Zinc oxide
Zinc oxide. (a) Identity and specifications. The color additive zinc oxide shall conform in identity and specifications to the requirements of § 73.1991 (a)(1) and (b). (b) Uses and restrictions. Zinc oxide may be safely used in cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 37538, July 22, 1977]
Regulatory decision and full conditions
- Status
- Permitted list with conditions
- Legal role
- Binding rule
- Regulatory summary
- Zinc oxide. (a) Identity and specifications. The color additive zinc oxide shall conform in identity and specifications to the requirements of § 73.1991 (a)(1) and (b). (b) Uses and restrictions. Zinc oxide may be safely used in cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 37538, July 22, 1977]
- Conditions and restrictions
- Zinc oxide. (a) Identity and specifications. The color additive zinc oxide shall conform in identity and specifications to the requirements of § 73.1991 (a)(1) and (b). (b) Uses and restrictions. Zinc oxide may be safely used in cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 37538, July 22, 1977]
Substance identity
- Official source name
- Zinc oxide
- CAS
- 1314-13-2
- EC
- 215-222-5
- Identity mapping
- name
- Linked ingredient
- ZINC OXIDE
Linked CosIng identity data
Names and aliases
CosIng description: Zinc oxide (CI 77947)
EU inventory restriction note: IV/144 VI/30 VI/30a
Recorded cosmetic function: ANTIMICROBIAL, BULKING, COLORANT, LIGHT STABILIZER, ORAL CARE, SKIN PROTECTING, UV ABSORBER, UV FILTER
Function pages:ANTIMICROBIAL, BULKING, COLORANT, LIGHT STABILIZER, ORAL CARE, SKIN PROTECTING, UV ABSORBER, UV FILTER
View the complete ingredient profileCross-market snapshot for this identity
Exact linked records currently present in this site. An absent market means no imported exact match, not permission to use the substance.
European Union
3 linked records · 3 with specific conditions
Open supporting recordGreat Britain
3 linked records · 3 with specific conditions
Open supporting recordNew Zealand
3 linked records · 3 with specific conditions
Open supporting recordASEAN
2 linked records · 2 with specific conditions
Open supporting recordSouth Korea
1 linked record · 1 with specific conditions
Open supporting recordUnited States
Current record1 linked record · 1 with specific conditions
Open supporting recordVerified chemistry for CAS 1314-13-2
Zinc Oxide
- IUPAC name
- zinc oxygen(2-)
- Molecular formula
- OZn
- Molecular weight
- 81.4 g/mol
- Exact mass
- 79.924056 Da
- Monoisotopic mass
- 79.924056 Da
- Topological polar surface area
- 1.0 Ų
- Molecular complexity
- 0.0
- Formal charge
- 0
- Hydrogen-bond donors
- 0
- Hydrogen-bond acceptors
- 1
- Rotatable bonds
- 0
- Heavy atoms
- 2
- Covalent units
- 2
Names and synonyms reported to PubChem
16 more reported names
External database identifiers
Advanced structure statistics
- Defined atom stereocentres
- 0
- Undefined atom stereocentres
- 0
- Defined bond stereocentres
- 0
- Undefined bond stereocentres
- 0
- 3D conformers
- 0
Machine-readable structure identifiers
- SMILES
[O-2].[Zn+2]- InChI
InChI=1S/O.Zn/q-2;+2- InChIKey
RNWHGQJWIACOKP-UHFFFAOYSA-N
Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.
Official source and provenance
- Registered source
- US FDA cosmetic ingredient framework
- Source reference
- 21 CFR 73.2991
- Source record ID
73.2991- Source version
- 2026-08-27
- Source language
- English
- Translation status
- Original is English
- Source updated
- 2026-08-27
- Snapshot checked
- 2026-08-30 04:30 UTC
- Validation method
- eCFR XML subpart/section parse; 99 records
- SHA-256
25a55a997379f510077dfb234fe3f366e8a1429cec3d0b20fe4b60e2baf3c36d
Registered dataset notes
- Dataset coverage
- Federal ingredient framework, prohibited/restricted examples and color-additive rules
- Authority note
- The US has no EU-style general approved-ingredient catalogue; MoCRA listing is not approval
How this record fits the market dataset
Status distribution
Condition text is present on 90 of 99 current records. An empty condition field is interpreted according to the record type above; it is never converted into an unrestricted-use claim.
United States market context
Complete enumerated federal ingredient rules
Coverage version: eCFR Title 21 issue date 27 August 2026
All cosmetic prohibitions/restrictions in Part 700 Subpart B and cosmetic-use colour additive listings in Parts 73, 74 and 82.
Verification checklist
- Search Part 700 and all relevant colour-additive parts.
- Confirm colour additive identity, permitted uses, limits and certification status.
- Assess safety and adulteration under the FD&C Act.
- Complete MoCRA facility/product, adverse-event and label obligations where applicable.
Official market sources
- US FDA cosmetic ingredient frameworkThe US has no EU-style general approved-ingredient catalogue; MoCRA listing is not approval
Verification workflow and record completeness
Before using this result in a compliance decision
- Confirm that “Zinc oxide” and every CAS/EC identifier refer to the material in your supplier specification.
- Search Part 700 and all relevant colour-additive parts.
- Confirm colour additive identity, permitted uses, limits and certification status.
- Assess safety and adulteration under the FD&C Act.
- Complete MoCRA facility/product, adverse-event and label obligations where applicable.
- Document the source version and recheck the regulator before manufacture, notification or market placement.
Fields available in this record
- Official substance nameAvailable
- CASAvailable
- ECAvailable
- Separate condition textAvailable
- Effective dateNot supplied
- Snapshot hash and methodAvailable
Questions this page answers
Stable citation
Zinc oxide. 21 CFR 73.2991. United States. Source version 2026-08-27. CosIng Checker regulatory record: https://cosingchecker.com/regulations/us/records/751/
Cite the regulator as the legal authority. This page is a structured evidence index and verification aid, not a substitute for the official text or professional legal assessment.
Interpretation and limits for United States
This identity appears on a market positive list for the list function represented by the source record.
Confirm that the intended function and product use fall within the list scope and every stated condition.
How to interpret the legal role
The cited row forms part of a binding rule or legally incorporated list for this market.
Evidence on this page
- Recorded outcome: Permitted list with conditions
- Legal role: Binding rule
- Source version: 2026-08-27
What it does not prove
FDA has no general approved-cosmetic-ingredient catalogue; absence from these sections is not approval or proof of safety.
Further authoritative substance research
These sources can add identity, safety, exposure or hazard context. A link is not evidence that the database contains this exact substance, and none of these sources overrides the market decision above.
Cosmetic Ingredient Review safety assessments
Expert Panel conclusions, assessed ingredient groups, use conditions, dates and report documents
Independent expert review considered by FDA; not a government approval or binding market rule
Research this identity at the sourceFDA Global Substance Registration System
UNII identifiers, preferred names, substance types, codes and public substance relationships
Identity registry only; UNII availability does not imply FDA review or approval
Research this identity at the sourceILO/WHO International Chemical Safety Cards
Hazards, symptoms, first aid, storage, incompatibilities and physical properties for covered chemicals
International occupational chemical-safety reference; not cosmetic-use approval
Research this identity at the sourceJapan NITE-CHRIP
Chemical identity, Japanese and foreign legal lists, GHS hazards and exposure-related information
Chemical-management evidence; cosmetic status remains governed by the applicable MHLW standard and market rules
Research this identity at the sourceNIOSH Pocket Guide to Chemical Hazards
REL, PEL, IDLH, properties, exposure routes, symptoms, target organs, first aid and measurement methods for covered workplace chemicals
US occupational-health guidance and limits; not a cosmetic ingredient decision
Research this identity at the sourceOECD eChemPortal
Gateway to authority-owned physical-property, fate, ecotoxicity, toxicity, exposure and GHS records
Discovery gateway; each linked authority remains responsible for its data
Research this identity at the sourceUS EPA CompTox CTX APIs
API key required for importDTXSID identity, experimental and predicted properties, toxicity, bioactivity, exposure and environmental data
Scientific and computational evidence; predictions must remain labelled and do not determine cosmetic legality
Research this identity at the source