CALIFORNIA ALOE WATERPROOF SUN BLOCK (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [NATURE REPUBLIC CO., LTD.]

CALIFORNIA ALOE WATERPROOF SUN BLOCK (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [NATURE REPUBLIC CO., LTD.]
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NDC 51346-518-01, 51346-518-02
Set ID 5469dc17-abc9-43c2-8ea6-5224cedf5b6c
Category HUMAN OTC DRUG LABEL
Packager NATURE REPUBLIC CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients: Zinc Oxide 9.7%, Titanium Dioxide 5.95%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, GLYCERIN, BUTYLENE GLYCOL, ETHYLHEXYL PALMITATE, CYCLOPENTASILOXANE, ACRYLATES COPOLYMER, NEOPENTYL GLYCOL DIHEPTANOATE, NIACINAMIDE, PROPANEDIOL, CYCLOHEXASILOXANE, POLYMETHYLSILSESQUIOXANE, CAPRYLYL METHICONE, DIMENTHICONE, CETEARYL ALCOHOL, TRICETEARETH-4 PHOSPHATE, GLYCERYL STEARATE, PEG-100 STEARATE, GLYCOL STEARATE, SILICA, PEG-2 STEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN SESQUIOLEATE, PHENOXYETHANOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, FRAGANCE(PARFUM), TROMETHAMINE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, SEA WATER, ADENOSINE, XANTHAN GUM, IRON OXIDES(CI 774692), DISODIUM EDTA, IRON OXIDES(CI 77491), HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, TRIETHOXYCAPRYLYSILANE, MORINDA CITRIFOLIA FRUIT EXTRACT, LEUCONOSTOC/RADISH ROOTH FERMENT FILTRATE, ALOE BARBADENSIS LEAF EXTRACT, PENTYLENE GLYCOL, SODIUM BENZOATE, CITRIC ACID, 1,2-HEXANEDIOL, POLYQUATERNIUM-51

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

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

  • DESCRIPTION

    Uses:
    UV Protection.
    Long-lasting strong waterproof sunblock, resistant to water and sweat.

    Directions:
    Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CALIFORNIA ALOE WATERPROOF SUN BLOCK 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-518
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.82 g  in 60 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.57 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51346-518-021 in 1 CARTON12/01/2018
    1NDC:51346-518-0160 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(51346-518)

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