TiZO2

Product NDC: 58892-336
11-digit product format: 588920336
Labeler code: 58892
Product ID: 58892-336_509cad98-0322-2a0a-e063-6294a90a6ea9
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: 2015-04-27
Substance: ZINC OXIDE; TITANIUM DIOXIDE
Active strength: 40.7; 85.4 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58892-336	58892-336-45	D	Discontinued by firm		2026-11-13

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 · 50 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58892-336-45	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58892-336-45	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58892-336-45	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58892-336-45	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58892-336-45	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58892-336-45	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58892-336-45	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58892-336-45	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58892-336-45	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58892-336-45	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58892-336-45	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58892-336-50	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58892-336-45	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58892-336-50	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58892-336-45	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58892-336-50	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58892-336-45	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58892-336-50	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58892-336-45	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58892-336-45	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58892-336-45	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58892-336-45	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58892-336-45	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58892-336-45	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58892-336-45	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	58892-336-45	I	Inactivated by FDA	`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: TiZO2
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
15FIX9V2JP	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
509cad98-0321-2a0a-e063-6294a90a6ea9	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
58892-336-45	2025-07-28	9855d018-e8c4-cd31-e053-dbdaa90ab51a	30468afc-9616-4765-b046-12e97a0a7827
58892-336-50	2024-10-02	1030e365-59ef-111a-e063-dadaa90a10e2	DRUG FACTS
58892-336-50	2024-01-30	1030e365-59ef-111a-e063-dadaa90a10e2	DRUG FACTS
58892-336-45	2019-11-27	9855d018-e8c4-cd31-e053-dbdaa90ab51a	30468afc-9616-4765-b046-12e97a0a7827

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58892-336-50	TiZO2	50 mL in 1 TUBE	CREAM	50	4
58892-336-50	TiZO2	1 in 1 CARTON	CREAM	1	4
58892-336-45	TiZO2	44.4 mL in 1 TUBE	CREAM	44.4	3
58892-336-45	TiZO2	1 in 1 CARTON	CREAM	1	3
58892-336-05	TiZO2	5 mL in 1 TUBE	CREAM	5	1
58892-336-15	TiZO2	1.5 mL in 1 PACKET	CREAM	1.5	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA 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
58892-336	TIZO2 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	4	Current NDC, Legacy NDC, 2 package rows	20241004_43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a.zip
58892-336	SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	2	Current NDC, Legacy NDC, 2 package rows	20121208_30468afc-9616-4765-b046-12e97a0a7827.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 275 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Health Sport SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	f799bad7-b3df-f9a5-e053-6294a90ab104	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health SPF 30 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	f41e145c-896e-2782-e053-2995a90a5f81	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health AM Moisturizing Facial Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	CVS PHARMACY	f9c89108-1568-ee3e-e053-6294a90ac756	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health 50 Clear Zinc Broad Spectrum SPF 50 Sunscreen	OCTOCRYLENE, ZINC OXIDE	CVS PHARMACY	fa19e9d3-6ab8-cbd6-e053-6294a90aae9b	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health Sport 30 Clear	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	CVS PHARMACY	fbe6ae15-28ef-2acf-e053-6394a90a8d42	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health 45 Ultra Sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	fc4addf0-9a6e-292f-e053-6294a90ab9c0	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health Sport 70	AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	fc4a79ce-208e-2aed-e053-6394a90a06bb	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health Sport 70 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	CVS PHARMACY	fc4bbb80-c3f6-c4f7-e053-6394a90a4cae	2024-10-17	Warnings	Exact identifier application number: M020
SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	DEMOULAS SUPER MARKETS, INC	ee782436-9eff-49e4-8edc-fd9783454c07	2024-10-17	Warnings	Exact identifier application number: M020
GLOW RECIPE WATERMELON GLOW DEW BALM SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE	Aramara Beauty LLC dba Glow Recipe	0c437f88-c731-5834-e063-6394a90a3299	2024-10-17	Warnings	Exact identifier application number: M020
SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	DEMOULAS SUPER MARKETS, INC	5ce3e436-37d1-4918-bb14-0be33b0bc86a	2024-10-17	Warnings	Exact identifier application number: M020
MARKET BASKET KIDS SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	DEMOULAS SUPER MARKETS, INC.	a6a381da-6e34-bffe-e053-2a95a90a46f2	2024-10-17	Warnings	Exact identifier application number: M020
Market Basket Continuous Sunscreen SPF 50	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	DEMOULAS SUPER MARKETS, INC.	f4238107-c76c-266a-e053-2a95a90a8978	2024-10-17	Warnings	Exact identifier application number: M020
Market Basket Continuous Sunscreen General Protection SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	DEMOULAS SUPER MARKETS, INC.	e7182d07-a006-db4b-e053-2995a90aa9e1	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	e467df80-9007-46c9-e053-2a95a90a1bef	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT KIDS SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	e467c306-a2ed-4976-e053-2995a90a56ed	2024-10-17	Warnings	Exact identifier application number: M020
Exchange Select Sport Sunscreen Continuous SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	Army & Air Force Exchange Service	e716ba8c-0148-07f2-e053-2a95a90a53df	2024-10-17	Warnings	Exact identifier application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Army & Air Force Exchange Service	f55828b4-f2a4-13ec-e053-2995a90a0f84	2024-10-17	Warnings	Exact identifier application number: M020
SPF50 Plus Mineral Sunscreen	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	08e8bc10-85d8-4215-8351-7ec12029416c	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	9ac92c96-5bcf-421d-9cd0-73ddfa10195c	2024-10-17	Warnings	Exact identifier application number: M020

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58892-336-05	58892033605	5 mL in 1 TUBE (58892-336-05)	5 ml	2015-04-27		No	No	Current
58892-336-15	58892033615	1.5 mL in 1 PACKET (58892-336-15)	1.5 ml	2015-04-27		No	No	Current
58892-336-45	58892033645	44.4 mL in 1 TUBE	44.4 ml					Historical
58892-336-50	58892033650	1 TUBE in 1 CARTON (58892-336-50) / 50 mL in 1 TUBE	1 tube	2015-04-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TiZO2 - Fallien Cosmeceuticals Ltd. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	Fallien Cosmeceuticals Ltd. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	2026-04-29	HUMAN OTC DRUG LABEL	1
TiZO2 - Fallien Cosmeceuticals Ltd. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	Fallien Cosmeceuticals Ltd. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	2026-04-29	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
TiZO2 - Fallien Cosmeceuticals, LTD. \| Custom Analytics LLC \| Process Technologies & Packaging	Fallien Cosmeceuticals, LTD. \| Custom Analytics LLC \| Process Technologies & Packaging	2010-12-20	HUMAN OTC DRUG LABEL	3