FDA.reportPublic FDA data

Banana Boat

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2024-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:22:17

Label at a glance#

ProductBanana Boat
Active ingredientHOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENE
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

Avobenzone 2.7%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 5.0%

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. 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

Water, Glycerin, Silica, Dimethicone, Isohexadecane, Phenoxyethanol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Sodium Polyacrylate, Chlorphenesin, Disodium EDTA, Glyceryl Stearate, PEG-100 Stearate, Ceramide NP, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANANA BOAT
SPORT
face
SUNSCREEN LOTION
UVA/UVB BROAD SPECTRUM SPF 50
50
INSTANTLY
RUBS IN CLEAR
Won't Clog Pores
Sweat | Water Resistant (80 Minutes)
3 FL. OZ. (89 mL)

PDPPDP

Back LabelBack Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-773-12Banana Boat89 g in 1 BOTTLELOTION891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-773BANANA BOAT (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]1Current NDC, 1 package rows20241001_1d4cab02-8897-6449-e063-6294a90ad72e.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-77363354-773-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-100 STEARATEYD01N1999RIACT
ALOE VERA LEAFZY81Z83H0XIACT
HOMOSALATEV06SV4M95SACTIB
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
ISOHEXADECANE918X1OUF1EIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CERAMIDE NP4370DF050BIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHLORPHENESINI670DAL4SZIACT
OCTOCRYLENE5A68WGF6WMACTIB

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 BoatAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC1d4cab02-8897-6449-e063-6294a90ad72e2024-07-15WarningsExact identifier
ndc (package): 63354-773-12
ndc (product): 63354-773
ndc11 (package): 63354077312
spl id: 1d4cab02-8898-6449-e063-6294a90ad72e
spl set id: 1d4cab02-8897-6449-e063-6294a90ad72e

Reported adverse events (FAERS/openFDA)#

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