Label: BANANA BOAT BABY MINERAL ENRICHED SUNSCREEN UVA/UVB PROTECTION BROAD SPECTRUM SPF 50PLUS- homosalate,octisalate,octocrylene,zinc oxide lotion

  • NDC Code(s): 63354-682-13
  • Packager: Edgewell Personal Care Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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  • Active Ingredients

    Homosalate 9.0%, Octisalate 3.0%, Octocrylene 6.0%, Zinc Oxide 7.3%.

  • 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.

    Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

    May stain some fabrics.

    Do not use

    on damaged or broken skin

    When using this product

    keep away from face to avoid breathing it • 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. Hold container 4 to 6 inches from the skin to apply. Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands and then apply to face • Do not apply in windy conditions • Use in a well-ventilated area • Reapply: • after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: Ask a doctor

    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. • wear long-sleeved shirts, pants, hats, and sunglasses

  • Inactive ingredients

    Water, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric, Triglyceride, Butyloctyl Salicylate, Phenoxyethanol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Sodium Citrate.

  • 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®
    baby
    mineral
    enriched
    SUNSCREEN LOTION SPRAY
    UVA/UVB PROTECTION BROAD SPECTRUM SPF 50+
    50+
    PEDIATRICIAN TESTED
    Won't Run Into Eyes
    Water Resistant
    (80 Minutes)
    FREE FROM
    Oxybenzone
    Octinoxate
    SHAKE WELL
    BEFORE USE
    NET WT 5 FL OZ
    (147mL)

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT BABY MINERAL ENRICHED SUNSCREEN UVA/UVB PROTECTION BROAD SPECTRUM SPF 50PLUS 
    homosalate,octisalate,octocrylene,zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-682
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ISODODECANE (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-682-13147 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2021
    Labeler - Edgewell Personal Care Brands LLC (151179769)
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