Label: BANANA BOAT- zinc oxide lotion

  • NDC Code(s): 63354-373-01, 63354-373-23
  • Packager: Edgewell Personal Care Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2024

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  • Active Ingredients

    Zinc Oxide 19.0%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn. If used as directed with other sun Sunscreen protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings

    For external use only.

    May stain some fabric.

    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.

    Keep out of reach of children.

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

  • Directions

    • Shake Well • Apply generously and evenly 15 minutes before sun exposure • Reapply 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 value of 15 or higher and other sun protection measures including: ▪ limit time in the sun, especially from 10 a.m. - 2 p.m.; and ▪ wear long-sleeved shirts, pants, hats, and sunglasses. • Reapply after 80 minutes of swimming or sweating • Reapply immediately after towel drying.

  • Inactive Ingredients

    Water, Isohexadecane, Ethylhexyl Palmitate, Diisopropyl Adipate, Cocos Nucifera (Coconut) Oil, Stearyl/Octyldodecyl Citrate Crosspolymer, Glycerin, Polyhydroxystearic Acid, Silica, Sodium Chloride, Phenoxyethanol, Triethoxycaprylylsilane, Xanthan Gum, Cetyl PEG/PPG‐10/1 Dimethicone, Caprylyl Glycol, Lauryl PEG‐8 Dimethicone, Ethylhexylglycerin, Sodium Citrate, Mica, Tocopheryl Acetate, Titanium Dioxide, Iron Oxides.

  • Other Information

    Protect the product in this container from excessive heat and direct sun

  • Questions or Comments?

    Call 1-800-SafeSun, Mon-Fri

  • Principal Display Panel

    NEW!
    Fast Rub In
    Banana Boat
    mineral
    100% MINERAL BASED SUNSCREEN LOTION
    UVA/UVB BROAD SPECTRUM SPF 50
    50
    BLENDS IN ACROSS SKIN TONES
    FRAGRANCE FREE
    Water Resistant
    (80 minutes)
    5 FL.OZ. (147 mL)

    Label

    NEW!
    Fast Rub In
    Banana Boat
    mineral
    100% MINERAL BASED SUNSCREEN LOTION
    UVA/UVB BROAD SPECTRUM SPF 50
    50
    BLENDS IN ACROSS SKIN TONES
    FRAGRANCE FREE
    Water Resistant
    (80 minutes)
    0.25 FL.OZ. (7.4 mL)

    Front Label

    Back Label

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-373
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-373-23147 g in 1 TUBE; Type 0: Not a Combination Product10/01/2024
    2NDC:63354-373-0174 g in 1 PACKET; Type 0: Not a Combination Product10/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2024
    Labeler - Edgewell Personal Care Brands LLC (151179769)
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