FDA.reportPublic FDA data

BANANA BOAT

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2020-06-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:27:54

Label at a glance#

ProductBANANA BOAT
Active ingredientAVOBENZONE, OXYBENZONE, OCTOCRYLENE
Label structure14 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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 Pr...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Octocrylene 10%, Oxybenzone 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

Keep away form face to avoid breathing it. Keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if product is swallowed, get medical help or contact a poison control center right away. May stain some fabrics

Flammable

GENERAL PRECAUTIONS SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Alcohol Denat., Isobutane, Isodecyl Neopentanoate, VA/Butyl Malate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Menthyl Lactate, Mineral Oil, Aloe Barbadensis Leaf Extract, Fragrance

Other information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-SafeSun, Mon-Fri

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANANA

BOAT (R)

SPORT

Performance (R)

coolzone(R)

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

INSTANTLY

COOLS &

REFRESHES

LIGHTWEIGHT

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

63354-910-3463354-910-34

CLEAR

Ulramist

BANANA

BOAT

SPORT

Performance

coolzone

Instantly cools & refreshes

UVA/UVB PROTECTION

CONTINUOUS SPRAY SUNSCREEN

50+

BROAD SPECTRUM SPF 50+

Refreshing, Clean Scent!

Invisible Clear Spray

Water Resistant (80 Minutes)

SWIM SPLASH SPORT

63354910346335491034

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-910-342024-01-10C16284748780-1d6a99b39-db0b-a426-e053-dadaa90af4c229156a0b-5010-4481-8ae2-0bd7987e8da7
63354-910-342022-01-28C16284748780-1d6a99b39-db0b-a426-e053-dadaa90af4c229156a0b-5010-4481-8ae2-0bd7987e8da7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
ISOBUTANEINACTIVE INGREDIENTBXR49TP6111
ISODECYL NEOPENTANOATEINACTIVE INGREDIENTW60VYE24XC1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7I1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-91063354-910-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OXYBENZONE95OOS7VE0YACTIB
ISODECYL NEOPENTANOATEW60VYE24XCIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
MINERAL OILT5L8T28FGPIACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOBUTANEBXR49TP611IACT
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 93 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, FOAM / TOPICAL18 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, SPRAY / TOPICAL4484 mgExact identifier — unii candidate
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e9e6a57-0c62-075f-e063-6394a90a883a29156a0b-5010-4481-8ae2-0bd7987e8da72024-01-10WarningsExact identifier
spl set id: 29156a0b-5010-4481-8ae2-0bd7987e8da7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.