UV BOUNCE MIST (OCTINOXATE, OCTISALATE) SPRAY [MIZON CO., LTD.]

UV BOUNCE MIST (OCTINOXATE, OCTISALATE) SPRAY [MIZON CO., LTD.]
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NDC 57718-030-01
Set ID 24d24776-0f5e-4218-b29f-e8461528a6c3
Category HUMAN OTC DRUG LABEL
Packager MIZON CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients: Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Butylene Glycol, Caprylic/Capric Triglyceride, Phenylbenzimidazole Sulfonic Acid, Disiloxane, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ceteareth-6 Olivate, Niacinamide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Tromethamine, Dimethicone, Tocopheryl Acetate, Benzyl Alcohol, Microcrystalline Cellulose, Fragrance, Portulaca Oleracea Extract, Phenoxyethanol, Sodium Benzoate, Disodium EDTA, Potassium Sorbate, Glycerin, Cetearyl Olivate, Sorbitan Olivate, Adenosine, Cellulose Gum, Alpinia Officinarum Root Extract, Lactobacillus/Nelumbo Nucifera Seed Ferment Filtrate, Citrullus Lanatus (Watermelon) Fruit Extract, Terminalia Chebula Fruit Extract, Abies Koreana Leaf Extract, Aloe Barbadensis Leaf Juice

  • PURPOSE

    Purpose: UVA/UVB Protection

  • WARNINGS

    Warnings:
    1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.
    2. Do not use on scarred skin, or if you have dermatitis or eczema
    3. Keep the cap close on its product
    4. Keep away from direct sunlight or heat.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of babies and children

  • INDICATIONS AND USAGE

    Indication and Usage:
    Spray onto areas exposed to UV rays from about 20-30cm aways. (Use before or after makeup.)

  • DOSAGE AND ADMINISTRATION

    Dosage and Administration:
    2-3 time spry onto the areas that exposed to UV rays, and tap on applied skin for better aborption.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    UV BOUNCE MIST 
    octinoxate, octisalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57718-030-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2014
    Labeler - MIZON CO., LTD. (557815570)
    Registrant - MIZON CO., LTD. (557815570)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIZON CO., LTD.557815570manufacture(57718-030)

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