Label: EIGHT HOUR CREAM INTENSIVE DAILY MOISTURIZER FOR FACE 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 July 27, 2011

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  • DESCRIPTION

    This daily hydrating lotion leaves skin feeling soft, smooth, and moisturized for up to 8 hours. Protects skin from the effects of extreme weather and climate changes while SPF 15 shields from the harmful effects of the sun.

  • INDICATIONS AND USAGE

    To Use: Smooth on to cleansed face and throat daily 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 Ingredients: Octinoxate 6.0% W/W, Oxybenzone 3.0% W/W, Avobenzone 2.0% W/W.

  • INACTIVE INGREDIENT

    Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Glycerin, Dimethicone, Butyloctyl Salicylate, Steareth-2, Methylheptyl Isostearate, Butyrospermum Parkii (Shea Butter), Petrolatum, Cetearyl Glucoside, Aluminum Starch Octenylsuccinate, Butylene Glycol, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Tocopheryl Acetate, Sodium PCA, Trehalose, Urea, Allantoin, C10-30 Cholesterol/Lanosterol Esters, Panthenonl, Phospholipids, Stearyl Alcohol, PEG/PPG-20/15 Dimethicone, Seareth-21, Polyquaternium-51, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polethylene, Triethanolamine, Disodium EDTA, Dimethicone Crosspolymer Phenyl Methicone, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Benzoic Acid, Methyparaben, Phenoxyethanol, Chlorphenesin.

  • DOSAGE & ADMINISTRATION

    Smooth on to face.

  • 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

    8HrIntenseFaceBox

    8HrIntenseFaceTube

  • INGREDIENTS AND APPEARANCE
    EIGHT HOUR CREAM INTENSIVE DAILY MOISTURIZER FOR FACE SPF 15 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0866
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.94 g  in 49 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.47 g  in 49 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.98 g  in 49 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    STEARETH-2 (UNII: V56DFE46J5)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TREHALOSE (UNII: B8WCK70T7I)  
    UREA (UNII: 8W8T17847W)  
    ALLANTOIN (UNII: 344S277G0Z)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CITRAL (UNII: T7EU0O9VPP)  
    GERANIOL (UNII: L837108USY)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0866-11 in 1 BOX
    1NDC:67938-0866-249 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/06/2008
    Labeler - Elizabeth Arden, Inc (849222187)
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