BANANA BOAT BABY SPF 50 (TITANIUM DIOXIDE,ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]

BANANA BOAT BABY SPF 50 (TITANIUM DIOXIDE,ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]
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NDC 63354-050-21
Set ID 6f76941b-03c0-487c-9456-083d0164db0d
Category HUMAN OTC DRUG LABEL
Packager EDGEWELL PERSONAL CARE BRANDS LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Purpose

    Sunscreen

  • 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.

    Stop use and ask a doctor

    if rash occurs.

    Keep out of reach of children.

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

  • 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 skin 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

    Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl

    Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38

    Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene,

    Dimethicone, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate,

    Aloe Barbadensis Leaf Juice, Phenoxyethanol.

  • Other information

    • protect this product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL

    63354050276334505026

    Tear Free Sting Free

    Banana

    Boat

    baby

    UVA/UVB PROTECTION

    SUNSCREEN LOTION

    50

    BROAD SPECTRUM

    SPF 50

    Proven to be Gentle

    Water Resistant

    (80 minutes)

    SWIM SPLASH SPORT

    2 FL.OZ. (59 mL)

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT BABY SPF 50 
    titanium dioxide,zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.2 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-050-2160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/09/2014
    Labeler - EDGEWELL PERSONAL CARE BRANDS LLC (021718141)

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