ULTRA V IDEBENONE SUNBLOCK (HOMOSALATE, AVOBENZONE, ENSULIZOLE) CREAM [ULTRA V CO., LTD]

ULTRA V IDEBENONE SUNBLOCK (HOMOSALATE, AVOBENZONE, ENSULIZOLE) CREAM [ULTRA V CO., LTD]
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NDC 71975-070-01, 71975-070-02
Set ID 98f96fbc-7607-4057-83f1-562fce9f6ea5
Category HUMAN OTC DRUG LABEL
Packager Ultra V Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: Homosalate 10%, Butyl Methoxydibenzoylmethane 3.5%, Phenylbenzimidazole Sulfonic Acid 3.5%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Glycerin, Acrylates Copolymer, Dibutyl Adipate, Methyl Methacrylate Crosspolymer, Niacinamide, Propanediol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Pentylene Glycol, Alcohol Denat., Aminomethyl Propanol, Caprylyl Methicone, Polymethylsilsesquioxane, Dimethicone, Behenyl Alcohol, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Carbomer, Phenoxyethandl, Tromethamine, Caprylyl Glycol, Xanthan Gum, Adenosine, Disodium EDTA, Boswellia Carterii Oil, Pelargonium Graveolens Flower Oil, Vetiveria Zizanoides Root Oil, Amyris Balsamifera Bark Oil, Butylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Daucus Carota Sativa (Carrot) Seed Oil, Hydrocydecyl Ubiquinone, Tocopheryl Acetate, Macadamia Integrifolia Seed Oil, Anthemis Nobilis Flower Water, Octyldodecanol, Curcuma Longa (Turmeric) Root Extract, Rice Ferment Filtrate (Sake), Dipropylene Glycol, Aspalathus Linearis Leaf Extract, Lactobacillus/Rice Ferment Filtrate, Saccharomyces/Camellia Sinensis Extract Ferment Filtrate, Propylene Glycol, Sodium Palmitoyl Proline, Rose Flower Oil, Averrhoa Carambola Fruit Extract, Lactobacillus Ferment, Echium Plantagineum Seed Oil, Nymphaea Alba Flower Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, 1,2-Hexanediol, Lactobacillus Ferment Filtrate, Lepidium Meyenii Root Extract, Mannitol, Vanilla Tahitensis Fruit Extract, Royal Jelly Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Magnolia Biondii Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Sodium Benzoate, Ethylhexylglycerin, Benzyl Alcohol, Chrysanthemum Boreale Flower Extract, Citric Acid, Potassium Sorbate, Tocopherol, Limonia Acidissima Extract, , Acetyl Hexapeptide-8, Dehydroacetic Acid, Hydrolyzed Coral, sh-Decapeptide-7, sh-Octapeptide-4, sh-Oligopeptide-9, sh-Pentapeptide-19, sh-Oligopeptide-1

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children.

  • DESCRIPTION

    Uses: Helpe sunscreen agent skin

    Directions: Apply liberally and uniformly to all exposed areas before sun exposure. Reapply often(every 2hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection

  • QUESTIONS

    Questions:

    TEL,+82-539-3450

    www.ultravcosmetic.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ULTRA V IDEBENONE SUNBLOCK 
    homosalate, avobenzone, ensulizole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71975-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate5.00 g  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.75 g  in 50 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.75 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71975-070-021 in 1 CARTON01/02/2018
    1NDC:71975-070-0150 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 finalpart35201/02/2018
    Labeler - Ultra V Co., Ltd (689004748)
    Registrant - Ultra V Co., Ltd (689004748)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(71975-070)

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