BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]

BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]
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NDC 63354-220-34
Set ID 6598bbb7-689e-49f3-a570-d6274ca4a60e
Category HUMAN OTC DRUG LABEL
Packager Edgewell Personal Care Brands LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Avobenzone 3.0%
    Homosalate 5.0%
    Octocrylene 4.0%
    Oxybenzone 3.0%

  • 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.

    Flammable: Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 oF. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    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.

    May stain some fabrics.

  • Directions

    • 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 then apply to face
    • do not apply in windy conditions
    • use in well-ventilated area
    • 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

    Alcohol Denat., Mineral Oil, C12-15 Alkyl Lactate, Ethylhexyl Benzoate, Trimethylolpropane Tricaprylate/Tricaprate, Acrylates/Octylacrylamide Copolymer, Cetearyl Ethylhexanoate, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Caprylyl Glycol, Dimethyl Capramide, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Fragrance.

  • Other Information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    Call 1-800-SafeSun, Mon-Fri

  • Principle Display Panel

    BANANA BOAT

    protective

    Dry Oil

    UVA/UVB PROTECTION

    CONTINUOUS SPRAY SUNSCREEN

    25

    BROAD SPECTRUM

    SPF 25

    COCONUT & GRAPE SEED OIL

    FAST & EVEN COVERAGE

    WATER RESISTANT (80 MINUTES)

    SWIM SPLASH SPORT

    6 FL. OZ. (177 mL)

    BB DRY OIL 25

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone, homosalate, octocrylene, oxybenzone oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)  
    TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-220-34177 g in 1 BOTTLE; Type 0: Not a Combination Product11/19/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/19/2012
    Labeler - Edgewell Personal Care Brands LLC (151179769)

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