CI 77947 is classed chemically as an inorganic colour (see also INCI: Zinc Oxide).
- Skin barrier B-
- Set amount
- 1–25% (FDA skin protectant monograph)
- When
- morning
- Irritation
- low
- Korean limit
- 25%
Grades were set by reading this ingredient’s studies. They describe the ingredient, not every product that contains it.
How much products actually contain
13 products state the amountmedian 10%100% at or above the amount studies used (1–25% (FDA skin protectant monograph))
- under 0.01% 0
- 0.01–0.1% 0
- 0.1–1% 0
- 1% or more 13
Amounts are mostly stated by products named after the ingredient, so they may lean towards token amounts.
Of the products containing it, 298 list it before the 1% line and 40 after it (usually 1% or less).
Where no amount is stated, a product listing it early reaches the study amount about 83% of the time, one listing it late about 5%.
Clinical evidence grade by skin concern
- B
- one or two randomised trials
1 references
- FDA OTC monograph M016, skin protectant active ingredients
Products using this ingredient
12 of 328 confirmed · likeliest to carry enough first · See all 328
Sun BumSun Bum Baby Bum Mineral SPF 50 Sunscreen Lotion20% stated · study amount
Sun BumSun Bum Baby Bum Mineral SPF 50 Sunscreen Face Stick19% stated · study amount
ATOPALMZinc Mild Up Sun Cream 65g19% stated · study amount
Peach & LilyPeach & Lily Sun Cover Mineral Sunscreen16% stated · study amount
SidmoolMelabye Aqua Mineral Sun Lotion15% stated · study amount
BARULABZinc 11.9% Trouble Rescue Cream12% stated · study amount
MuradMurad City Skin Age Defense Broad Spectrum SPF 50 | PA++++10% stated · study amount
SidmoolDr. Troub Bio Repair Suncream SPF40 PA++10% stated · study amount
SidmoolDr. Troub Blemish Spot Concealer10% stated · study amount
TOSOWOONGZinc Oxide 10% Cream10% stated · study amount
SidmoolDr. Troub Blemish Spot Liquid Concealer10% stated · study amount
SidmoolGalatokside Zinc Mask (Wash-Off)7% stated · study amount
Definition
US FDA substance register · UNII SOI2LOH54Z · registered name Zinc oxide · single chemical substance
CI 77947 is classed chemically as an inorganic colour (see also INCI: Zinc Oxide). It conforms to the formula:
Cosmetic roles
Safety & regulatory references
- Allowed UV filter
- United Kingdom
- Allowed colourant
- United Kingdom
Source: ASEAN Cosmetic Directive · EU Cosmetics Regulation · Taiwan FDA cosmetic ingredients · UK cosmetics regulations (OPSS) · US FDA color additives · US FDA prohibited and restricted ingredients
Argentina · Brazil
- Maximum concentration permitted at final product : 25%
ASEAN
- Maximum authorised concentration in the finished cosmetic product : 25%
Canada
- Maximum Concentration Permitted : ≤ 25%
Taiwan
- 25%
United States
- Specific Limitations and Comments : Use of the term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labelling must also state why the sunscreen ingredient is used, for example, "Contains a sunscreen to protect product color." If this explanation isn’t present, the product may be subject to regulation as a drug (21 CFR 700.35). For more information on sunscreens, refer to Tanning Products
China
- Maximum concentration : 25%
South Korea
- ∙ 25%
- CI Number : CI 77947
European Union
- Maximum concentration in ready for use preparation : 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%
- Wording of conditions of use and warnings : Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.
- Maximum concentration in ready for use preparation : 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%
- Wording of conditions of use and warnings : 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.
Source: MFDS (Korea) cosmetic regulatory information
Korea’s toxic-substance GHS classification: Warning · H410 (category 1) · H400 (category 1)
EU Cosmetics Regulation, Annex VI (allowed UV filters), entry 30 · maximum concentration - 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%
Source: EU allowed UV filters (Annex VI)
EU Cosmetics Regulation, Annex IV (allowed colourants), entry 144
Source: EU allowed colourants (Annex IV)
EU Cosmetics Regulation, Annex VI (allowed UV filters), entry 30a · maximum concentration 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%
Source: EU allowed UV filters (Annex VI)
Restriction IV/144
Source: EU CosIng ingredient list
Restriction IV/144 VI/30 VI/30a · Other restriction: ban substances that deplete the ozone layer · SCCS opinion: Clarification on Opinion SCCNFP/0932/05 on Zinc Oxide; Opinion concerning Zinc oxide; Opinion on Safety of Nanomaterials in Cosmetic Products; OPINION ON Zinc oxide - nano form; Statement on Zinc Oxide used in Sunscreens
Source: EU CosIng ingredient list
More data — names, identifiers, properties, test records, literature
Official labels & definitions
JCIA labelling name 酸化亜鉛: 本品は、亜鉛の酸化物であり、次の化学式で表される。
Source: JCIA labelling names (Japan)
Names & identifiers
- CAS No.chemical registry number
- 1314-13-2
- EC No.EU chemical inventory number
- 215-222-5
- DTXSIDUS EPA chemical ID
- DTXSID7035016
- DTXCIDUS EPA compound ID
- DTXCID30820697
- IUPAC
- Zinc oxide
- Molecular formula
- OZn
- Molecular weight
- 81.38 g/mol
Measured properties
- Odour
- odourless
- pH
- 6.95
- Melting/freezing point
- &, gt, 1000 ℃
- Vapour pressure
- 0 ㎜Hg
- Water solubility
- 2.9 ㎎/ℓ (20℃, pH: 6.07~6.55)
- Vapour density
- 5.6 g/㎤
- Relative density
- 5.68
- Molecular weight
- 81.41
Values measured on the substance itself. The KOSHA data are a reference for writing and reviewing safety data sheets, not a specification for a commercial raw material.
Source: KOSHA safety data sheets (Korea)
What products actually use it for
What the 287 products reported to the US EPA with this ingredient use it for. Products outside cosmetics are included, so the top few rows are its main uses.
- Filler31
- Dye27
- Chemical reaction regulator26
- Catalyst21
- Processing aids not otherwise specified21
- UV stabilizer19
- Pigment15
- No specific technical function15
39 other uses
- Biocide11
- Surface modifier7
- Humectant7
- Stabilizing agent7
- Soil amendments6
- pH regulating agent5
- Corrosion inhibitor5
- Hardener5
- Antioxidant5
- Heat stabilizer5
- Intermediate4
- Lubricating agent4
- Polymerization promoter3
- Drier2
- Adhesion/cohesion promoter2
- Viscosity modifier2
- Anti-streaking agent2
- Sealant (barrier)2
- Bleaching agent2
- Diluent2
- Fuel2
- Elasticizer2
- Pharmaceutical (EPA)2
- Flame retardant2
- Dispersing agent2
- Solids separation (precipitating) agent, not other1
- Wetting agent (non-aqueous)1
- Oxidizing agent1
- Monomers1
- Absorbent1
- Anti-static agent1
- Reducing agent1
- Flavouring and nutrient1
- Dusting agent1
- Adsorbent1
- Surfactant (surface active agent)1
- Fragrance1
- Cleaning agent1
- Binder1
Source: US EPA CompTox dashboard
Irritation and sensitisation studies
7 skin studies and 6 eye studies are on record.
The study conclusions largely agree (100%). These tests are on the raw material itself; irritation at the amount in a finished product is a different question.
See all 13 studies
- Ambiguous
skin corrosion: in vitro / ex vivo · Screening · OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test) according to - Not classified
Skin Sensitization · Screening - Not likely to be sensitizing
skin sensitisation: in vivo (non-LLNA) · Screening · according to OECD Guideline 406 (Skin Sensitisation) according to EU Method B.6 (Skin Sensitisation) - Ambiguous
skin sensitisation: in vivo (non-LLNA) · Screening · according to OECD Guideline 406 (Skin Sensitisation) according to EU Method B.6 (Skin Sensitisation) - Studies Indicate No Significant Irritation
skin irritation: in vivo · Screening · other guideline: Federal hazardous substances Act Regulations (16CFR 1500.41) according to - Not classified
Skin Irritation · Screening - Studies Indicate No Significant Irritation
skin irritation: in vivo · Screening · OECD Guideline 404 (Acute Dermal Irritation / Corrosion) according to - Studies Indicate No Significant Irritation
eye irritation: in vitro / ex vivo · Screening · other guideline: MatTek Corporation, Ashland, MA 01721, USA: EpiOcularTM human cell construct: Procedure details, Version 3.1a of February 10, 2010. according to other guideline: Harbell J.W. et al. (2009): COLIPA Program on Optimization of Existing In Vitro Eye Irritation Assays for Entry into Formal Validation: Technology Transfer and Intra/Inter Laboratory Evaluation of EpiOcular Assay for Chemicals. Poster # 378, SOT 2009 according to - Studies Indicate No Significant Irritation
eye irritation: in vivo · Screening · EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) according to OECD Guideline 405 (Acute Eye Irritation / Corrosion) according to - Moderate or Mild Irritation
eye irritation: in vivo · Screening · other guideline: Federal hazardous substances Act Regulations (16CFR 1500.42) according to - Studies Indicate No Significant Irritation
eye irritation: in vivo · Screening · OECD Guideline 405 (Acute Eye Irritation / Corrosion) equivalent or similar to - Moderate or Mild Irritation
eye irritation: in vivo · Screening · OECD Guideline 405 (Acute Eye Irritation / Corrosion) equivalent or similar to - Not classified
Eye Irritation · Screening
Source: US EPA CompTox dashboard
Related literature
- Analysis and Discussion on the Skin Effect of Zinc Oxide Nonlinear Resistor · 2014
- Synthesis of Zinc Oxide Nanoparticles, Study of Structure, Properties and Applications in Medicine · 2024
- A comparative study between local application of 10% zinc oxide to a combination of 10% zinc oxide and tocopherol in treating infant’s diaper dermatitis · 2024
- Authenticity of Zinc Oxide Nanoparticles and Zinc Oxide Playing Vital Role in Wound Healing · 2021
- 004 Topical Zinc Oxide for Open Pilonidal Wounds · 2008
Linked databases 29
- ASEAN Cosmetic Directive
- Australian Industrial Chemicals Inventory (AICIS)
- ChEBI
- ChEMBL
- China inventory of existing ingredients (IECIC)
- EU allowed colourants (Annex IV)
- EU allowed UV filters (Annex VI) 2
- EU CosIng ingredient list 2 3
- EU Cosmetics Regulation
- EU SCCS safety opinions 2
- JCIA labelling names (Japan)
- Korea Cosmetic Association ingredient dictionary
- Korea toxic substances GHS register (NIER)
- KOSHA safety data sheets (Korea)
- MFDS (Korea) cosmetic ingredient register
- MFDS (Korea) cosmetic regulatory information 2 3 4
- NIST Chemistry WebBook
- Taiwan FDA cosmetic ingredients 2
- Tlooto literature search 2 3 4 5
- UK cosmetics regulations (OPSS) 2
- UniChem cross-reference IDs
- US EPA CompTox dashboard 2
- US EPA DSSTox chemical database
- US FDA color additives
- US FDA prohibited and restricted ingredients 2
- US FDA substance registration (GSRS)
- US FDA Unique Ingredient Identifier (UNII)
- Wikidata
- Wikipedia · Korean · English · Japanese · Chinese