CI 77947

B

uno o dos ensayos aleatorizados

Registro de sustancias de la FDA (EE. UU.) · UNII SOI2LOH54Z · nombre registrado Zinc oxide · sustancia química única

Fuente: Identificador único de ingredientes de la FDA (UNII)

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

Filtro UV permitido

Reino Unido

Colorante permitido

Reino Unido

Fuente: Directiva cosmética de la ASEAN · Reglamento de cosméticos de la UE · Ingredientes cosméticos de la FDA de Taiwán · Normativa cosmética del Reino Unido (OPSS) · Aditivos de color de la FDA · Ingredientes prohibidos y restringidos de la FDA

Argentina · Brasil

• Maximum concentration permitted at final product : 25%

ASEAN

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

Canadá

• Maximum Concentration Permitted : ≤ 25%

Taiwán

• 25%

Estados Unidos

• 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

• Concentración máxima : 25%

Corea del Sur

• ∙ 25%
• CI Number : CI 77947

Unión Europea

• 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.

Clasificación GHS de sustancias tóxicas de Corea: Atención · H410 (categoría 1) · H400 (categoría 1)

Fuente: Registro GHS de sustancias tóxicas de Corea (NIER)

Reglamento de cosméticos de la UE, anexo VI (filtros UV permitidos), entrada 30 · concentración máxima - 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%

Fuente: Filtros UV permitidos UE (anexo VI)

Reglamento de cosméticos de la UE, anexo IV (colorantes permitidos), entrada 144

Fuente: Colorantes permitidos UE (anexo IV)

Reglamento de cosméticos de la UE, anexo VI (filtros UV permitidos), entrada 30a · concentración máxima 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%

Fuente: Filtros UV permitidos UE (anexo VI)

Restriction IV/144

Fuente: Lista de ingredientes CosIng (UE)

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

Fuente: Lista de ingredientes CosIng (UE)