Label: CLEMATIS BASE CUSHION- octinoxate, titanium dioxide, octisalate, zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 September 4, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Ethylhexyl Methoxycinnamate 7.50%, Titanium Dioxide 6.05%, Ethylhexyl Salicylate 5.00%, Zinc Oxide 1.96%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Butylene Glycol, Glycerin, Niacinamide, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone,PEG-10 Dimethicone, Aluminum Hydroxide, Magnesium Sulfate, Stearic Acid, Disteardimonium Hectorite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Polyhydroxystearic Acid , Caprylyl Glycol, Methyl Methacrylate Crosspolymer, Allantoin, Tocopheryl Acetate, Lecithin, Ethylhexyl Palmitate, Isostearic Acid, Isopropyl Myristate, Iron Oxides (CI 77491), Caprylhydroxamic Acid, Triethoxycaprylylsilane, Adenosine, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Biosaccharide Gum-1, Sophora Japonica Fruit Extract, Pancratium Maritimum Extract, Fragrance

  • 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.

  • DESCRIPTION

    Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

    Directions: Gently press the pull on the air cushion and pat it onto your skin

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CLEMATIS BASE CUSHION 
    octinoxate, titanium dioxide, octisalate, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71702-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.97 g  in 13 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.78 g  in 13 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.65 g  in 13 g
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.25 g  in 13 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71702-010-021 in 1 CARTON08/01/2017
    1NDC:71702-010-0113 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 finalpart35208/01/2017
    Labeler - Coshub Co., Ltd. (689846820)
    Registrant - Coshub Co., Ltd. (689846820)
    Establishment
    NameAddressID/FEIBusiness Operations
    EYESOME. Co.,Ltd.557795360manufacture(71702-010)
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