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

BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE LLC]
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NDC 63354-051-11, 63354-051-14, 63354-051-16, 63354-051-17, 63354-051-18
Set ID 521b8ef2-35f8-43e4-9d7b-67eba99544bf
Category HUMAN OTC DRUG LABEL
Packager Edgewell Personal Care LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Titanium Dioxide 3.1%
    Zinc Oxide 4.0%

  • 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 broken or damaged skin.

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • 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 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

    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
  • Questions or Comments?

    Call 1-800-SafeSun, Mon-Fri

  • Principal Display Panel

    Banana Boat

    Kids

    Tear Free Sting Free

    UVA/UVB Protection

    Sunscreen Lotion

    50

    Broad Spectrum SPF 50

    Pediatrician Tested

    Fragrance Free

    Water Resistant (80 minutes)

    Recommended

    Skin Cancer Foundation

    Active

    Recommended as an effective UV sunscreen

    Swim Splash Sport

    8 FL. OZ. (236 mL)

    Banana Boat

    Kids

    Tear Free Sting Free

    UVA/UVB Protection

    Sunscreen Lotion

    50

    Broad Spectrum SPF 50

    Pediatrician Tested

    Fragrance Free

    Water Resistant (80 minutes)

    Recommended

    Skin Cancer Foundation

    Active

    Recommended as an effective UV sunscreen

    Swim Splash Sport

    2 FL. OZ. (59 mL)

    Bonus 25% More

    Banana Boat

    Kids

    Tear Free Sting Free

    UVA/UVB Protection

    Sunscreen Lotion

    50

    Broad Spectrum SPF 50

    Pediatrician Tested

    Fragrance Free

    Water Resistant (80 minutes)

    Recommended

    Skin Cancer Foundation

    Active

    Recommended as an effective UV sunscreen

    Swim Splash Sport

    10 FL. OZ. (295 mL)

    Banana Boat

    Kids

    Tear Free Sting Free

    UVA/UVB Protection

    Sunscreen Lotion

    50

    Broad Spectrum SPF 50

    Pediatrician Tested

    Fragrance Free

    Water Resistant (80 minutes)

    Recommended

    Skin Cancer Foundation

    Active

    Recommended as an effective UV sunscreen

    Swim Splash Sport

    6 FL. OZ. (177 mL)

    55% More Family Size!

    Banana Boat

    Kids

    Tear Free Sting Free

    UVA/UVB Protection

    Sunscreen Lotion

    50

    Broad Spectrum SPF 50

    Pediatrician Tested

    Fragrance Free

    Water Resistant (80 minutes)

    Recommended

    Skin Cancer Foundation

    Active

    Recommended as an effective UV sunscreen

    Swim Splash Sport

    12 FL. OZ. (354 mL)

    BB Kids 50 2 oz

    BB Kids 50 6 oz

    BB Kids 50 8 oz

    BB Kids 50 10 oz

    BB Kids 50 12 oz

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.1 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:63354-051-16245 g in 1 TUBE; Type 0: Not a Combination Product10/04/2012
    2NDC:63354-051-1161 g in 1 TUBE; Type 0: Not a Combination Product10/04/2012
    3NDC:63354-051-17306 g in 1 TUBE; Type 0: Not a Combination Product10/04/2012
    4NDC:63354-051-14184 g in 1 TUBE; Type 0: Not a Combination Product10/04/2012
    5NDC:63354-051-18368 g in 1 TUBE; Type 0: Not a Combination Product10/04/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/04/2012
    Labeler - Edgewell Personal Care LLC (151179769)

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