EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO. L.L.C]

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EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO. L.L.C]
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NDC 63049-103-23, 63049-103-25
Set ID 950f2653-12ca-4b17-9665-8c99d7acc70c
Category HUMAN OTC DRUG LABEL
Packager European Perfume Works Co. L.L.C
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredients

    Avobenzone    2.0%

    Homosalate    12.0%

    Octisalate       5.0%

    Octocrylene    2.0%

    Oxybenzone    2.0%

  • Purpose

    Sunscreen

  • Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    • helps prevent Sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply

         - after 80 minutes of swimming or sweating
         - immediately after towel drying
         - at least every 2 hours

    • Sun Protection Measures.

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    - limit time in the sun, especially from 10 a.m. - 2 p.m.
    - wear long-sleeve shirts, pants, hats, and sunglasses

    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    amyl cinnamal, ascorbyl palmitate, benzyl alcohol, butylparaben, C12-15 alkyl benzoate,
    carbomer, ceteareth-20, cetearyl alcohol, ethylparaben, fragrance, glyceryl stearate, glyceryl
    stearate SE, isobutylparaben, linalool, methylparaben, PEG-100 stearate, phenoxyethanol,
    propylene glycol, propylparaben, sodium hydroxide, sodium cetearyl sulfate, tetrasodium
    EDTA, tocopheryl acetate, water.

  • Other Information

    • protect this product from excessive heat and direct sun.
  • Questions or Comments?

    Call toll free 1-844-875-4176 (Mon-Fri 9AM-5PM CST)

  • USA Distributor

    ARION PERFUME & BEAUTY INC,

    SAN ANTONIO, TX - 78212
    U.S.A.

    Manufactured BY

    EUROPEAN PERFUME WORKS CO.LLC

    P.O Box 23121, Sharjah, United Arab Emirates

  • Packaging

    EAD SPF 45

  • INGREDIENTS AND APPEARANCE
    EAD 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63049-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.40 g  in 120 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE14.40 g  in 120 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE6.00 g  in 120 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.40 g  in 120 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.40 g  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63049-103-23120 mL in 1 TUBE; Type 0: Not a Combination Product03/18/2014
    2NDC:63049-103-2595 mL in 1 TUBE; Type 0: Not a Combination Product11/12/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/18/2014
    Labeler - European Perfume Works Co. L.L.C (851151050)
    Establishment
    NameAddressID/FEIBusiness Operations
    European Perfume Works Co. L.L.C851151050manufacture(63049-103)
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