Gloshell
成分词典

成分词典

CI 77947

CI 77947 is classed chemically as an inorganic colour (see also INCI: Zinc Oxide).

临床证据
  • 皮肤屏障 B-
规定含量
1–25% (FDA 皮肤保护剂专论)
使用时间
早上
刺激性
低
韩国限量
25%

等级依据对该成分研究文献的核查,描述的是成分本身,而非所有含该成分产品的功效。

分子结构

产品中实际含有多少

标示含量的产品 13 款中位数 10%100% 达到研究所用浓度(1–25% (FDA 皮肤保护剂专论))

  • 低于 0.01% 0
  • 0.01–0.1% 0
  • 0.1–1% 0
  • 1% 以上 13

标示含量的多为以该成分命名的产品,数值可能偏向象征性的少量添加。

含该成分的产品中,298 款将其列在 1% 线之前,40 款列在之后(通常不超过 1%)。

未标示含量的产品,若列在前面,约 83%、列在后面约 5% 的可能达到研究浓度。

按肌肤问题的临床证据等级

B
一至两项随机试验
参考文献 1 篇
  • FDA OTC monograph M016, skin protectant active ingredients

含有此成分的产品

已确认 328 款中的 12 款 · 按含量充足程度排序 · 查看全部 328 款

定义

美国FDA 物质登记 · UNII SOI2LOH54Z · 登记名称 Zinc oxide · 单一化学物质

来源: 美国FDA 物质识别码(UNII)

CI 77947 is classed chemically as an inorganic colour (see also INCI: Zinc Oxide). It conforms to the formula:

化妆品中的作用

防止光照导致颜色和香味变化LIGHT STABILIZER填充体积BULKING过滤紫外线保护肌肤(防晒功效成分)UV FILTER抑制微生物生长ANTIMICROBIAL着色COLORANT吸收紫外线(包括防止产品变质)UV ABSORBER护理口腔ORAL CARE保护肌肤免受外界刺激SKIN PROTECTING

安全与法规参考

准用防晒剂
英国
准用着色剂
英国

来源: 东盟化妆品指令 · 欧盟化妆品法规 · 台湾FDA 化妆品成分 · 英国化妆品法规 · 美国FDA 色素添加剂 · 美国FDA 禁用·限用成分

阿根廷 · 巴西

  • Maximum concentration permitted at final product : 25%

东盟

  • Maximum authorised concentration in the finished cosmetic product : 25%

加拿大

  • Maximum Concentration Permitted : ≤ 25%

台湾

  • 用途 : 防曬劑
  • 最大配合量 : 25% (倘作為收斂劑用途, 限量≤ 10%)
  • 25%

美国

  • 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

中国

  • 最大配合量 : 25%

韩国

  • ∙ 25%
  • CI Number : CI 77947

欧盟

  • 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.

来源: 韩国食药处 化妆品法规信息

韩国有毒物质 GHS 分类: 警告 · H410 (第1类) · H400 (第1类)

来源: 韩国有毒物质 GHS 信息(环境公团)

欧盟化妆品法规 附录VI(准用防晒剂) 第30项 · 最高浓度 - 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%

来源: 欧盟准用防晒剂(附录VI)

欧盟化妆品法规 附录IV(准用着色剂) 第144项

来源: 欧盟准用着色剂(附录IV)

欧盟化妆品法规 附录VI(准用防晒剂) 第30a项 · 最高浓度 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%

来源: 欧盟准用防晒剂(附录VI)

Restriction IV/144

来源: 欧盟 CosIng 成分清单

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

来源: 欧盟 CosIng 成分清单

详细资料——标示名称、识别编号、物性、试验记录、文献

官方标示名称和定义

日本化妆品工业联合会标示名称 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。

来源: 日本化妆品工业联合会标示名称

别名和识别信息

CI 77947INCI징크옥사이드韩国标示名称(食药处标准名)Zinc oxide (ZnO)同义名ZINC OXIDE同义名
CAS No.化学物质登记号
1314-13-2
EC No.欧盟化学品目录编号
215-222-5
DTXSID美国EPA化学品编号
DTXSID7035016
DTXCID美国EPA化合物编号
DTXCID30820697
IUPAC
Zinc oxide
分子式
OZn
分子量
81.38 g/mol

实测物性

气味
无臭
pH
6.95
熔点/凝固点
&amp, gt, 1000 ℃
蒸气压
0 ㎜Hg
溶解度
2.9 ㎎/ℓ (20℃, pH: 6.07~6.55)
蒸气密度
5.6 g/㎤
比重
5.68
分子量
81.41

这是对物质本身测得的数值。韩国安全保健公团(KOSHA)的资料仅供编写和审核安全数据表参考,并非原料商品的规格。

来源: 韩国安全保健公团 安全数据表

产品实际使用的用途

这是向美国 EPA 申报含该成分的 287 款产品的用途。其中包括化妆品以外的产品,排在前几行的即为该成分的主要用途。

  • Filler31
  • Dye27
  • Chemical reaction regulator26
  • Catalyst21
  • Processing aids not otherwise specified21
  • UV stabilizer19
  • Pigment15
  • No specific technical function15
其余用途 39 项
  • 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

来源: 美国EPA CompTox

刺激与致敏试验记录

记录有皮肤试验 7 项、眼部试验 6 项。

归类为低5 项

试验结论基本一致(100%)。 这是对原料本身的试验记录,与成品中所含浓度下的刺激性不同。

查看全部 13 项试验
  • 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

来源: 美国EPA CompTox

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