Label: CERAMIDE LIFT AND FIRM EYE SUNSCREEN SPF 15- octinoxate and oxybenzone cream

  • 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 April 16, 2013

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  • DESCRIPTION

    An eye moisture treatment to diminish the appearance of fine lines and wrinkles, crow's feet, dark circles, and puffiness. Gently lifts and firms the look of skin in the eye area for a brighter, visibly youthful, and more rested look.

  • INDICATIONS AND USAGE

    To Use: Pat gently to cleansed skin around the eye area.

    For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

  • 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 4.09%, Oxybenzone 1.40%.

  • INACTIVE INGREDIENT

    Othe Ingredients: Water/Aqua/Eau, Dimethicone, Cetyl Ricinoleate, Octinoxate, Cetearyl Alcohol, Glycerin, Synthetic Beeswax, Butylene Glycol, Stearyl Heptanoate, Myristal Myristate, Isononyl Isononanoate, Oxybenzone, Ammonium Acryloyldimethyltaurate/VP Copolymer, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire de Carnauba, PPG-2 Isoceteth-20 Acetate, Ceteth-20, Penoxyethanol, Cyclopentasiloxane, Myristyl Laurate, PEG-100 Stearate, Ascorbyl Glucoside, Beeswax/Cera Alba/Cire d'Abeille, BIS-PEG-12 Dimethicone, PEG-20, Sorbitan Tristearate, Steareth-100, Hibiscus Abelmoschuss Seed Extract, Propylene Glycol, VP/Eicosense Copolymer, BHT, Diazolidnyl Urea, Disodium EDTA, Hesperidin Methyl Chalcone, Sodium Hydroxide, Steareth-20, Pyrus Malus (Apple) Fruit Extract, Camellia Sinensis Leaf Extract, Methylparaben, Sodium Lauroyl Lactylate, Xanthan Gum, Silica, Propylparaben, Glycine Soja (Soybean) Seed Extract, PVP, Ceramide 3, Chlorhexdine Digluconate, Phospholipids, Ceramide 6 II, Dipeptide-2, Phytosphingosine, Potassium Sorbate, Tocopheryl Acetate, Ascorbyl Palmitate, Palmitoyl Tetrapeptide-7, Acetyl Octapeptide-3, Ceramide 1.

  • DOSAGE & ADMINISTRATION

    Pat around eyes.

  • 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 immediately.

  • OTC - PURPOSE

    Provides SPF 15 sun protection.

  • OTC - WHEN USING

    Keep out of eyes.

  • PRINCIPAL DISPLAY PANEL

    LiftandFirmEyeCarton

    LiftandFirmEyeOnsert

    LiftandFirmEyeBaseLabel

  • INGREDIENTS AND APPEARANCE
    CERAMIDE LIFT AND FIRM EYE SUNSCREEN SPF 15 
    octinoxate and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0993
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.58896 g  in 14.4 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.2016 g  in 14.4 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL RICINOLEATE (UNII: 1P677500YD)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)  
    CETETH-20 (UNII: I835H2IHHX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MYRISTYL LAURATE (UNII: 58U0NZN2BT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    APPLE (UNII: B423VGH5S9)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0993-11 in 1 BOX
    1NDC:67938-0993-214.4 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/27/2010
    Labeler - Elizabeth Arden, Inc (849222187)