Label: CLEMATIS MORNING DEW BB 23 NATURAL BEIGE- titanium dioxide, octinoxate, zinc oxide cream

  • 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: Titanium Dioxide 8.12%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 4.00%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Glycerin, Niacinamide, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Sodium Chloride, Iron Oxides(CI77492), Disteardimonium Hectorite, Ozokerite, Trimethylsiloxyphenyl Dimethicone, Hydrogenated Polydecene, Hydrogenated Polyisobutene, Dimethicone/Vinyl Dimethicone Crosspolymer, Cetyl Peg/Ppg-10/1 Dimethicone, Sorbitan Sesquioleate, Iron Oxides(CI77491), Phenoxyethanol, Triethoxycaprylylsilane, Beeswax, Iron Oxides(CI77499), Aluminum Hydroxide, Ethylhexylglycerin, Fragrance, Adenosine, Silica dimethyl silylate, Disodium EDTA

  • 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 MORNING DEW BB 23 NATURAL BEIGE 
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71702-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.06 g  in 50 mL
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.50 g  in 50 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.00 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71702-100-021 in 1 CARTON08/01/2017
    1NDC:71702-100-0150 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 finalpart35208/01/2017
    Labeler - Coshub Co., Ltd. (689846820)
    Registrant - Coshub Co., Ltd. (689846820)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSON Co., Ltd._Osan Plant689847210manufacture(71702-100)
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