Label: MIZON UV SUN PROTECTOR- 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 January 8, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Ethylhexyl Methoxycinnamate 7.35%, Ethylhexyl Salicylate 4.75%, Zinc Oxide 4.30%, Titanium Dioxide 3.60%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethyl Citrate, Sodium Chloride, DIMETHICONE/PEG-10/15 CROSSPOLYMER, Triethoxycaprylylsilane, Sodium Hyaluronate, Biosaccharide Gum-1, Hedera Helix(Ivy) Extract, Ethylhexylglycerin, Caprylyl Glycol, Disteardimonium Hectorite, Brassica Oleracea Italica(Broccoli) Extract, Fragrance, Allantoin, Sodium Citrate, Tropolone, Argania Spinosa Kernel Oil, Dipropylene Glycol, Disodium Edta, Tocopherol

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.

  • DESCRIPTION

    How to use: Apply evenly to areas exposed to UV Rays such as your face and arms and allow it to absorb.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MIZON UV SUN PROTECTOR 
    octinoxate, octisalate, zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.67 g  in 50 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.37 g  in 50 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.15 g  in 50 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.80 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57718-070-0150 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2015
    Labeler - MIZON CO., LTD. (557815570)
    Registrant - MIZON CO., LTD. (557815570)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIZON CO., LTD.557815570repack(57718-070)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coson Co., Ltd.689835593manufacture(57718-070)
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