FDA.reportPublic FDA data

Banana Boat Sunscreen Lip Balm UVA/UVB Broad Spectrum SPF 45

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:10

Label at a glance#

ProductBanana Boat Sunscreen Lip Balm UVA/UVB Broad Spectrum SPF 45
Active ingredientOCTOCRYLENE, HOMOSALATE, AVOBENZONE, OCTISALATE
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 • after eating or drinking • 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 protecti...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

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.

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 • after eating or drinking • 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

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Butyloctyl Salicylate, PEG-8, Oryza Sativa (Rice) Bran Wax, Flavor, Sodium Saccharin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Mineral Oil, Aloe Barbadensis Leaf Extract.

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

MOISTURIZES
FOR 12 HRS
BANANA
BOAT®
45
UVA/UVB
PROTECTION
BROAD SPECTRUM SPF 45
Sunscreen
LIP BALM
Water Resistent (80 minutes)
with ALOE VERA
& VITAMIN E
FREE FROM
Oxybenzone
Octinoxate
NET WT. 0.15 oz. (4.25 g)

Front CardFront Card

Back CardBack Card

63354-971-61 Label63354-971-61 Label

BANANA
BOAT®
Sunscreen
LIP BALM
45
UVA/UVB BROAD SPECTRUM SPF 45
with ALOE VERA & VITAMIN E
Water Resistent (80 minutes)

BANANA
BOAT®
Sunscreen
LIP BALM
45
UVA/UVB BROAD SPECTRUM SPF 45
with ALOE VERA & VITAMIN E
NET WT 0.15 OZ (4.25 g) PEEL HERE

63354-971-61 Peel-Back Label63354-971-61 Peel-Back Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix9302595563354-971-61 Label.jpg, 63354-971-61 Peel-Back Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-971-61Banana Boat Sunscreen Lip Balm UVA/UVB Broad Spectrum SPF 454.25 g in 1 CYLINDERSTICK4.254

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
63354-97163354-971-61

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
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COCONUT OILQ9L0O73W7LIACT
ALOE VERA LEAFZY81Z83H0XIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYL PALMITATE2865993309IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
RICE BRANR60QEP13ICIACT
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
OCTISALATE4X49Y0596WACTIB
PETROLATUM4T6H12BN9UIACT

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 Boat Sunscreen Lip Balm UVA/UVB Broad Spectrum SPF 45AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc794592c-d24e-4530-e053-2995a90a7e4d2025-11-06WarningsExact identifier
ndc (package): 63354-971-61
ndc (product): 63354-971
ndc11 (package): 63354097161
spl id: 42f16fea-5e20-f8e5-e063-6394a90aef0a
spl set id: c794592c-d24e-4530-e053-2995a90a7e4d

Reported adverse events (FAERS/openFDA)#

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