Banana Boat

Product NDC: 63354-755
11-digit product format: 633540755
Labeler code: 63354
Product ID: 63354-755_2529b8fc-9cc0-acfb-e063-6394a90a5f16
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Edgewell Personal Care Brands, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-01-02
Marketing end: 2026-12-01
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 4.5; 6.5 g/100g; g/100g
NDC exclude flag: No
Current FDA listing: Yes

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63354-755	63354-755-21	D	Discontinued by firm		2026-10-23

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 · 10 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Banana Boat

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	4.5 g/100g
ZINC OXIDE	6.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
441a46f0-ecda-4448-e054-00144ff88e88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63354-755-21	Banana Boat	29 g in 1 TUBE	LOTION	29	9
63354-755-27	Banana Boat	270 g in 1 TUBE	LOTION	270	9
63354-755-54	Banana Boat	177 g in 1 BOTTLE	LOTION	177	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63354-755	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS, LLC]	9	Current NDC, Legacy NDC, 3 package rows	20241025_441a46f0-ecda-4448-e054-00144ff88e88.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 96 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coppertone Tanning Sunscreen SPF 15	AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	cc5dafd4-dfd4-d310-e053-2995a90a82a8	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone EveryTone Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	04c58384-fd82-f6d0-e063-6294a90a3ff1	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdort Inc	cc46b3a3-48f5-4593-e053-2995a90a8782	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sport SPF 60 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	23fb7304-789d-1f94-e063-6394a90a7e62	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	cbf9a785-f218-76fb-e053-2995a90a8e03	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Glow Hydragel Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	b60c2a38-ef92-0dff-e053-2995a90a47c4	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 30	(TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	0a5a5370-ec6f-42a7-e063-6394a90ac37c	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d53e1253-f6a4-4f3d-e053-2a95a90a79ed	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Face SPF 60 Plus Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	04b36eb1-bffc-c31e-e063-6294a90a8eb3	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	d47460a1-4768-ee44-e053-2a95a90adecf	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sunscreen SPF 50	ZINC OXIDE 20%	Beiersdorf Inc	d46359e7-b585-c43a-e053-2995a90a0863	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d473e7ed-4a9f-76fe-e053-2995a90ab37d	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Every Tone Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	f3e3f4c6-2cb9-7b17-e053-2a95a90a3854	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Every Tone Age Defense Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	23f88c88-b68e-4706-e063-6294a90afb38	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8%	Beiersdorf Inc	d473113d-2fc3-6b1c-e053-2a95a90a88ed	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%	Beiersdorf Inc	d89df7a5-7741-3e1d-e053-2995a90ae275	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	d475e14f-dab1-dec5-e053-2995a90aef73	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	d4757d99-bac6-48fb-e053-2a95a90ab1bf	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	24d3fbbc-0bce-b47a-e063-6394a90a9afa	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella CC Brightening Creme Light	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	6894b9d9-a5b5-4c98-e053-2991aa0a9ca2	2025-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63354-755-01	63354075501	11 g in 1 PACKET (63354-755-01)	11 g	2017-01-02	0000-00-00	No	No	Current
63354-755-21	63354075521	29 g in 1 TUBE (63354-755-21)	29 g	2017-01-02	0000-00-00	No	No	Current
63354-755-27	63354075527	270 g in 1 TUBE (63354-755-27)	270 g	2017-01-02	2026-12-01	No	No	Current
63354-755-54	63354075554	177 g in 1 BOTTLE (63354-755-54)	177 g	2017-01-02	2026-12-01	No	No	Current
63354-755-56	63354075556	221 g in 1 BOTTLE (63354-755-56)	221 g	2017-01-02	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	2024-10-23	HUMAN OTC DRUG LABEL	9