VITA WATER DROP CC (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) CREAM [SKINFOOD CO., LTD.]

VITA WATER DROP CC (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) CREAM [SKINFOOD CO., LTD.]
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NDC 76214-048-01
Set ID 571031fa-ed21-43c2-b24b-d2094606ca8f
Category HUMAN OTC DRUG LABEL
Packager SKINFOOD CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredient: TITANIUM DIOXIDE 7.188%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ZINC OXIDE 0.985%

  • INACTIVE INGREDIENT

    Inactive ingredient:
    WATER, CYCLOPENTASILOXANE, CAPRYLYL METHICONE, METHYL TRIMETHICONE, GLYCERIN, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, ARBUTIN, DIPROPYLENE GLYCOL, TALC, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, BETAINE, CAPRYLYL GLYCOL, PYRUS MALUS (APPLE) FRUIT EXTRACT, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, CUCURBITA PEPO (PUMPKIN) FRUIT EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, BRASSICA OLERACEA CAPITATA (CABBAGE) LEAF EXTRACT, ASPARAGUS OFFICINALIS STEM EXTRACT, APIUM GRAVEOLENS (CELERY) EXTRACT, EUTERPE OLERACEA FRUIT EXTRACT, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, FRAGARIA CHILOENSIS (STRAWBERRY) FRUIT EXTRACT, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE, METHICONE, DIMETHICONE CROSSPOLYMER, SILICA SILYLATE, ASCORBYL TETRAISOPALMITATE, DIMETHICONE/METHICONE COPOLYMER, ARACHIS HYPOGAEA (PEANUT) OIL, RETINYL PALMITATE, ADENOSINE, TRIMETHYLSILOXYSILICATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHERYL ACETATE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

  • PURPOSE

    PURPOSE: Sunscreen

  • WARNINGS

    Warning:
    Skin Cancer/Skin Aging Alert
    Spending time in the sun increases your risk of skin cancer and early skin aging.
    This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • USE

    USE:
    Helps 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

    DIRECTIONS:
    Apply liberally 15 minutes before sun exposure.
    Reapply at least every 2 hours. Sun Protection Measures.
    Spending time in the sun increases your risk of skin cancer and early skin aging.
    To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.
    Wear long-sleeved shirts, pants, hats, and sunglasses.
    Children under 6 months of age: Ask a doctor.

  • Other information

    Other information:
    Protect the product in this container from excessive heat and direct sun.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    VITA WATER DROP CC 
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.15 g  in 30 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.29 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-048-0130 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2014
    Labeler - SKINFOOD CO., LTD. (690324173)
    Registrant - SKINFOOD CO., LTD. (690324173)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINFOOD CO., LTD.690324173manufacture(76214-048)

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