TiZO3

Product NDC: 58892-326
11-digit product format: 588920326
Labeler code: 58892
Product ID: 58892-326_468d6476-127b-e9f0-e063-6294a90a3df9
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Fallien Cosmeceuticals Ltd.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-05-10
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 85.4; 40.7 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58892-326		I	Inactivated by FDA	2026-10-23
excluded product	product	58892-326		I	Inactivated by FDA	2026-10-23
excluded package	package	58892-326	58892-326-20	I	Inactivated by FDA	2026-10-23
excluded package	package	58892-326	58892-326-50	I	Inactivated by FDA	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 · 52 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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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 product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58892-326-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58892-326-20	`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 product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58892-326-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58892-326-20	`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 product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58892-326-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58892-326-20	`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 product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58892-326-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`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	58892-326-20	`110d247fa046…`	`a55b01930146…`

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: TiZO3
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	85.4 mg/mL
ZINC OXIDE	40.7 mg/mL

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
468d6476-127a-e9f0-e063-6294a90a3df9	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58892-326-50	2024-10-02	C162847	48780-1	1030e365-68ea-111a-e063-dadaa90a10e2	DRUG FACTS
58892-326-50	2024-01-30	C162847	48780-1	1030e365-68ea-111a-e063-dadaa90a10e2	DRUG FACTS
58892-326-20	2019-11-27	C162847	48780-1	9855d018-e65d-cd31-e053-dbdaa90ab51a	a5d22c0f-c55b-4344-ba7f-1b40d3b7c5a3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58892-326-50	TiZO3	44.4 mL in 1 TUBE	CREAM	44.4	4
58892-326-50	TiZO3	1 in 1 CARTON	CREAM	1	4
58892-326-20	Solar Protection Formula TiZO3 Sunscreen	44.4 mL in 1 TUBE	CREAM	44.4	2
58892-326-20	Solar Protection Formula TiZO3 Sunscreen	1 in 1 CARTON	CREAM	1	2
58892-326-05	TiZO3	5 mL in 1 TUBE	CREAM	5	1
58892-326-85	TiZO3	85 mL in 1 BOTTLE, PUMP	CREAM	85	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-326	TIZO3 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	4	Current NDC, Legacy NDC, 2 package rows	20241004_2e53defe-98a3-4689-8763-35d76b5701c3.zip
58892-326	SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2	Current NDC, Legacy NDC, 2 package rows	20121208_a5d22c0f-c55b-4344-ba7f-1b40d3b7c5a3.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 186 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS SPF 60 Face Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS	26d1b568-ad9c-80d7-e063-6394a90a2cbf	2025-09-21	Warnings	Exact identifier application number: M020
Radiant Shield Tinted Mineral Sunscreen SPF 40	ZINC OXIDE	CosMedical Technologies, LLC	f229b928-49fd-4e02-99c1-b2cd9166894f	2025-09-19	Warnings	Exact identifier application number: M020
EquateDaytimeFaceLotion	EQUATE DAYTIME FACE LOTION WITH SUNSCREEN, SPF 30, 3 OZ	Walmart Inc.	2efc7087-f4ad-2f2e-e063-6394a90a1302	2025-09-18	Warnings	Exact identifier application number: M020
ERBORIAN CC RED CORRECT	ERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM	Kolmask Co., Ld.	09ca2d4b-e0c2-9961-e063-6394a90aa82e	2025-09-18		Exact identifier application number: M020
ELROEL Pang Pang Sun Cushion Plus	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	MONOGLOT HOLDINGS Inc.	5ffaad65-f0b2-416a-b0a3-b92e880641e4	2025-09-18	Warnings	Exact identifier application number: M020
e.l.f. Camo CC Cream SPF 30 Fair 125 C	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	e.l.f. Cosmetics, Inc.	407f9c0d-31c6-f5bb-e063-6394a90a4db4	2025-09-18	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	1630feee-7e0d-c6f4-e063-6294a90a7b1c	2025-09-17	Warnings	Exact identifier application number: M020
Guise Tinted Drops	ZINC OXIDE	Donis Men LLC	3f039049-5004-2888-e063-6294a90a5150	2025-09-17	Warnings	Exact identifier application number: M020
ONE SIZE ON TIL DAWN	ONE SIZE ON TIL DAWN	Pogi Beauty LLC	3f05d90b-9274-4d21-e063-6294a90a8485	2025-09-17	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint DP3	ZINC OXIDE	PUR Minerals	3f073413-b314-e5da-e063-6394a90a9ab4	2025-09-17	Warnings	Exact identifier application number: M020
e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 W	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	e.l.f. Cosmetics, Inc.	3fa7ef54-2c4d-9883-e063-6294a90a8d88	2025-09-17	Warnings	Exact identifier application number: M020
CVS SPF 50 Face Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CVS	26a69a47-947a-a478-e063-6394a90aa468	2025-09-16	Warnings	Exact identifier application number: M020
SkinSuit TM 3 in 1 Moisturizer SPF 50	ZINC OXIDE	Skin Authority LLC	5eb27be9-9e80-4f4a-b193-b918d831555d	2025-09-15	Warnings	Exact identifier application number: M020
Sun and Honey Tallow Sunscreen SPF 30	ZINC OXIDE	Amara Ventures	3eda8a70-7c9e-e920-e063-6394a90a85a2	2025-09-15	Warnings	Exact identifier application number: M020
Klein Tools Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	KLEIN TOOLS, INC.	3edcc26a-d960-3fa8-e063-6394a90ab703	2025-09-15	Warnings	Exact identifier application number: M020
Klein Tools Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	KLEIN TOOLS, INC.	3ede5e54-4c9f-02f7-e063-6294a90a9df6	2025-09-15	Warnings	Exact identifier application number: M020
I.C. Industrial Sunscreen	ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE	R & R Lotion, Inc	b89d687a-7b36-4643-9817-765d4710ca60	2025-09-15	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	97795f0e-d867-4e17-b7c9-ede08e7df70c	2025-09-12	Warnings	Exact identifier application number: M020
Oh My Bod Light Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	3e9db4f5-d9d9-ddf3-e063-6394a90a99fc	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	2d05659c-57d2-4faf-ab67-1b8d68945aed	2025-09-12	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
58892-326-05	58892032605	5 mL in 1 TUBE (58892-326-05)	5 ml	2015-05-10		No	No	Current
58892-326-20	58892032620	44.4 mL in 1 TUBE	44.4 ml					Historical
58892-326-50	58892032650	1 TUBE in 1 CARTON (58892-326-50) > 44.4 mL in 1 TUBE	1 tube	2015-03-25	0000-00-00	No	No	Current
58892-326-85	58892032685	85 mL in 1 BOTTLE, PUMP (58892-326-85)	85 ml	2007-05-21		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TiZO3 - Fallien Cosmeceuticals, LTD \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	Fallien Cosmeceuticals, LTD \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	2026-04-02	HUMAN OTC DRUG LABEL	1
TiZO3	Fallien Cosmeceuticals Ltd. \| Custom Analytics LLC \| Fragrance Manufacturing Inc.	2025-12-22	HUMAN OTC DRUG LABEL	1
DRUG FACTS	Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2024-10-01	HUMAN OTC DRUG LABEL	4
Titanium Dioxide, Zinc Oxide - Fallien Cosmeceuticals, LTD. \| Custom Analytics LLC \| Process Technologies & Packaging	Fallien Cosmeceuticals, LTD. \| Custom Analytics LLC \| Process Technologies & Packaging	2012-12-07	HUMAN OTC DRUG LABEL	2