Label: CLEMATIS HYDRO PROTECTIVE UV SUN ESSENCE- octinoxate, homosalate, octisalate gel

  • 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 5, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Homosalate 6.00%, Ethylhexyl Salicylate 4.50%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Glycerin, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Alcohol, Niacinamide, Polymethyl Methacrylate, Polymethylsilsesquioxane, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Phenoxyethanol, Fragrance, Fructooligosaccharides, Saccharide Hydrolysate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Propanediol, Pullulan, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Adenosine, Butylene Glycol, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sambucus Nigra Flower Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Magnolia Liliflora Flower Extract, Plumeria Rubra Flower Extract, Lilium Tigrinum Extract, Glyceryl Stearate, Dimethicone, Carbomer, Polyglyceryl-3 Methylglucose Distearate, Polysorbate 20, Polyacrylate Crosspolymer-6, Titanium Dioxide (CI77891), C12-15 Alkyl Benzoate, Tocopherol, Polyglyceryl-2 Caprate, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, t-Butyl Alcohol, Stearic Acid, Glyceryl Caprylate, Squalane

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Replace the cap after use. 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: Apply the sun gel liberally to cover all parts of your face and body exposed to the sun's rays.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CLEMATIS HYDRO PROTECTIVE UV SUN ESSENCE 
    octinoxate, homosalate, octisalate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71702-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.50 g  in 50 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate3.00 g  in 50 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.25 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71702-060-021 in 1 CARTON08/01/2017
    1NDC:71702-060-0150 mL 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
    COSON Co., Ltd._Osan Plant689847210manufacture(71702-060)