PROVENCE INTENSIVE AMPOULE FOUNDATION Y21 PURE VANILLA (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [NATURE REPUBLIC CO., LTD.]

PROVENCE INTENSIVE AMPOULE FOUNDATION Y21 PURE VANILLA (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [NATURE REPUBLIC CO., LTD.]
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NDC 51346-512-01, 51346-512-02
Set ID 659e5d59-6278-4cc9-89fd-2c7f3aa21443
Category HUMAN OTC DRUG LABEL
Packager NATURE REPUBLIC CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients:
    Titanium Dioxide 13.36%, Zinc Oxide 1.92%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, DIPHENYLSILOXY PHENYL TRIMETHICONE, CYCLOPENTASILOXANE, METHYL TRIMETHICONE, ISOTRIDECYL ISONONANOATE, ALCOHOL, DIPROPYLENE GLYCOL, PENTAERYTHRITYL TETRAETHYLHEXANOATE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, DIISOSTEARYL MALATE, NIACINAMIDE, IRON OXIDES(CI 77492), METHYL METHACRYLATE CROSSPOLYMER, CETYL PEG/PPG-10/1 DIMETHICONE, SORBITAN SESQUIOLEATE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, BEESWAX, PHENOXYETHANOL, ACRYLATES/DIMETHICONE COPOLYMER, OZOKERITE, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES(CI 77491), FRAGRANCE, ALUMINUM HYDROXIDE, SILICA DIMETHYL SILYLATE, STEARIC ACID, IRON OXIDES(CI 77499), ETHYLHEXYLGLYCERIN, METHICONE,ADENOSINE, SODIUM HYALURONATE, CAMELLIA JAPONICA SEED OIL, ROSA CANINA FRUIT OIL, CALENDULA OFFICINALIS FLOWER EXTRACT, HYDROGENATED POLYISOBUTENE, HYDROLYZED HYALURONIC ACID, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WATER, LIPPIA CITRIODORA LEAF EXTRACT, CENTAUREA CYANUS FLOWER WATER, BUTYLENE GLYCOL, GLYCERIN, TOCOPHEROL, MORINGA OLEIFERA SEED EXTRACT, 1,2-HEXANEDIOL, RHODODENDRON FERRUGINEUM EXTRACT, PANAX GINSENG ROOT EXTRACT, ETHYL HEXANEDIOL,BENZYL ALCOHOL, SODIUM BENZOATE, CITRIC ACID, SILK AMINO ACIDS, PROPOLIS EXTRACT, ROYAL JELLY EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, CORNUS OFFICINALIS FRUIT EXTRACT, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, SALMON EGG EXTRACT, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, DEHYDROACETIC ACID, SQUALANE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ANEMARRHENA ASPHODELOIDES ROOT EXTRACT

  • 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:
    The foundation makes skin look smooth and provides moisture with its ampoule ingredients.
    Helps prevent sunburn

    Directions
    Fully shake the container. Apply an appropriate amount on the face in the direction of skin texture. Gently pat as a finishing touch.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PROVENCE INTENSIVE AMPOULE FOUNDATION Y21 PURE VANILLA 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-512
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.00 g  in 30 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.57 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51346-512-021 in 1 CARTON12/01/2018
    1NDC:51346-512-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2018
    Labeler - NATURE REPUBLIC CO., LTD. (631172020)
    Registrant - NATURE REPUBLIC CO., LTD. (631172020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(51346-512)

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