FDA.reportPublic FDA data

Banana Boat

Manufacturer
Edgewell Personal Care Brands, LLC | Playtex Manufacturing Inc
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:29:07

Label at a glance#

ProductBanana Boat
Active ingredientTITANIUM DIOXIDE, ZINC 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

• Shake well • 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 includ...

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 • 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. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Shake well • 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

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

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®
baby
mineral
100% MINERAL BASED SUNSCREEN LOTION
UVA/UVB BROAD SPECTRUM SPF 50+
50+
PEDIATRICIAN TESTED
tear free
NO OXYBENZONE & PARABENS
Water Resistant
(80 Minutes)
6 FL. OZ. (177 mL)

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
63354-922-24Banana Boat177 g in 1 TUBELOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-922BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS, LLC]5Legacy NDC, 1 package rows20241025_617bf6e8-2457-3fd7-e053-2991aa0aedda.zip

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
63354-92263354-922-24

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

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
252aceff-1e0f-3b1c-e063-6394a90a3db0617bf6e8-2457-3fd7-e053-2991aa0aedda2024-10-23WarningsExact identifier
spl id: 252aceff-1e0f-3b1c-e063-6394a90a3db0
spl set id: 617bf6e8-2457-3fd7-e053-2991aa0aedda

Reported adverse events (FAERS/openFDA)#

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