Label: MY SUNNY POWDE RY FINISH SUN MILK- titanium dioxide, octinoxate, zinc oxide 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 June 14, 2016

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  • ACTIVE INGREDIENT

    Active ingredient: Titanium Dioxide 4.15%, Ethylhexyl Methoxycinnamate 4.0%, Zinc Oxide 2.88%

  • INACTIVE INGREDIENT

    Inactive Ingredient: Water, Cyclopentasiloxane, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Silica, Bis-PEG/PPG-14/14 Dimethicone, Polymethyl Methacrylate, 4-Methylbenzylidene Camphor, Hexyldecyl Myristoyl Methylaminopropionate, Quaternium-18 Bentonite, Sorbitan Sesquioleate, Tilia Platyphyllos Flower Extract, Anthemis Nobilis Flower Water, Lavandula Angustifolia (Lavender) Flower Water, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Fragrance, Magnesium Sulfate, Codium Tomentosum Extract, Hydrogen Dimethicone, Aloe Barbadensis Leaf Juice, Enteromorpha Compressa Extract, Nymphaea Alba Flower Extract, Sodium Benzoate, Glycerin, Disodium EDTA, Potassium Sorbate, Pseudoalteromonas Ferment Extract, CI 77492, Alcohol, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Ecklonia Cava Extract, Mesembryanthemum Crystallinum Extract, CI 77491, Citric Acid, Sodium Hyaluronate, Ethylhexylglycerin, PVP, Platinum Powder

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only. When using this product do not get into eyes. Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • DESCRIPTION

    Use: Helps prevent and relieve chapped or cracked skin.

    Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MY SUNNY POWDE RY FINISH SUN MILK 
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.86 g  in 45 mL
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.80 g  in 45 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.29 g  in 45 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-309-021 in 1 CARTON05/01/2016
    1NDC:59078-309-0145 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 finalpart35205/01/2016
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798manufacture(59078-309)
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