FDA.reportPublic FDA data

Banana Boat

Product NDC
63354-078
Requested package NDC
63354-078-36
11-digit product format
633540078
Labeler code
63354
Product ID
63354-078_edfe9dee-0b4d-3cf6-e053-2995a90a0f65
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands, LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-10-15
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63354-07863354-078-36DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-078-34Banana Boat170 g in 1 CANSPRAY1709
63354-078-35Banana Boat212 g in 1 CANSPRAY2129
63354-078-36Banana Boat227 g in 1 CANSPRAY2279
63354-078-37Banana Boat269 g in 1 CANSPRAY2699
63354-078-38Banana Boat340 g in 1 CANSPRAY3409
63354-078-39Banana Boat452 g in 1 CANSPRAY4529

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-078BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS, LLC]8Legacy NDC, 6 package rows20241127_767a1504-1e02-1e06-e053-2a91aa0aa4b6.zip

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, LLC767a1504-1e02-1e06-e053-2a91aa0aa4b62025-11-06WarningsExact identifier
ndc (package): 63354-078-36
ndc (product): 63354-078
ndc11 (package): 63354007836

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-078-3663354007836227 g in 1 CAN (63354-078-36) 227 g2018-10-150000-00-00NoNoCurrent