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 338 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Strawberry Limoncello SPF 15 Broad Spectrum Lip Balm	STRAWBERRY LIMONCELLO SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	c222bd6e-59b0-394a-e053-2995a90ae429	2023-10-18	Warnings	Exact identifier application number: M020
Raspberry Lime Margarita SPF 15 Broad Spectrum Lip Balm	RASPBERRY LIME MARGARITA SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	c2150247-ff7d-9863-e053-2995a90a3f01	2023-10-18	Warnings	Exact identifier application number: M020
Key Lime Pie Shake SPF 15 Broad Spectrum Lip Balm	KEY LIME PIE SHAKE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	c214e5c2-53ea-31bd-e053-2995a90a886a	2023-10-18	Warnings	Exact identifier application number: M020
Summer Sangria SPF 15 Broad Spectrum Lip Balm	SUMMER SANGRIA SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	c222cc2d-232c-0f3d-e053-2995a90af79b	2023-10-18	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Mineral Sun Stick	BROAD SPECTRUM SPF 30 MINERAL SUN STICK	Raining Rose	c2261a55-12e4-9a75-e053-2a95a90a8211	2023-10-18	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Sunscreen	BROAD SPECTRUM SPF 30 SUNSCREEN	Raining Rose	c238ce45-91d9-e9fa-e053-2a95a90a7d65	2023-10-18	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Sunscreen	BROAD SPECTRUM SPF 30 SUNSCREEN	Raining Rose	c23d49bd-8447-4920-e053-2a95a90a0a06	2023-10-18	Warnings	Exact identifier application number: M020
Tropical Mint Broad Spectrum SPF 15 Lip Moisturizer	TROPICAL MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZER	Raining Rose, Inc	aef6b419-efac-4e37-e053-2995a90a0d2f	2023-10-18	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Cherry Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN CHERRY LIP BALM	Raining Rose	efbd2179-5f6d-a8c6-e053-2a95a90a17e7	2023-10-18	Warnings	Exact identifier application number: M020
Vanilla Mint Broad Spectrum SPF 15 Lip Moisturizer	VANILLA MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZER	Raining Rose, Inc	af10a007-6597-2231-e053-2995a90a8717	2023-10-18	Warnings	Exact identifier application number: M020
Mint Broad Spectrum SPF 15 Lip Moisturizer	MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZER	Raining Rose, Inc	af471721-54e4-0738-e053-2a95a90a7e12	2023-10-18	Warnings	Exact identifier application number: M020
Spearmint SPF 15 Broad Spectrum Lip Balm	SPEARMINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a9029e6d-7443-efe2-e053-2995a90a8125	2023-10-18	Warnings	Exact identifier application number: M020
Watermelon Twist SPF 15 Broad Spectrum Lip Balm	WATERMELON TWIST SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a903a7cc-0de5-5adc-e053-2a95a90aa961	2023-10-18	Warnings	Exact identifier application number: M020
Vanilla Mint SPF 15 Broad Spectrum Lip Balm	VANILLA MINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a9031b15-d2b0-d248-e053-2a95a90a65ff	2023-10-18	Warnings	Exact identifier application number: M020
Cherry SPF 15 Broad Spectrum Lip Balm	CHERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a75a7326-aaa4-767b-e053-2995a90adf16	2023-10-18	Warnings	Exact identifier application number: M020
Wildberry SPF 15 Broad Spectrum Lip Balm	WILDBERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a903c855-867b-4f14-e053-2a95a90a5333	2023-10-18	Warnings	Exact identifier application number: M020
Tropical SPF 15 Broad Spectrum Lip Balm	TROPICAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a903202b-1dc6-85ad-e053-2995a90a4ab8	2023-10-18	Warnings	Exact identifier application number: M020
Pomegranate SPF 15 Broad Spectrum Lip Balm	POMEGRANATE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a901e45d-2ea6-bae8-e053-2a95a90afc98	2023-10-18	Warnings	Exact identifier application number: M020
Vanilla SPF 15 Broad Spectrum Lip Balm	VANILLA SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a903a7cc-0dd5-5adc-e053-2a95a90aa961	2023-10-18	Warnings	Exact identifier application number: M020
Raspberry SPF 15 Broad Spectrum Lip Balm	RASPBERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a902917c-b8fb-b2d0-e053-2995a90a42db	2023-10-18	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