NDC | 71786-010-01, 71786-010-02 |
Set ID | 11739ce7-c657-4593-a1a6-a9d747860ab4 |
Category | HUMAN OTC DRUG LABEL |
Packager | Codecosme International Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Water, Alcohol Denat., Butylene Glycol, Butyl Methoxydibenzoylmethane, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Silica, Methyl Methacrylate Crosspolymer, Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate, Crosspolymer, Fragrance, Isohexadecane, Caprylyl Glycol, Potassium Hydroxide, Polysorbate 80, Phenoxyethanol, 1,2-Hexanediol, Ethylhexylglycerin, BHT, Citrus Aurantifolia (Lime) Oil, Disodium EDTA, Buddleja Axillaris Leaf Extract, Phyllostachis Bambusoides Juice, Malpighia Emarginata (Acerola) Fruit Extract, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Sorbaria Sorbifolia Bark/Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Carex Humillis Root Extract, Nelumbo Nucifera Flower Extract, Lilium Candidum Bulb Extract, Alcohol, Syringa Vulgaris (Lilac) Extract, Glycine, Serine, Glutamic Acid, Saussurea Involucrata Extract, Aspartic acid, Leucine, Camellia Sinensis Leaf Extract, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Threonine, Proline, Valine, Isoleucine, Aloe Barbadensis Leaf Extract, Psidium Guajava Leaf Extract, Abronia Villosa Leaf Extract, Cinchona Succirubra Bark Extract, Chenopodium Quinoa Seed Extract, Histidine, Methionine, Cysteine, Rhodiola Rosea Root Extract, Oxygen
- PURPOSE
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WARNINGS
Warnings: 1. If any of the following symptoms occur when using the product, stop using immediately and consult a dermatologist. a) red spots, swelling, itchy rashes other skin irritations, etc. b) if a) occurs after applying and being exposed to sunlight. 2. Do not use on wounds, inflamed skin, itchy areas, or other infected areas. 3. Storage and handling: a) must close cap after use. b) Keep out of reach of children. c) keep away from extreme heat, cold and direct sunlight. d) Avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water. 4. For external use only.
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DESCRIPTION
Uses: A cooling and moisturizing UV protector/makeup primer. When applied, it protects the skin from UV rays and leaves a beautiful sheen. Contains internationally renowned Korean Jeju hypoxic water and British Harrogate sparkling water.
Directions: Pump appropriate amount of the product onto your hands and apply on the entire face in outward strokes using a sponge or fingertips. If required, reapply it on areas that are vulnerable to sunlight such as cheekbones, nasal bridge, and forehead. Close cap after use.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MULTI PROTECTION UV BOUNCER
octinoxate, octocrylene, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71786-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 3.5 g in 50 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 2.5 g in 50 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 2.25 g in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71786-010-02 1 in 1 CARTON 10/01/2017 1 NDC:71786-010-01 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2017 Labeler - Codecosme International Co., Ltd. (689846614) Registrant - Codecosme International Co., Ltd. (689846614) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(71786-010)