BANANA BOAT (HOMOSALATE, OCTINOXATE, OCTOCRYLENE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]

BANANA BOAT (HOMOSALATE, OCTINOXATE, OCTOCRYLENE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]
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NDC 63354-917-21, 63354-917-24, 63354-917-27
Set ID 61d11aaf-0ab3-bfdd-e053-2a91aa0a4cd0
Category HUMAN OTC DRUG LABEL
Packager Edgewell Personal Care Brands LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    HOMOSALATE 9%, OCTINOXATE 1%, OCTOCRYLENE 6%, ZINC OXIDE 7.3%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    For external use only

    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.

  • Do not use

    on damaged or broken skin

  • When using this product

    keep out of eyes. Keep away from face to avoid breathing it. 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 •Children under 6 months: Ask a doctor

  • Inactive Ingredients

    Water, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Glycerin, Polyglyceryl-3 Methylglucose Distearate, Dimethicone, VP/Eicosene Copolymer, Phenoxyethanol, Xanthan Gum, Glyceryl Stearate, PEG-100 Stearate, Polyhydroxystearic Acid, Chlorphenesin, Beeswax, Triethoxycaprylylsilane, Disodium EDTA.

  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions or Comments?

    Call 1-800-SAFESUN, Mon-Fri

  • Principal Display Panel

    NEW!

    25% MORE

    VALUE SIZE

    water &

    sweat resistant

    (80 MINUTES)

    BANANA

    BOAT (R)

    simply

    protect (TM)

    SPORT

    SUNSCREEN LOTION

    50+

    25% fewer ingredients*

    MADE WITHOUT OXYBENZONE & PARABENS

    NO ADDED OILS & FRAGRANCES

    BROAD SPECTRUM SPF 50+

    7.5 FL. OZ. (221.8 mL)

    63354-917-26

    BANANA

    BOAT®

    NEW

    LOOK!

    simply

    protect™

    SPORT

    MINERAL ENRICHED SUNSCREEN LOTION

    UVA/UVB BROAD SPECTRUM SPF 50+

    50+

    25% FEWER INGREDIENTS*

    MADE WITHOUT OXYBENZONE & PARABENS

    HIGH ENDURANCE VS. SWEAT

    No Added Oils & Fragrances

    Water Resistant

    (80 Minutes)

    6 FL. OZ. (177 mL)

    X301297100

    50%

    MORE

    FAMILY SIZE!

    9 OZ VS 6 OZ

    BANANA

    BOAT®

    NEW

    LOOK!

    simply

    protect™

    SPORT

    MINERAL ENRICHED SUNSCREEN LOTION

    UVA/UVB BROAD SPECTRUM SPF 50+

    50+

    25% FEWER INGREDIENTS*

    MADE WITHOUT OXYBENZONE & PARABENS

    HIGH ENDURANCE VS. SWEAT

    No Added Oils & Fragrances

    Water Resistant

    (80 Minutes)

    9 FL. OZ. (270 mL)

    X301100801

    water &

    sweat resistant

    (80 minutes)

    Banana

    Boat

    simply

    protect

    Sport

    sunscreen lotion

    50+

    25% fewer ingredients*

    made without oxybenzone & parabens

    no added oils & fragrances

    broad spectrum SPF 50+

    6335491721

    6335491724

    6335491727

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    homosalate, octinoxate, octocrylene, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-917
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-917-2129 g in 1 TUBE; Type 0: Not a Combination Product01/02/2018
    2NDC:63354-917-24177 g in 1 TUBE; Type 0: Not a Combination Product01/02/2018
    3NDC:63354-917-27270 g in 1 TUBE; Type 0: Not a Combination Product01/02/2018
    4NDC:63354-917-26213 g in 1 TUBE; Type 0: Not a Combination Product01/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2018
    Labeler - Edgewell Personal Care Brands LLC (151179769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Playtex Manufacturing Inc963501502manufacture(63354-917)

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