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 53 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sei Bella Tinted BB Moisturizing Cream	115 N	Melaleuca Inc.	2f132cc0-e8e3-35e3-e063-6394a90a4f3d	2026-03-17	Warnings	Exact identifier application number: M020
Tinted Sunscreen Broad SPF30	TINTED SUNSCREEN BROAD SPF30	DOSCHER FAMILY HEALTH NP P.C.	4d4021ba-4b29-6b81-e063-6294a90a5ea7	2026-03-17	Warnings	Exact identifier application number: M020
SOME BY MI TRUECICA AQUA CALMING SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PERENNEBELL Co., Ltd.	4d42d5aa-d12e-1086-e063-6294a90a12df	2026-03-17	Warnings	Exact identifier application number: M020
GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CLIO COSMETICS Co., Ltd.	bce6008b-3dab-44e4-9a07-d996bf652d07	2026-03-17	Warnings	Exact identifier application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 23	ZINC OXIDE, OCTISALATE, OCTOCRYLENE	PFD Co.,Ltd.	4d206947-1e89-7ef1-e063-6394a90a7d07	2026-03-16	Warnings	Exact identifier application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 25	ZINC OXIDE, OCTISALATE, OCTOCRYLENE	PFD Co.,Ltd.	4d207687-b58f-916d-e063-6394a90a737f	2026-03-16	Warnings	Exact identifier application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 31	ZINC OXIDE, OCTISALATE, OCTOCRYLENE	PFD Co.,Ltd.	4d20a060-fedd-d2f2-e063-6294a90a5cc0	2026-03-16	Warnings	Exact identifier application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 27	ZINC OXIDE, OCTISALATE, OCTOCRYLENE	PFD Co.,Ltd.	4d210edf-0966-87c8-e063-6394a90a30c7	2026-03-16	Warnings	Exact identifier application number: M020
Advanced Formula Lip Balm SPF 25 Blood Orange	AVOBENZONE, OCTINOXATE	Anthony Skin LLC	74853b40-a773-4488-98a9-c8029ad21134	2026-03-16	Warnings	Exact identifier application number: M020
Advanced Formula Lip Balm SPF 25	AVOBENZONE, OCTINOXATE	Anthony Skin LLC	74d7bc30-db15-4cfc-8918-40897d54da70	2026-03-16	Warnings	Exact identifier application number: M020
CVS SPF 70 Sport Face Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS	26e66240-97ae-103d-e063-6394a90a9b5a	2026-03-16	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 45	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Beierdorf Inc	f2a06097-b066-8631-e053-2a95a90a9ffc	2026-03-16	Warnings	Exact identifier application number: M020
Ultra Light Invisible SPF 40 sunscreen	HOMOSALATE 8%, OCTISALATE 5.0%, AVOBENZONE 3.0%, OCTOCRYLENE 4.0%	RK Shea LLC	02d59d96-0edb-472c-b730-148a2eb4fa4a	2026-03-16	Warnings	Exact identifier application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 SOFT SAND	ZINC OXIDE	COSMAX USA	4d31038e-a032-3ce9-e063-6394a90a889d	2026-03-16	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	4ce3d79b-fec5-8501-e063-6294a90a479d	2026-03-15	Warnings	Exact identifier application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	4ce59571-132a-c633-e063-6294a90a8d97	2026-03-15	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	4ce63abb-e716-40de-e063-6394a90a6e76	2026-03-15	Warnings	Exact identifier application number: M020
GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CLIO COSMETICS Co., Ltd.	8d147089-709f-4468-a47d-9251e737c9a4	2026-03-15	Warnings	Exact identifier application number: M020
Cay Skin Isle Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Cay Skin, Inc.	d92a17c4-9827-5fb1-e053-2a95a90a9ca1	2026-03-13	Warnings	Exact identifier application number: M020
DAILY FACE SUNSCREEN Broad Spectrum SPF 30	ZINC OXIDE	Lilyana Naturals LLC	e5f53e2f-6566-4eac-b9b5-7697abaf044b	2026-03-13	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