EASYDEW EG SUN ULTRA SHIELD (HOMOSALATE, AVOBENZONE, ENSULIZOLE) CREAM [DN COMPANY CO.,LTD.]

EASYDEW EG SUN ULTRA SHIELD (HOMOSALATE, AVOBENZONE, ENSULIZOLE) CREAM [DN COMPANY CO.,LTD.]
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NDC 60565-280-01, 60565-280-02
Set ID 23ea526b-cb51-40f5-bc28-d4e238b718d3
Category HUMAN OTC DRUG LABEL
Packager DN Company Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: Homosalate 10.0%, Butyl Methoxydibenzoylmethane 3.5%, Phenylbenzimidazole Sulfonic Acid 3.5%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Butyloctyl Salicylate, Butylene Glycol, Ethylhexyl Methoxycrylene, Dicaprylyl Carbonate, Dipropylene Glycol, Cyclopentasiloxane, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cetearyl Alcohol, Aminomethyl Propanol, Cyclohexasiloxane, Caprylyl Methicone, Pentylene Glycol, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Triceteareth-4 Phosphate, Glycol Stearate, Methyl Methacrylate Crosspolymer, Silica, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Phenoxyethanol, Fragrance(Parfum), Caprylyl Glycol, Xanthan Gum, Caprylic/Capric Triglyceride, Alcohol, Disodium EDTA, 1,2-Hexanediol, Hydrogenated Lecithin, Propylene Glycol, Hydrogenated Phosphatidylcholine, Alcohol Denat., Sodium Stearoyl Glutamate, Ceramide 3, Cholesterol, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Pinus Pumilio Bark Extract, Poterium Officinale Root Extract, Veronica Officinalis Extract

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    For external use only

    Help prevent sunburn.

    If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • DESCRIPTION

    Uses:

    Help prevent sunburn.

    If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

    Directions:

    At the last stage of your skincare routine, evenly apply onto face.

    Use a suitable amount of hair treatment according to the number of hair.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    EASYDEW EG SUN ULTRA SHIELD 
    homosalate, avobenzone, ensulizole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60565-280
    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)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60565-280-021 in 1 CARTON06/01/2018
    1NDC:60565-280-0150 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 finalpart35206/01/2018
    Labeler - DN Company Co.,Ltd. (688369859)
    Registrant - DN Company Co.,Ltd. (688369859)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60565-280)

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