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 60 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perfect Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SKIN PERFECT MEDICAL	4b93538a-3b3e-90f7-e063-6294a90ab898	2026-02-24	Warnings	Exact identifier application number: M020
ANTI-AGING TINTED SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	LASER GIRL SKINCARE, LLC	4b93cd22-1289-29bc-e063-6294a90ab781	2026-02-24	Warnings	Exact identifier application number: M020
ANTI-AGING TINTED SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	LASER GIRL SKINCARE, LLC	4b943d72-dcde-e2e4-e063-6294a90ab7c4	2026-02-24	Warnings	Exact identifier application number: M020
ANTI-AGING NON-TINTED SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	LASER GIRL SKINCARE, LLC	4b946c39-718b-d70e-e063-6394a90a0db8	2026-02-24	Warnings	Exact identifier application number: M020
Reunited Lipgloss SPF 30 - BTCH IS BACK	HOMOSALATE, OCTOCRYLENE, OCTISALATE	Princeville Productions, LLC, DBA Reunited Beauty	4b961531-fbca-d1cf-e063-6294a90ab9a1	2026-02-24	Warnings	Exact identifier application number: M020
sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer, Inc.	8f5e634c-765b-4ffe-bb12-753d64c90cf9	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	e97bf30a-1465-4912-bd55-1e7dd993132b	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	67efcd94-00af-477b-bd14-d1c7b95d305a	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	3f3d2e1e-1e95-4719-8ca9-83b6b804ab9f	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Sheer Touch Sunscreen Mist SPF 100	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	f642788c-3643-459a-b736-0c06d0cd32a9	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	95ba2b33-f593-4e95-bd6e-5910d6aa5158	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	3b85004a-8832-4eac-bd70-1e607ae7af4b	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	7f0fc23b-2d70-4426-9d64-a6d2b643309f	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	0ae9edd8-bf76-4bb2-ab78-c43c017ba4a5	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Avbenzone, Homosalate, Octisalate	AVBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	f8960995-66b6-4197-8976-b318fe01488f	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Broad Spectrum Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	c76f5639-bd0f-4987-8c70-224ee33bbbad	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	8795b9a7-1938-4dd9-92ad-3c044feae1da	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Meijer, Inc.	3f8bad95-8071-47b1-88a7-3a3f09f097b5	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M020
UV RESTORE FACE SERUM SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	BETTER INNOVATION LTD	4b9a881a-835b-ef0c-e063-6394a90a94af	2026-02-24	Warnings	Exact identifier application number: M020
MISTINE UV DEFENSE FACE MOISTURIZER SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BETTER INVENTION LTD	4b9a9303-662f-9614-e063-6294a90a6b51	2026-02-24	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