Label: VISIBLE DIFFERENCE SKIN BALANCING SUNSCREEN SPF 15- octinoxate and oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 1, 2013

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  • DESCRIPTION

    This lightweight, oil-free lotion for combination skin leaves skin feeling healthy and balanced with a radiant appearance.

  • 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. Children under 6 months: Ask a doctor.


  • WARNINGS

    Warnings:

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    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 6.0 %, Oxybenzone 3.0 %

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water/Aqua/Eau, Dimethicone, Isononyl Isononanoate, Glycerin, Tridecyl Salicylate, Steareth-21, Isostearic Acid, Octyldodecyl Neopentanoate, Aluminum Starch Octenylsuccinate, Salvia Officinalis (Sage) Leaf Extract, Hydrolyzed Glycosaminoglycans, Sodium Hyaluronate, Sodium Lactate, Retinyl Linoleate, Tetrahexyldecyl Ascorbate, Tocopherol, Glyceryl Stearate, Propylene Glycol, Panthenol, C12-20 Acid PEG-8 Ester, Cetyl Alcohol, PEG-100 Stearate, Trilaureth-4 Phosphate, Steareth-2 Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylene/VA Copolymer, Sclerotium Gum, Triethanolamine, BHT, Disodium EDTA, Parfum/Fragrance, Benxyl Salicylate, Butylphenyl Methylpropional, Citronellol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, DMDM Hydantoin, Methylparaben, Phenoxyethanol, Propylparaben.

  • DOSAGE & ADMINISTRATION

    Smooth on to face.

  • 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.

  • OTC - WHEN USING

    Keep out of eyes.

  • PRINCIPAL DISPLAY PANEL

    VDSBL-CARTON

    VDSBL-ONSERT

    VDSBL-TUBE

     

  • INGREDIENTS AND APPEARANCE
    VISIBLE DIFFERENCE SKIN BALANCING SUNSCREEN SPF 15 
    octinoxate and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    STEARETH-21 (UNII: 53J3F32P58)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    SAGE (UNII: 065C5D077J)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    RETINYL LINOLEATE (UNII: 61911N8D6W)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    STEARETH-2 (UNII: V56DFE46J5)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-1000-11 in 1 CARTON
    1NDC:67938-1000-250 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/16/2011
    Labeler - Elizabeth Arden, Inc (849222187)
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