TiZO3

Product NDC: 58892-326
Requested package NDC: 58892-326-85
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

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 40 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f45f7953-c103-4900-e053-2a95a90ae399	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c888ce-3a3f-972b-e053-2a95a90a4fe3	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKNI TINT	PML NYC, LLC	f4c44eb6-0a3d-2848-e053-2a95a90a58f3	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c8925c-ac54-43b1-e053-2995a90a916c	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c8b011-5e1d-378c-e053-2a95a90a09cf	2026-04-18	Warnings	Exact identifier application number: M020
EltaMD UV Daily SPF40	ZINC OXIDE AND OCTINOXATE SUNSCREEN	CP Skin Health Group, Inc.	d967b7d0-453a-4420-886a-70ecf46528d2	2026-04-17	Warnings	Exact identifier application number: M020
ELROEL Pang Pang Sun Cushion S7	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	MONOGLOT HOLDINGS Inc.	256bf56f-aefa-47ce-890c-5a3896c11b92	2026-04-17	Warnings	Exact identifier application number: M020
HOLIKA HOLIKA ALOE CICA UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE	Enprani Co., Ltd.	4fa30449-5332-1492-e063-6394a90a585f	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	3a43c7c0-7468-4b7a-95b9-f03e37f1b49b	2026-04-17	Warnings	Exact identifier application number: M020
FORGESKIN	MINERAL TALLOW SUNSCREEN	GUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD	4fa7e67d-cfc5-9f73-e063-6394a90ada50	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	a251eb20-02e6-4b55-b969-c1bef2f9d732	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair Pink	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	6684d69a-89ff-41e8-81f0-3e2367811a18	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	bf24d081-85f7-4a26-9416-ecff1fe59dec	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	4a09a01a-404f-4b67-91e0-666153f550e8	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion N-Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	cf7c4445-0382-47ab-aba9-b40d63e4f1cc	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	80c60ffa-69e0-4b31-bd0d-fc8ff9936ba0	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	0e18d601-700a-4c1c-a434-22582253bd95	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Bronze	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	ddb3aa5e-cd1a-4792-b1b1-3604b368e010	2026-04-17	Warnings	Exact identifier application number: M020
House of Colour Tinted Sunscreen SPF 50	ZINC OXIDE	House of Colour, Inc.	763f5534-cda1-43f2-8a37-1eaa6a43c2e8	2026-04-17	Warnings	Exact identifier application number: M020
Sugargirl SPF 30 Sunscreen Illuminating Stick Sunlight	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	28c9f019-34fe-4568-ba35-38eb3c4cb19e	2026-04-17	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	Sample	Exclude flag	Status
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