FDA.reportPublic FDA data

BANANA BOAT

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2023-10-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:56:23

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

• apply liberally 15 minutes before sun exposure • 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 value of 15 or higher and other sun protection measures including: • limit...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 23.8%

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.

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. 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

• apply liberally 15 minutes before sun exposure • 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 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 • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Ozokerite, Butyloctyl Salicylate, Microcrystalline Wax, Butyrospermum Parkii (Shea) Butter, Silica.

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)
baby
mineral
SUNSCREEN STICK
UVA/UVB BROAD SPECTRUM SPF 50
50
Water
Resistant
(80 Minutes)
0.5 OZ. (14.2g)
93040707

PDP labelPDP label

Back LabelBack Label

FREE FROM
Oxybenzone
Octinoxate
50
BANANA BOAT(R)
WONT
RUN INTO
EYES
PEDIATRICIAN
TESTED
baby
mineral
SUNSCREEN STICK
UVA/UVB BROAD SPECTRUM SPF 50
No Added
Dyes &
Fragrances
0.5 OZ.
(14.2.g)

Front CardFront Card

Back CardBack Card

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-164-61BANANA BOAT14.2 g in 1 TUBESTICK14.23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-164BANANA BOAT (ZINC OXIDE) STICK [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, 1 package rows20231004_05bbe530-df26-e598-e063-6394a90a0c59.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-16463354-164-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CERESINQ1LS2UJO3AIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ZINC OXIDESOI2LOH54ZACTIB
MICROCRYSTALLINE WAXXOF597Q3KYIACT
MINERAL OILT5L8T28FGPIACT

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 LLC05bbe530-df26-e598-e063-6394a90a0c592023-10-03WarningsExact identifier
ndc (package): 63354-164-61
ndc (product): 63354-164
ndc11 (package): 63354016461
spl id: 06d73d47-c91d-b3a3-e063-6294a90aa135
spl set id: 05bbe530-df26-e598-e063-6394a90a0c59

Reported adverse events (FAERS/openFDA)#

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