BANANA BOAT (OCTINOXATE, PADIMATE O) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]

BANANA BOAT (OCTINOXATE, PADIMATE O) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]
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NDC 63354-031-16
Set ID 686a934d-2810-4ed1-97c3-b7cf4b1c92d4
Category HUMAN OTC DRUG LABEL
Packager Edgewell Personal Care Brands LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Octinoxate 2.0%

    Padimate O 1.4%

  • Purpose

    Sunscreen

  • Uses

    helps prevent sunburn

  • Warnings

    For external use only

    Skin Cancer/Skin Aging Alert : Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

  • 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.

    May stain some fabrics

  • Directions

    • apply liberally 15 mins before sun exposure
    • Do not spray directly into face. Spray on hands then apply to face.
    • Reapply: after 80 mins of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months: Ask a doctor
  • Inactive ingredients

    Mineral Oil, Phenoxyethanol, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Butter, Fragrance, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil,Methylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, Aloe Barbadensis Leaf Extract, Zea Mays (Corn) Oil, Musa Sapientum (Banana) Fruit Extract, Retinyl Palmitate,Daucus Carota Sativa (Carrot) Root Extract.

  • 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®

    DEEP TANNING

    SPRAY OIL

    SUNSCREEN SPRAY SPF 4

    4

    WITH COCONUT OIL

    Skin Nourishing Formula

    Water Resistant

    (80 Minutes)

    8 FL.OZ. (236 mL)

    Front label

    Back Label

    BANANA

    BOAT

    deep

    Tanning Oil

    SPRAY SUNSCREEN

    4

    SPF 4

    Blended with carrot and Banana Extracts

    FOR DEEP, LONG-LASTING COLOR

    WATER RESISTANT (80 MINUTES)

    SWIM . SPLASH . SPORT

    6335403116

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    octinoxate, padimate o oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O1.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    CORN OIL (UNII: 8470G57WFM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BANANA (UNII: 4AJZ4765R9)  
    CARROT (UNII: L56Z1JK48B)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-031-16201 g in 1 BOTTLE; Type 0: Not a Combination Product09/28/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/28/2010
    Labeler - Edgewell Personal Care Brands LLC (151179769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Playtex Manufacturing Inc963501502manufacture(63354-031)

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