FDA.reportPublic FDA data

BANANA BOAT

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2024-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:01

Label at a glance#

ProductBANANA BOAT
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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.

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 doct...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen Agent

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only.

May stain some fabrics.

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 °F.
Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

• Keep away from 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.

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

Water, Isobutane, Isododecane, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Polyhydroxystearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Triethoxycaprylylsilane, Sodium Citrate.

Other Information

SPL UNCLASSIFIED SECTION

• 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

BANANA BOAT(R)
KiDS
mineral
100% MINERAL BASED SUNSCREEN LOTION SPRAY
UVA/UVB BROAD SPECTRUM SPF 50
50
PEDIATRICIAN TESTED
Won't run into eyes
FREE FROM
Oxybenzone
Octinoxate
Water Resistant
(80 Minutes)
NET WT 5 OZ. (141 g)

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-104-33BANANA BOAT141 g in 1 CANAEROSOL, SPRAY1411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-104BANANA BOAT (ZINC OXIDE) AEROSOL, SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]1Current NDC, 1 package rows20240625_1ba50f16-4b76-825f-e063-6294a90a2a4d.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-10463354-104-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
ISODODECANEA8289P68Y2IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
WATER059QF0KO0RIACT
ISOBUTANEBXR49TP611IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SODIUM CITRATE1Q73Q2JULRIACT
ZINC OXIDESOI2LOH54ZACTIB

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
BANANA BOATZINC OXIDEEdgewell Personal Care Brands LLC1ba50f16-4b76-825f-e063-6294a90a2a4d2024-06-24WarningsExact identifier
ndc (package): 63354-104-33
ndc (product): 63354-104
ndc11 (package): 63354010433
spl id: 1ba51cb0-8ed0-e46d-e063-6394a90a0e90
spl set id: 1ba50f16-4b76-825f-e063-6294a90a2a4d

Reported adverse events (FAERS/openFDA)#

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