ROOTREE MOBITHERAPY UV SUN SHIELD (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) CREAM [KTCS CORPORATION]

ROOTREE MOBITHERAPY UV SUN SHIELD (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) CREAM [KTCS CORPORATION]
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NDC 72441-070-01, 72441-070-02
Set ID c02c9385-21b8-4d80-bbdc-e1587aca2a51
Category HUMAN OTC DRUG LABEL
Packager KTCS Corporation
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENTS

    Ethylhexyl Methoxycinnamate 7.0%
    Ethylhexyl Salicylate 4.80%
    Titanium Dioxide 2.075%

  • INACTIVE INGREDIENTS

    Water, Butylene Glycol, Glycerin, Dicaprylyl Carbonate, Niacinamide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cyclopentasiloxane, Cyclohexasiloxane, Glyceryl Stearate, Stearic Acid, Potassium Cetyl Phosphate, Arachidyl Alcohol, Polysorbate 60, Dimethicone, PEG-100 Stearate, Polymethyl Methacrylate, Behenyl Alcohol, Dimethicone/ Vinyl Dimethicone Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Caprylyl Glycol, Aluminum Hydroxide, Arachidyl Glucoside, Fragrance, Xanthan Gum, Arginine, Caprylhydroxamic Acid, Carbomer, Adenosine, Sesamum Indicum (Sesame) Sprout Extract, Glycine Soja (Soybean) Sprout Extract, Phaseolus Radiatus Sprout Extract, Lactobacillus Ferment Lysate, Dendropanax Morbifera Extract, Mentha Arvensis Leaf Extract, Brassica Napus Extract, Citrus Sudachi Fruit Juice, Dipotassium Glycyrrhizate, Disodium EDTA, Tocopheryl Acetate, Benzyl Alcohol, Centella Asiatica Extract

  • PURPOSE

    Sunscreen

  • WARNINGS

    - Cease use if problems arise after applying the product and consult a specialist on the symptoms

    - Do not use on the wound

    - Keep the product out of the reach of children and avoid storing in are as exposed to direct sunlight

  • DESCRIPTION

    Uses:

    It is a natural sun-cream product containing the ingredients extracted from Dendropanax Mobifera tree of Jeju. Its natural formulation protects skin from the UV ray A and B which cause skin-aging. It softly embraces skin with long lasting moisture and forwards rich natural moisturizing ingredients to your skin.

    Directions:

    At the last stage of basic skin care, apply the adequate amount on the areas such as face, neck, arms, legs and etc. which can be easily exposed to UV rays.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ROOTREE MOBITHERAPY UV SUN SHIELD 
    octinoxate, octisalate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72441-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate4.2 g  in 60 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.88 g  in 60 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.24 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72441-070-021 in 1 CARTON07/01/2018
    1NDC:72441-070-0160 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2018
    Labeler - KTCS Corporation (688326214)
    Registrant - KTCS Corporation (688326214)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATEC Co., Ltd.689276681manufacture(72441-070)

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