Label: INTERVENE RADIANCE BOOSTING MOISTURE 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 January 13, 2011

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  • DESCRIPTION

    This multi-benefit moisturizer immediately boosts skin's appearance for a radiant, clearn, natural looking glow. With continued use, naturally-derived Biodormin technology supports skin's natural cell metabolism rate to help fight the visible aging effects caused by stress. Helps minimize the look of fine lines and combat the appearance of new ones. Provides deep hydration so skin stays younger looking longer. Clinically, dermatologist and allergy tested.

  • INDICATIONS AND USAGE

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

  • WARNINGS

    Warning: For extrenal used 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 7.5% w/w, Avobenzone 3.0% w/w, Oxybenzone 3.0% w/w.

  • INACTIVE INGREDIENT

    Other Ingredients: Water/Aqua/Eau, Ethylhexyl Methoxycinnamate, Glycerin, Butylene Glycol, Isononyl Isononanoate, Dimethicone, Cetearyl Glucoside, Benzophenone-3, Butyl Methoxydibenzoylmethane, Pentylene Glycol, Butyl Stearate, Tidecyl Salicylate, Cetyl Ricinoleate, Cyclopentasiloxane, Narcissus Tazetta Bulb Extract, Triolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Tocopherold, Tocopheryl Acetate, Caprylyl Glycol, Cetearyl Dimethicone Crosspolymer, Ethylhexyl Palmitate, Glyceryl Stearate, Sodium PCA, Trehalose, Urea, Hydrolyzed Soy Protein, Lecithin, Palmitoyl Tetrapeptide-7, Phospholipids, Polyphosphorylcholine Glycol Acrylate, Ammonium Acryloyldimethyltaurate/VP Copolymer, PEG-100 Stearate, PEG-8 Laurate, Steareth-20, PEG-60 Hydrogenated Castor Oil, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, Styrene/Acrylates Copolymer, Hexylene Glycol, Isododecane, PEG-8, Zanthan Gum, Nylon-12, Disodium EDTA, Mica, Tin Oxide, Silica Dimethyl Silylate, Parfum/Fragrance, Butylphenyl Methylpropional, Citronellol, Limonene, Linalool, Benzoic Acid, Methylparaben, Phenoxyethanol, Postassium Sorbate, Propylparaben, Sorbic Acid, Chlorhexidine Digluconate, Chlorphenesin, Titanium Dioxide (CI 77891).

  • 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

    Intrevene Radiance Boosting Moisture Cream Carton

    Intervene Radiance Boosting Moisture Cream Bottom Label

  • INGREDIENTS AND APPEARANCE
    INTERVENE RADIANCE BOOSTING MOISTURE SPF 15 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYL STEARATE (UNII: 6Y0AI5605C)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    UREA (UNII: 8W8T17847W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    NARCISSUS TAZETTA BULB (UNII: K17762966S)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TREHALOSE (UNII: B8WCK70T7I)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    SORBIC ACID (UNII: X045WJ989B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-1044-11 in 1 BOX
    1NDC:67938-1044-250 g in 1 JAR
    2NDC:67938-1044-31 in 1 BOX
    2NDC:67938-1044-415 g in 1 TUBE
    3NDC:67938-1044-51 in 1 BOX
    3NDC:67938-1044-67 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/27/2009
    Labeler - Elizabeth Arden, Inc (849222187)