VISIBLE DIFFERENCE GENTLE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 15 (OCTINOXATE, AVOBENZONE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]

VISIBLE DIFFERENCE GENTLE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 15 (OCTINOXATE, AVOBENZONE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]
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NDC 67938-1169-1, 67938-1169-2
Set ID e8afa7d0-b25e-42ac-9eaa-81d6ad73b790
Category HUMAN OTC DRUG LABEL
Packager Elizabeth Arden, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • DESCRIPTION

    This multi-benefit moisturizer for dry skin provides intense hydration. Leaves skin feeling soft and smooth.

  • INDICATIONS AND USAGE

    To Use: Smooth onto cleansed face and throat.

    Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection hats, and sunglasses.

    Children under 6 months ask a doctor.

  • WARNINGS

    Warnings: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

  • OTC - ACTIVE INGREDIENT

    Active Ingredients: Octinoxate 7.5%, Avobenzone 3.0%, Oxybenzone 3.0%.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water/Aqua/Eau, Butylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Cetearyl Glucoside, Pentylene Glycol, Butyl Stearate, Tridecyl Salicylate, Cetyl Ricinoleate, Cyclopentasiloxane, Narcissus Tazetta Bulb Extrat, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, Caprylyl Glycol, Cetearyl Dimethicone Crosspolymer, Ethylhexyl Palmitate, Glyceryl Stearate, Sodium PCA, Trehalose, Urea, Hyrdolyzed Soy Protein, Lecithin, Phospholipids, Polyphophorylcholine Glycol Acrylate, Ammonium Acryloyldimethylaurate/VP Coplymer, PEG-100 Stearate, PEG-8 Laurate, PEG-60 Hydrogenated Castor Oil, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, Styrene/Acrylates Copolymer, Hexylene Glycol, Isododecane, PEG-8, Xanthan Gum, Nylon-12, BHT, Disodium EDTA, Mica, Tin Oxide, Silica Dimethyl Silylate, Parfum/Fragrance, Benzyl Salicylate, Butylphenyl Methylpropional, Citonellol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limnene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Chlorphenesin, Titanium Dioxide (CI 77891).

  • DOSAGE AND ADMINISTRATION

    Smooth on to face and throat.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • OTC - PURPOSE

    Provides SPF 15 Sun Protection.

  • WHEN USING

    Keep out of eyes.

  • PRINCIPAL DISPLAY PANEL

    VDGHCCarton

    VDGHCOnsert

    VDGHCJar

    VDGHCBaseLabel

  • INGREDIENTS AND APPEARANCE
    VISIBLE DIFFERENCE GENTLE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 15 
    octinoxate, avobenzone, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1169
    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)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYL STEARATE (UNII: 6Y0AI5605C)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    CETYL RICINOLEATE (UNII: 1P677500YD)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    NARCISSUS TAZETTA BULB (UNII: K17762966S)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TREHALOSE (UNII: B8WCK70T7I)  
    UREA (UNII: 8W8T17847W)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ISODODECANE (UNII: A8289P68Y2)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    NYLON-12 (UNII: 446U8J075B)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MICA (UNII: V8A1AW0880)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBIC ACID (UNII: X045WJ989B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-1169-11 in 1 CARTON
    1NDC:67938-1169-250 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/15/2011
    Labeler - Elizabeth Arden, Inc (849222187)

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