MY SUNNY WATERY SUN ESSENCE (OCTINOXATE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [TONYMOLY CO.,LTD]

MY SUNNY WATERY SUN ESSENCE (OCTINOXATE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [TONYMOLY CO.,LTD]
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NDC 59078-324-01, 59078-324-02
Set ID beb83bc1-409b-4899-ad54-568a910da594
Category HUMAN OTC DRUG LABEL
Packager TONYMOLY CO.,LTD
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: ETHYLHEXYL METHOXYCINNAMATE 6.80%, HOMOSALATE 6.00%, ETHYLHEXYL SALICYLATE 4.50%, OCTOCRYLENE 2.50%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Butylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Polymethyl Methacrylate, 1,2-Hexanediol, Cyclopentasiloxane, Propanediol, Phenoxyethanol, Octyldodecanol, Saccharide Hydrolysate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Fragrance, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Carbomer, Tromethamine, Polyacrylate Crosspolymer-6, Echium Plantagineum Seed Oil, Isohexadecane, Portulaca Oleracea Extract, Curcuma Longa (Turmeric) Root Extract, Centella Asiatica Extract, Salvia Hispanica Seed Extract, Sodium Hyaluronate, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Ethylhexylglycerin, t-Butyl Alcohol, Soluble Collagen, Xanthan Gum, Glycyrrhiza Glabra (Licorice) Root Extract, Aloe Barbadensis Leaf Juice, Paeonia Lactiflora Root Extract, Cnidium Officinale Root Extract, Pueraria Thunbergiana Root Extract, Tocopherol, Silica, Hydrolyzed Hyaluronic Acid, Glyceryl Caprylate, Niacinamide, Sodium Starch Octenylsuccinate, Calcium Pantothenate, Maltodextrin, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Pyridoxine HCL, Nymphaba Alba Flower Extract

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    For external use only Do not use on damaged or broken skin 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: Helps prevent sunburn

    Directions: Apply liberally 15 minutes before sun exposure - Reapply at least every 2 hours - Children under 6 months: Ask a doctor

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MY SUNNY WATERY SUN ESSENCE 
    octinoxate, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-324
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.4 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.0 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.25 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-324-021 in 1 CARTON06/01/2017
    1NDC:59078-324-0150 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 finalpart35206/01/2017
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798relabel(59078-324)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(59078-324)

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