Label: CERAMIDE EYEWISH EYE SUNSCREEN SPF 10- octinoxate and oxybenzone 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 October 22, 2012

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Ceramide and botanical technology combine in one gentle all-around eye cream. This instantly moisturizing formula reduces the appearance of dark circles and fine lines, promotes firmer looking skin, soothes puffiness, and helps protect against future signs of aging due to sun exposure.

  • INDICATIONS AND USAGE

    To Use: Pat gently all around eye area.

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

    Childre Under 6: 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 show 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 6.00% , Oxybenzone 0.50%.

  • INACTIVE INGREDIENT

    Other Ingredients: Water, Hamamelis Virginiana (Witch Hazel) Water, Dimethicone, Squalene, Butylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Caprylic/Capric/Stearic Triglyceride, Polymethyl Methacrylate, Cetyl Alcohol, Alcohol Denat., Ceramide 3, Ergothioneine, Avena Sativa (Oat) Bran, Centella Asiatica Extract, Cucumin Sativus (Cucumber) Fruit Extract, Echinacea Purpurea Extract, Ginkgo Biloba Leaf Extract, Morus Bombycis Root Extract, Pyrus Malus (Apple) Fruit Extract, Salvia Officinalis (Sage) Leaf Extract, Scutellaria Baicalensis Root Extract, Vitis Vinifera (Grape) Fruit Extratct, Vitin Vinifera (Grape) Seed Extract, Retinyl Linoleate, Tocopherol, Propylene Glycol, Phospholipids, Laureth-7, Beta-Glucan, C13-14 Isoparaffin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylamide, Triethanolamine, BHT, Sodium Metabisulfite, Sodium Sulfite, Disodium EDTA, Diazolidnyl Urea, Methyl Paraben, Phenoxyethanol.

  • DOSAGE & ADMINISTRATION

    Pat around eye area.

  • 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 10 sun protection.

  • OTC - WHEN USING

    Keep out of eyes.

  • PRINCIPAL DISPLAY PANEL

    EyeWish Carton

    EyeWish Onsert

    EyeWish Base Label

  • INGREDIENTS AND APPEARANCE
    CERAMIDE EYEWISH EYE SUNSCREEN SPF 10 
    octinoxate and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0772
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.852 g  in 14.2 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.071 g  in 14.2 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SQUALENE (UNII: 7QWM220FJH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
    WINE GRAPE (UNII: 3GOV20705G)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CUCUMBER (UNII: YY7C30VXJT)  
    RETINYL LINOLEATE (UNII: 61911N8D6W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN)  
    GINKGO (UNII: 19FUJ2C58T)  
    APPLE (UNII: B423VGH5S9)  
    MORUS AUSTRALIS ROOT (UNII: 1VL55O45RF)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    OAT BRAN (UNII: KQX236OK4U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0772-11 in 1 BOX
    1NDC:67938-0772-214.2 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/16/2006
    Labeler - Elizabeth Arden, Inc (849222187)