Excellent Active Ingredient NOAEL Data GHS Classified Sensitization Data Dermal Penetration

Zinc Oxide

INCI: ZINC OXIDE

CAS Number
1314-13-2
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 Status restricted
EU Max Conc. 25%
🇺🇸 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
low

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 606 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 600 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 400 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 400 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 172 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 99 mg/kg bw/day oral sheep Short Term Toxicity COSMOS_DB
NOAEL 149 mg/kg bw/day oral cattle Special Toxicology Study COSMOS_DB
NOAEL 45 mg/kg bw/day oral swine Short Term Toxicity COSMOS_DB

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
WARNING
Pictograms
enviro;aqua
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.

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/1518/13

Expert Verdict

One of two FDA GRASE sunscreen actives and uniquely the only single-ingredient US filter providing meaningful UVA1 coverage above 380 nm. Photostable, reef-safe, no endocrine concerns. Globally approved. Nano grades resolve white-cast limitations but require careful coating selection to minimize photoreactivity and ROS generation; EU spray ban applies to nano forms.

⚠️
Concern Level: Low

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

Frequently Asked Questions

Is Zinc Oxide safe in cosmetics?

One of two FDA GRASE sunscreen actives and uniquely the only single-ingredient US filter providing meaningful UVA1 coverage above 380 nm. Photostable, reef-safe, no endocrine concerns. Globally approved. Nano grades resolve white-cast limitations but require careful coating selection to minimize photoreactivity and ROS generation; EU spray ban applies to nano forms. The EU classifies Zinc Oxide as "restricted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

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 Margin of Safety for Zinc Oxide?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Zinc Oxide?

The NOAEL (No Observed Adverse Effect Level) for Zinc Oxide is 606 mg/kg bw/day based on a Special Toxicology Study study via oral route in rat. 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.

Compliance Tools

Check Zinc Oxide compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
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