Label: ELIZABETH ARDEN MOISTURE SHIELD SPF 15- octinoxate lotion

  • 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 August 3, 2011

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  • DESCRIPTION

    This lightweight, moisturizing lotion provides the ideal level of hydration as it shields skin from the damaging effects of UV rays. Skin feels restored and rebalanced, and looks healthy and glowing.

  • INDICATIONS AND USAGE

    To Use: Smooth on to face 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 6.25% W/W, Octisalate 5.00% W/W, Oxybenzone 2.00% W/W, Avobenzone 1.50% W/W.

  • INACTIVE INGREDIENT

    Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Isostearyl Neopentanoate, Hydrogenated Polyisobutene, Glycerin, Phenyl Trimethicone, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Petrolatum, PEG-8, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter) Extract, Phospholipids, Pentaerythrityl Tetraethylhexanoate, Cucumis Sativus (Cucumber) Juice, Lycium Chinese Fruit Extract, Panax Ginseng Root Extract, Salvia Officinalis (Sage) Leaf Extract, Vanilla Tahitensis Fruit Extract, Sodium Hyaluronate, Lactic Acid, Tocopheryl Acetate, Arginine, Carnosine, Glycine, Lysine, Proline, Propylene Glycol, Sodium PCA, Trehalose, Urea, Hydrogenated Lecithin, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cetearyl Alcohol, Stearic Acid, Polyquaternium-51, Ethoxydiglycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Xanthan Gum, Citric Acid, Triethanolamine, Sodium Sulfite, Disodium EDTA, Hydroxypropyl Starch Phosphate, Dimethiconol, Parfum/Fragrance, Butylene Methylpropional, Limonene, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Potassium Sorbate, Propylparaben, Sodium Benzoate, Chlorphensin.

  • 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

    MoistureShieldBottle
  • INGREDIENTS AND APPEARANCE
    ELIZABETH ARDEN MOISTURE SHIELD SPF 15 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.125 mL  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 mL  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1 mL  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.75 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CUCUMBER JUICE (UNII: 61845009SP)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ARGININE (UNII: 94ZLA3W45F)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    GLYCINE (UNII: TE7660XO1C)  
    LYSINE (UNII: K3Z4F929H6)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TREHALOSE (UNII: B8WCK70T7I)  
    UREA (UNII: 8W8T17847W)  
    SUCROSE (UNII: C151H8M554)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0801-11 in 1 BOX
    1NDC:67938-0801-250 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/26/2006
    Labeler - Elizabeth Arden, Inc (849222187)