Label: CERAMIDE TIME COMPLEX MOISTURE CREAM SPF 15- octinoxate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 1, 2011

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  • DESCRIPTION

    The continuous-release super-moisturizer that helps combat visible signs of aging, as it protects skin from damaging sun exposure: Boosts skin's hydration level over 450% after one hour. Helps provide all-day (up to 15 hours) skin-essential moisture. Relieves dryness. Softens the appearance of fine lines and wrinkles. Exclusively formulated with: Skin-identical Ceramides to help reinforce skin's protective barrier and prevent vital moisture loss. An effective combination of age-fighting ingredients including HCA, our advanced alpha-hydroxy complex.

  • INDICATIONS & USAGE

    To Use: Smooth on to cleansed face and throat before sun exposure.

  • WARNINGS

    Warning: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor. Keep out of reach of children.

  • OTC - ACTIVE INGREDIENT

    Active Ingredient: Octinoxate 6% w/w.

  • INACTIVE INGREDIENT

    Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Cetyl Ethylhexanoate, Sodium Chloride, Butylene Glycol, Glycerin, Squalene, Aluminum Distearate, Cetyl Dimethicone Urea, Ceramide 1, Ceramide 3, Algae Extract, Hydrolyzed Oat Flour, Yeast Extract/Faex/Extrait de Levure, Sodium Hyaluronate, Hydroxycaprylic Acid, Sodium Lactate, Ascorbyl Plamitate, Tocopheryl Acetate, Glycine, Serine, Propylene Glycol, Sodium PCA, Cetyl PEG/PPG-10/1 Dimethicone, Beta-Glucan, Disodium Edta, Aluminum Citrate, Cyclohexasiloxane, Dimethicone Copolyol, Parfum/Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Betylpheny Methylpropional, Citral Citronellol, Geraniol, Hexyl Cinnamal, Hydroxyisohexyl 3-Cyclohexen, Carboxaldehyde, Limonene, Linalool, Methylparaben, Propylparaben.

  • DOSAGE & ADMINISTRATION

    Smooth on to face and throat.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTC - PURPOSE

    Provides SPF 15 sun protection.

  • OTC - WHEN USING

    Avoid contact with eyes.

  • PRINCIPAL DISPLAY PANEL

    Ceramide Time Complex Moisture Cream Box

     Ceramide Time Complex Moisture Cream Tube


  • INGREDIENTS AND APPEARANCE
    CERAMIDE TIME COMPLEX MOISTURE CREAM SPF 15 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0732
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALENE (UNII: 7QWM220FJH)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    UREA (UNII: 8W8T17847W)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    GLYCINE (UNII: TE7660XO1C)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SERINE (UNII: 452VLY9402)  
    OAT BRAN (UNII: KQX236OK4U)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0732-11 in 1 BOX
    1NDC:67938-0732-250 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/27/2007
    Labeler - Elizabeth Arden, Inc (849222187)