Label: DONGINBI RED GINSENG PERFECT SUN- octinoxate, octisalate, zinc oxide, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 July 26, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 4.9%, Titanium Dioxide 2.9%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Dipropylene Glycol, Glycerin, PEG-10 Dimethicone, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Isoamyl p-Methoxycinnamate, Glyceryl Caprylate, Fragrance(Parfum), Aluminum Hydroxide, Stearic Acid, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Glycol, Ecklonia Cava Extract, Panax Ginseng Root Extract, Saccharide Isomerate, Ginsenosides, Camellia Sinensis Leaf Extract, Honey Extract, Portulaca Oleracea Extract, Cinnamomum Cassia Bark Extract, Chaenomeles Sinensis Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Chrysanthemum Indicum Flower Extract, Phenoxyethanol, Cnidium Officinale Root Extract, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben

  • 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: Do not use on hurt or abraded skin.

  • DESCRIPTION

    Uses: Apply an appropriate amount to your face then apply it along the skin texture, thin and wide, finish with massage.

    Directions: in the morning, as the last step in your basic routine, lightly apply a desired amount to your entire face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DONGINBI RED GINSENG  PERFECT SUN
    octinoxate, octisalate, zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69640-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.75 g  in 50 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.5 g  in 50 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.45 g  in 50 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.45 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69640-4001-21 in 1 CARTON03/08/2015
    1NDC:69640-4001-150 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 finalpart35203/08/2015
    Labeler - KGC LIFE&GIN (689680259)
    Registrant - KGC LIFE&GIN (689680259)
    Establishment
    NameAddressID/FEIBusiness Operations
    KGC LIFE&GIN689680259relabel(69640-4001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(69640-4001)
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