UV Defense Fluid

Product NDC: 65903-171
11-digit product format: 659030171
Labeler code: 65903
Product ID: 65903-171_8b291140-d4a3-4952-a404-1c0b008e3b2b
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: H2O Plus
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-04-01
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 11 g/100mL; g/100mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65903-171		I	Inactivated by FDA		2026-10-16
excluded package	package	65903-171	65903-171-01	I	Inactivated by FDA		2026-10-16

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 · 44 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	65903-171-01	`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	65903-171-01	`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	65903-171-01	`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	65903-171-01	`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	65903-171-01	`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	65903-171-01	`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	65903-171-01	`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	65903-171-01	`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	65903-171-01	`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	65903-171-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65903-171-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65903-171-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65903-171-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65903-171-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65903-171-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65903-171-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65903-171-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65903-171-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65903-171-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65903-171-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65903-171-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65903-171-01	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65903-171-01	2019-11-27	C162847	48780-1	9855e2a2-48ae-60a7-e053-dbdaa90a05bd	UV Defense Fluid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65903-171-01	UV Defense Fluid	30 mL in 1 BOTTLE, WITH APPLICATOR	CREAM	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
.Alpha.-Hexylcinnamaldehyde	INACTIVE INGREDIENT	7X6O37OK2I	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Alkyl (C12-15) Benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Benzyl Benzoate	INACTIVE INGREDIENT	N863NB338G	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Calcium Carbonate	INACTIVE INGREDIENT	H0G9379FGK	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Caprylyl Glycol	INACTIVE INGREDIENT	00YIU5438U	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Dimethicone/Vinyl Dimethicone Crosspolymer (Hard Particle)	INACTIVE INGREDIENT	H895X08VNQ	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Dipropylene Glycol	INACTIVE INGREDIENT	E107L85C40	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Ferulic Acid	INACTIVE INGREDIENT	AVM951ZWST	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Glycyrrhizinate Dipotassium	INACTIVE INGREDIENT	CA2Y0FE3FX	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Green Tea Leaf	INACTIVE INGREDIENT	W2ZU1RY8B0	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Hyaluronate Sodium	INACTIVE INGREDIENT	YSE9PPT4TH	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Isodecyl Isononanoate	INACTIVE INGREDIENT	4X46Q4U00Z	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone	INACTIVE INGREDIENT	25G622K2RA	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Limonene, (-)-	INACTIVE INGREDIENT	47MAJ1Y2NE	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Linalool, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
PEG/PPG-18/18 Dimethicone	INACTIVE INGREDIENT	9H0AO7T794	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Phyllanthus Emblica Fruit	INACTIVE INGREDIENT	YLX4CW2576	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Potassium Sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Rosemary	INACTIVE INGREDIENT	IJ67X351P9	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Tetrahydrodiferuloylmethane	INACTIVE INGREDIENT	00U0645U03	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Tocopherol	INACTIVE INGREDIENT	R0ZB2556P8	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Undaria Pinnatifida	INACTIVE INGREDIENT	ICV1OK7M1S	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65903-171	UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]	1	Legacy NDC, 1 package rows	20140415_7062d96c-3b39-4d21-a2ae-7a8d9df3c96a.zip

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	Status
65903-171-01	65903017101	30 mL in 1 BOTTLE, WITH APPLICATOR	30 ml	Historical