "double_blind": "Yes", "placebo_controlled": "Yes", "published_jo…
anti_pollution
{"cas_number": "1314-13-2", "ingredient_class": "blue_light_filter", "primary_mechanism": "film_forming_barrier", "pollution_types_targeted": "blue_light_HEV/UV_A/UV_B", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modu…
baby_pediatric
{"cas_number": "1314-13-2", "ingredient_class": "barrier_cream", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "GOLD STANDARD: Barrier protectant, FDA OTC monograph, safe", "transepidermal_absorption_risk_pediatric": "very_low", "dose_per_kg_body_weight_concern": "Non-absorbed topica…
colorant_formulator
{"ci_number": "77947", "ci_name": "Pigment White 4", "color_category": "white", "color_hex_code": "#FFFFF0", "natural_or_synthetic": "synthetic", "organic_or_inorganic": "inorganic", "lake_or_dye": "pigment", "fda_approved_use": "lip/eye/general", "eu_approved_cosmetic": "yes", "japan_approved": "yes", "china_approved": "yes", "coverage_opacity": "semi_opaque", "tinting_strength": "high", "lightfa…
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "0", "skin_type_suitability": "all,oily,dry,sensitive,combination,normal,acne-prone,rosacea", "acne_safe": "yes", "source": "Physical blocker"}
concentration
{"min_concentration_pct": "5.0", "max_concentration_pct": "20.0", "typical_concentration_pct": "15.0", "product_type": "Tinted Moisturizer SPF", "function_at_concentration": "Physical UV filter", "source": "FDA OTC Monograph"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Adhesion/cohesion promoter
Anti-static agent
Antioxidant
Biocide
Catalyst
Chemical reaction regulator
Corrosion inhibitor
Dispersing agent
Drier
Dye
Regulatory List Membership (5)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Zinc Oxide.
Regulatory Flags
mineral-filter
broad-spectrum
uva-uvb
uva1-only-us-single-ingredient
grase
reef-safe
nano-permitted
spray-ban-eu
nano-label-required-eu
photostable
white-cast
ros-generation-concern
coating-optimisation-critical
powder-additional-data-required-fda
inhalation-risk-spray-powder
nano-transparency-20-100nm
endocrine_disruptor
eu_children_restricted
ifra_fragrance
fda_food_additive
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Zinc Oxide by CAS number or substance name.
Studies
44
Lowest NOAEL
0.0225
Highest NOAEL
1000
Units vary across source rows: mg/kg bw/d, mg/kg bw/day, mg/kg/d
SCCS Opinion
ECHA
SCCNFP Opinion
COSMOS DB
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 0.0 | In vivo — human studies (tape-stripping, ICP-MS) | Sunscreen formulations |
| 0.055 | - | - |
| 0.3 | - | - |
Known Synonyms
ZnO
Oxozinc
Zinc, oxo-
Zinc oxide (ZnO)
Akro-zinc bar 85
Akro-zinc bar 90
Azodox-55TT
Blanc de Zinc
Cadox XX 78
Caswell No. 920
Chinese White
CI Pigment white 4
EINECS 215-222-5
Electox 2500
Emanay zinc oxide
EPA Pesticide Chemical Code 088502
Felling zinc oxide
Flores de zinci
Green seal-8
Chemical Function
Pigment
Humectant
Dye
UV stabilizer
Filler
Regulatory Lists
Europe; Personal care
drinking_water; Europe; manufacturing; plastic_additive
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
inert_ingredient; Pesticides
Europe; nondetect; Toys and children's products
pharmaceutical
Personal care
active_ingredient; Europe; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
ZINC OXIDE
ChEMBL ID
CHEMBL3988900
Max Phase
4
Adverse Event Associations
1827
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Zinc oxide (color)
Food Category
colorant
Frequently Asked Questions
Is Zinc Oxide allowed in the EU?
Zinc Oxide EU regulatory status: restricted. Maximum allowed concentration: 25%. This is based on EU Regulation 1223/2009 and its amendments.
What does Zinc Oxide do in cosmetics?
Zinc Oxide functions as: Broad-spectrum inorganic UV filter (UVA + UVB); reflects, scatters, and absorbs radiation; surface coating type determines photocatalytic safety; also used as skin-conditioning and astringent agent. It is classified as a Active Ingredient in our database. CAS number: 1314-13-2.
What is the NOAEL for Zinc Oxide?
The NOAEL (No Observed Adverse Effect Level) for Zinc Oxide is 45 mg/kg bw/day based on a Short Term Toxicity study via oral route in swine. A total of 10 study endpoints are available. Source: COSMOS DB.
Is Zinc Oxide classified as hazardous under GHS?
Zinc Oxide carries a GHS signal word of "WARNING". Hazard statements: Very toxic to aquatic life with long lasting effects. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Is Zinc Oxide used outside cosmetics?
Zinc Oxide also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Zinc Oxide compliance across multiple jurisdictions:
Ingredient Decoder
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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