EIGHT HOUR CREAM INTENSIVE DAILY MOISTURIZER FOR FACE SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]

EIGHT HOUR CREAM INTENSIVE DAILY MOISTURIZER FOR FACE SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]
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NDC 67938-0866-1, 67938-0866-2
Set ID f8a442e6-8652-47a8-b3d1-ca454d32d159
Category HUMAN OTC DRUG LABEL
Packager Elizabeth Arden, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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