MULTI PROTECTION UV BOUNCER- octinoxate, octocrylene, octisalate cream

Multi Protection UV Bouncer by

Drug Labeling and Warnings

Multi Protection UV Bouncer by is a Otc medication manufactured, distributed, or labeled by Codecosme International Co., Ltd., Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Octocrylene 5.00%, Ethylhexyl Salicylate 4.50%

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

Purpose: Sunscreen

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.

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

INGREDIENTS AND APPEARANCE

MULTI PROTECTION UV BOUNCER 
octinoxate, octocrylene, octisalate cream

Product 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)