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 57 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENE	Old East Main Co.	db876d34-1af9-4e0a-9e9a-32a8b00e9405	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE	Old East Main Co.	2ea288fe-815d-4568-9592-55ea428448fa	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	cea1c223-c9d4-42ac-8c5b-c0ca647d57a1	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Old East Main Co.	00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	8f4a6a31-2fae-42fe-924f-10237c59e791	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ef48288b-533f-4924-ba12-fc8cb83643d4	2026-03-02	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	e6976bf4-ad77-4953-858f-4a0ec7f4300c	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	b3d2da09-d9c9-4c27-82fe-a434ece2f099	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ba9331ef-3744-4072-80a2-af95c6f7ee05	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	1a53d8d5-e650-4825-8a3b-7cf42c36e3e5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	086dfda5-9fe7-46b4-9964-4977b86cfdd5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ce9a2139-c5c2-43e2-bd51-1f14ace594d9	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Bask SPF 40 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Surfside Skincare, Inc. dba Bask Suncare	49a30877-e39f-46a3-e063-6394a90a8dd2	2026-03-02	Warnings	Exact identifier application number: M020
Sunscreen SPF30	AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%	Worthy Promotional Products	f6014a97-12d3-4f42-86de-866a206c6c06	2026-03-02	Warnings	Exact identifier application number: M020
2000DL-CL30V	SPF30 BS VANILLA	Epic Laboratories, LLC	02488aad-28be-4ffb-e063-6294a90ad01e	2026-03-02	Warnings	Exact identifier application number: M020
2000DL-CL30T	SPF30 BS TROPICAL	Epic Laboratories, LLC	0286f94e-a2e8-b529-e063-6294a90ac08d	2026-03-02	Warnings	Exact identifier application number: M020
2000DL-CL30V	SPF30 BS ORIGINAL	Epic Laboratories, LLC	1872eefd-d702-ac9f-e063-6294a90a24ef	2026-03-02	Warnings	Exact identifier application number: M020
JAYSUING White Birch Moisturizing Sunscreen Cream	TITANIUM DIOXIDE	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	4c174691-cc32-b2e4-e063-6294a90a0f73	2026-03-02	Warnings	Exact identifier application number: M020
Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And Primer	ZINC OXIDE	Kypris Beauty LLC	a5d5f7bd-d7bf-4a5c-8530-b9d5d74754c3	2026-02-27	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