FDA.reportPublic FDA data

Banana Boat

Manufacturer
Edgewell Personal Care Brands LLC | Playtex Manufacturing Inc
Effective date
2020-06-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:27:54

Label at a glance#

ProductBanana Boat
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

•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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 4.5%
ZINC OXIDE 6.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Keep away from face to avoid breathing it. 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

Directions

DOSAGE & ADMINISTRATION SECTION

•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

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene,Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate,Tocopheryl Acetate.

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

25% MORE

VALUE SIZE

tear free

BANANA

BOAT (R)

simply

protect (TM)

KiDS

MINERAL-BASED SUNSCREEN LOTION

50+

25% fewer ingredients*

MADE WITHOUT OXYBENZONE & PARABENS

NO ADDED OILS & FRAGRANCES

BROAD SPECTRUM SPF 50+

WATER RESISTANT (80 MINUTES)

7.5 FL. OZ. (221.8 mL)

63354-924-2663354-924-26

50%

MORE

FAMILY SIZE!

9 OZ VS 6 OZ

BANANA

BOAT®

NEW

LOOK!

simply

protect™

KiDS

MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS*

MADE WITHOUT OXYBENZONE & PARABENS

tear free

No Added Oils & Fragrances

Water Resistant

(80 Minutes)

9 FL. OZ. (270 mL)

X301020201X301020201

BANANA

BOAT®

NEW

LOOK!

simply

protect™

KiDS

MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS*

MADE WITHOUT OXYBENZONE & PARABENS

tear free

No Added Oils & Fragrances

Water Resistant

(80 Minutes)

1 FL. OZ. (29 mL)

X301020301X301020301

BANANA

BOAT®

NEW

LOOK!

simply

protect™

KiDS

MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS*

MADE WITHOUT OXYBENZONE & PARABENS

tear free

No Added Oils & Fragrances

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

X301297200X301297200

Tear free

Banana

Boat

simply

protect

kids

mineral based sunscreen lotion

50+

25% fewer ingredients*

made without oxybenzone & parabens

no added oils & fragrances

broad spectrum spf 50+

water resistant (80 minutes)

63354924216335492421

63354924246335492424

63354924276335492427

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-92463354-924-21, 63354-924-24, 63354-924-27, 63354-924-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
SODIUM CITRATE1Q73Q2JULRIACT
ALUMINUM OXIDELMI26O6933IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
ISOHEXADECANE918X1OUF1EIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT

Source Document#

Source XML

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
0a4b72d9-bac0-4d66-e063-6394a90abfce617dceab-3199-2c4c-e053-2a91aa0a66492023-11-16WarningsExact identifier
spl set id: 617dceab-3199-2c4c-e053-2a91aa0a6649

Reported adverse events (FAERS/openFDA)#

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