Label: MULTI PROTECTION UV BOUNCER- octinoxate, octocrylene, octisalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 18, 2017

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  • 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

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MULTI PROTECTION UV BOUNCER 
    octinoxate, octocrylene, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71786-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.5 g  in 50 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene2.5 g  in 50 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.25 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71786-010-021 in 1 CARTON10/01/2017
    1NDC:71786-010-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2017
    Labeler - Codecosme International Co., Ltd. (689846614)
    Registrant - Codecosme International Co., Ltd. (689846614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca Korea Co., Ltd.688830827manufacture(71786-010)