BANANA BOAT

Product NDC: 63354-051
11-digit product format: 633540051
Labeler code: 63354
Product ID: 63354-051_5d1652f1-a23b-059c-e053-2991aa0adde5
Type: HUMAN OTC DRUG
Nonproprietary name: TITANIUM DIOXIDE, ZINC OXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: Edgewell Personal Care LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-10-04
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 3 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63354-051		D	Discontinued by firm	2026-10-12
excluded package	package	63354-051	63354-051-11	D	Discontinued by firm	2026-10-12
excluded package	package	63354-051	63354-051-14	D	Discontinued by firm	2026-10-12
excluded package	package	63354-051	63354-051-16	D	Discontinued by firm	2026-10-12
excluded package	package	63354-051	63354-051-17	D	Discontinued by firm	2026-10-12
excluded package	package	63354-051	63354-051-18	D	Discontinued by firm	2026-10-12

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 2 · 90 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63354-051-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63354-051-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63354-051-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63354-051-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63354-051-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63354-051-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63354-051-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63354-051-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63354-051-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63354-051-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63354-051-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63354-051-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63354-051-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63354-051-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63354-051-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63354-051-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63354-051-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63354-051-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63354-051-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63354-051-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63354-051-17	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63354-051-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63354-051-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63354-051-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63354-051-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63354-051-17	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63354-051-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63354-051-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63354-051-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63354-051-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63354-051-17	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63354-051-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63354-051-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63354-051-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63354-051-14	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63354-051-17	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63354-051-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63354-051-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63354-051-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63354-051-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63354-051-17	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63354-051-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63354-051-18	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63354-051-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63354-051-14	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63354-051-17	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63354-051-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63354-051-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63354-051-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63354-051-14	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63354-051-11	2024-01-09	521b8ef2-35f8-43e4-9d7b-67eba99544bf
63354-051-14	2024-01-09	521b8ef2-35f8-43e4-9d7b-67eba99544bf
63354-051-16	2024-01-09	521b8ef2-35f8-43e4-9d7b-67eba99544bf
63354-051-17	2024-01-09	521b8ef2-35f8-43e4-9d7b-67eba99544bf
63354-051-18	2024-01-09	521b8ef2-35f8-43e4-9d7b-67eba99544bf
63354-051-11	2022-01-28	521b8ef2-35f8-43e4-9d7b-67eba99544bf
63354-051-14	2022-01-28	521b8ef2-35f8-43e4-9d7b-67eba99544bf
63354-051-16	2022-01-28	521b8ef2-35f8-43e4-9d7b-67eba99544bf
63354-051-17	2022-01-28	521b8ef2-35f8-43e4-9d7b-67eba99544bf
63354-051-18	2022-01-28	521b8ef2-35f8-43e4-9d7b-67eba99544bf

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)	INACTIVE INGREDIENT	V2W71V8T0X	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
ETHYLHEXYL METHOXYCRYLENE	INACTIVE INGREDIENT	S3KFG6Q5X8	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
ISOHEXADECANE	INACTIVE INGREDIENT	918X1OUF1E	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]	1

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
63354-051-11	63354005111	61 g in 1 TUBE (63354-051-11)	61 g	2012-10-04	0000-00-00	No	No	Current
63354-051-14	63354005114	184 g in 1 TUBE (63354-051-14)	184 g	2012-10-04	0000-00-00	No	No	Current
63354-051-16	63354005116	245 g in 1 TUBE (63354-051-16)	245 g	2012-10-04	0000-00-00	No	No	Current
63354-051-17	63354005117	306 g in 1 TUBE (63354-051-17)	306 g	2012-10-04	0000-00-00	No	No	Current
63354-051-18	63354005118	368 g in 1 TUBE (63354-051-18)	368 g	2012-10-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BANANA BOAT - Edgewell Personal Care LLC	Edgewell Personal Care LLC	2017-11-03	HUMAN OTC DRUG LABEL	2