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		2026-10-21

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 173 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e l f Camo Semi Matte CC SPF 30 Rich 660 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	853100ea-a9dc-43eb-9715-125b543d2be0	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 400 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	e4f2b579-4886-4e20-a527-c033e9d60bf5	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 460 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	49255019-fa24-4667-b527-ef7189a51f12	2025-10-31	Warnings	Exact identifier application number: M020
SEKKISEI HERBAL UV DEFENSE gel	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	KOS America, Inc.	cb0faa3a-68f8-49c5-8c28-3338b1b27cd8	2025-10-31	Warnings	Exact identifier application number: M020
Perricone MD Hypoallergenic Clean Correction Ultra-Lightweight Calming SPF 35 Veil	ZINC OXIDE	THG Beauty USA LLC	2c749a52-adaa-2609-e063-6294a90a8fc2	2025-10-30	Warnings	Exact identifier application number: M020
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	4260e410-d2d5-71b4-e063-6294a90a05b8	2025-10-30	Warnings	Exact identifier application number: M020
Clove Hill Tinted Mineral Sunscreen SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	eb2ff5a7-384f-4379-b149-47c1c8c2291d	2025-10-30	Warnings	Exact identifier application number: M020
Tinted Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	a37db64d-8b79-40f4-843f-f38949c5b9d2	2025-10-30	Warnings	Exact identifier application number: M020
WEIGHTLESS PROTECTION SPF 30	OCTINOXATE, ZINC OXIDE, OCTISALATE	Botanical Science Technologies	de9a97b8-6633-4d71-e053-2995a90a5e8f	2025-10-30	Warnings	Exact identifier application number: M020
Avinichi Noni Sol Shield Cream SPF 30	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	9e534e32-efea-4dcf-adc1-18de3847ac04	2025-10-30	Warnings	Exact identifier application number: M020
MOOYAM Dark Skin Sunscreen	SUNSCREEN	Guangdong Bisutang Biotechnology Co., LTD	4246e9f1-1c51-d888-e063-6394a90abda0	2025-10-29	Warnings	Exact identifier application number: M020
Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	THG Beauty USA LLC	1cd10158-c346-60c9-e063-6294a90a54bd	2025-10-29	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free Face SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	0fb5a140-838d-3226-e063-6294a90a8860	2025-10-29	Warnings	Exact identifier application number: M020
non-tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	311b270f-b9e2-2374-e063-6294a90af581	2025-10-29	Warnings	Exact identifier application number: M020
Hello Bello Kids Mineral Sunscreen	ZINC OXIDE TITANIUM OXIDE	Hello Bello	3e7a3e8e-eacf-0a30-e063-6294a90ab7ec	2025-10-29	Warnings	Exact identifier application number: M020
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25	TITANIUM DIOXIDE	THG Beauty USA LLC	23f4cf41-0eed-2df3-e063-6294a90ad402	2025-10-28	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	0fb58346-a638-3091-e063-6394a90ad754	2025-10-28	Warnings	Exact identifier application number: M020
TIBENA EVERYTHING MULTI CUSHION SPF50	HOMOSALATE, TITANIUM DIOXIDE	KONAD CO LTD	421eda8f-62b2-30fb-e063-6394a90a4947	2025-10-27	Warnings	Exact identifier application number: M020
Bondi Sands Broad Spectrum SPF 60 Sunny Drops Face Serum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	289efa6d-427b-8be6-e063-6394a90adae3	2025-10-27	Warnings	Exact identifier application number: M020
goPure Sunscreen	ZINC OXIDE	Natural Lifestyle Brands, LLC dba GoPure beauty	a74ec20b-8436-4030-820c-01fd88134f40	2025-10-27	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