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

EAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]
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NDC 63049-105-24
Set ID 462a5f2f-ee05-44fb-9e88-796223a58d87
Category HUMAN OTC DRUG LABEL
Packager European Perfume Works Co.L.L.C
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients:

    Avobenzone  3.0%
    Homosalate  10.0%
    Octocrylene  5.0%
    Octisalate     5.0%
    Oxybenzone 5.0%

  • Purpose

    Sunscreen

  • 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.

  • Uses

    • helps to 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

    Acrylates/C10-30 alkyl acrylate crosspolymer, ascorbyl palmitate, aloe barbadensis leaf juice, butylparaben, C12-15 alkyl benzoate, cetearyl alcohol, carbomer, ceteareth-20, ethylparaben, fragrance, glyceryl stearate SE, glyceryl stearate, hydorxypropyl methylcellulose, isobutylparaben, linalool, methylparaben, propylene glycol, PEG-100 stearate, PEG-60 almond glycerides, phenoxyethanol, propylparaben, rosa moschata seed oil, sodium cetearyl sulfate, sodium hydroxide, tocopheryl acetate, tetrasodium EDTA, water

  • Other Information

    • protect the product from excessive heat and direct sun

  • Questions or comments?

    Call toll free 1-844-875-4176

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    EAD KIDS 
    avobenzone, homosalate, octocrylene, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63049-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.64 g  in 88 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8.80 g  in 88 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.40 g  in 88 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.40 g  in 88 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.40 g  in 88 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63049-105-2488 mL in 1 TUBE; Type 0: Not a Combination Product12/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/21/2014
    Labeler - European Perfume Works Co.L.L.C (851151050)
    Establishment
    NameAddressID/FEIBusiness Operations
    European Perfume Works Co.L.L.C851151050manufacture(63049-105)

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