Banana Boat

Product NDC: 63354-078
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63354-078		D	Discontinued by firm	2026-10-05
excluded package	package	63354-078	63354-078-34	D	Discontinued by firm	2026-10-05
excluded package	package	63354-078	63354-078-35	D	Discontinued by firm	2026-10-05
excluded package	package	63354-078	63354-078-36	D	Discontinued by firm	2026-10-05
excluded package	package	63354-078	63354-078-37	D	Discontinued by firm	2026-10-05
excluded package	package	63354-078	63354-078-38	D	Discontinued by firm	2026-10-05
excluded package	package	63354-078	63354-078-39	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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 NDC	Product	Description	Form	Quantity	SPL version
63354-078-34	Banana Boat	170 g in 1 CAN	SPRAY	170	9
63354-078-35	Banana Boat	212 g in 1 CAN	SPRAY	212	9
63354-078-36	Banana Boat	227 g in 1 CAN	SPRAY	227	9
63354-078-37	Banana Boat	269 g in 1 CAN	SPRAY	269	9
63354-078-38	Banana Boat	340 g in 1 CAN	SPRAY	340	9
63354-078-39	Banana Boat	452 g in 1 CAN	SPRAY	452	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63354-078	BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS, LLC]	8	Legacy NDC, 6 package rows	20241127_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Banana Boat	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands, LLC	767a1504-1e02-1e06-e053-2a91aa0aa4b6	2025-11-06	Warnings	Exact identifier ndc (product): 63354-078

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63354-078-34	63354007834	170 g in 1 CAN (63354-078-34)	170 g	2018-10-15	0000-00-00	No	No	Current
63354-078-35	63354007835	212 g in 1 CAN (63354-078-35)	212 g	2018-10-31	0000-00-00	No	No	Current
63354-078-36	63354007836	227 g in 1 CAN (63354-078-36)	227 g	2018-10-15	0000-00-00	No	No	Current
63354-078-37	63354007837	269 g in 1 CAN (63354-078-37)	269 g	2018-10-15	0000-00-00	No	No	Current
63354-078-38	63354007838	340 g in 1 CAN (63354-078-38)	340 g	2018-10-15	0000-00-00	No	No	Current
63354-078-39	63354007839	452 g in 1 CAN (63354-078-39)	452 g	2018-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Banana Boat - Edgewell Personal Care Brands, LLC	Edgewell Personal Care Brands, LLC	2025-11-06	HUMAN OTC DRUG LABEL	9