Good Cosmetic Ingredient NOAEL Data GHS Classified

CI 77947 (Zinc Oxide)

INCI: CI 77947

CAS Number
1314-13-2
Function
Colorant; UV Filter; Skin Protectant. Inorganic compound (ZnO) used as a white colorant, opacifier, and broad-spectrum physical UV filter in cosmetics and sunscreen products. Provides opacity, whitening effect, and broad-spectrum UVA/UVB protection. Used in foundations, face powders, sunscreens, lip products, baby care, and skin protectant formulations. SCCS concluded ZnO is safe when used as a colorant in its uncoated, non-nano form for dermal application. Both nano and non-nano forms are restricted to non-inhalable applications due to lung toxicity concerns.
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 25%
🇺🇸 US Status permitted
US Notes Listed as a color additive exempt from certification under 21 CFR 73.2991. Zinc Oxide may be safely used for coloring cosmetics applied to the skin, lips, and eye area in amounts consistent with good manufacturing practice. Also an FDA-approved OTC sunscreen active ingredient (21 CFR 352) at up to 25%. No equivalent US restriction on powder or spray inhalation formats.

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 CI 77947 (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.

Expert Verdict

Highly versatile and broadly approved inorganic colorant and UV filter with a well-established safety record for dermal applications. EU applies specific restrictions on inhalable formats (loose powders, sprays) for both nano and non-nano forms. US permits broad cosmetic and OTC sunscreen use without equivalent spray restrictions. SCCS supports safety for skin application in non-nano form.

⚠️
Concern Level: Low

Regulatory Flags

inorganic-colorant mineral-pigment eu-annex-iv eu-restricted-inhalable fda-exempt-certification otc-sunscreen uv-filter skin-protectant nano-scrutiny inhalation-restricted-eu widely-used eu_children_restricted ifra_fragrance fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is CI 77947 (Zinc Oxide) safe in cosmetics?

Highly versatile and broadly approved inorganic colorant and UV filter with a well-established safety record for dermal applications. EU applies specific restrictions on inhalable formats (loose powders, sprays) for both nano and non-nano forms. US permits broad cosmetic and OTC sunscreen use without equivalent spray restrictions. SCCS supports safety for skin application in non-nano form. The EU classifies CI 77947 (Zinc Oxide) as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is CI 77947 (Zinc Oxide) allowed in the EU?

CI 77947 (Zinc Oxide) EU regulatory status: restricted. Maximum allowed concentration: 25%. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 77947 (Zinc Oxide) do in cosmetics?

CI 77947 (Zinc Oxide) functions as: Colorant; UV Filter; Skin Protectant. Inorganic compound (ZnO) used as a white colorant, opacifier, and broad-spectrum physical UV filter in cosmetics and sunscreen products. Provides opacity, whitening effect, and broad-spectrum UVA/UVB protection. Used in foundations, face powders, sunscreens, lip products, baby care, and skin protectant formulations. SCCS concluded ZnO is safe when used as a colorant in its uncoated, non-nano form for dermal application. Both nano and non-nano forms are restricted to non-inhalable applications due to lung toxicity concerns.. It is classified as a cosmetic ingredient in our database. CAS number: 1314-13-2.

What is the Margin of Safety for CI 77947 (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 CI 77947 (Zinc Oxide)?

The NOAEL (No Observed Adverse Effect Level) for CI 77947 (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 CI 77947 (Zinc Oxide) classified as hazardous under GHS?

CI 77947 (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 CI 77947 (Zinc Oxide) compliance across multiple jurisdictions:

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