TiZO Ultra Zinc SPF 40 (Tinted)

Product NDC: 58892-319
11-digit product format: 588920319
Labeler code: 58892
Product ID: 58892-319_25a288aa-1828-492a-e063-6294a90ae5c3
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Fallien Cosmeceuticals, LTD
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-01-15
Substance: ZINC OXIDE
Active strength: 200 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: TiZO Ultra Zinc SPF 40 (Tinted)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
36efd48b-910e-4b61-9519-a6d5c7e9a7c3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58892-319-01	TiZO Ultra Zinc SPF 40 (Tinted)	100 g in 1 TUBE	CREAM	100	4
58892-319-01	TiZO Ultra Zinc SPF 40 (Tinted)	1 in 1 CARTON	CREAM	1	4
58892-319-05	TiZO Ultra Zinc SPF 40 (Tinted)	5 g in 1 TUBE	CREAM	5	1
58892-319-15	TiZO Ultra Zinc SPF 40 (Tinted)	1.5 g in 1 PACKET	CREAM	1.5	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-319	TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	4	Current NDC, Legacy NDC, 2 package rows	20241031_36efd48b-910e-4b61-9519-a6d5c7e9a7c3.zip
58892-319	TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]	1	Current NDC, Legacy NDC, 1 package rows	20250212_2d3faa43-0d78-58de-e063-6294a90a0b17.zip
58892-319	TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	1	Current NDC, Legacy NDC, 1 package rows	20250212_2d0856cf-d3da-5a77-e063-6294a90ad5b4.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 224 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	2d2c58e2-0d15-4383-adae-12fc17b8ea50	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	1907126c-fd95-86e8-e063-6394a90a23ca	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus	ZINC OXIDE	Kenvue Brands LLC	4504a10d-6130-4ec5-823a-ab970709e6d7	2025-03-20	Warnings	Exact identifier application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Eai-jr 286, Inc	30caf1dd-142d-85d3-e063-6394a90a0c88	2025-03-20	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Cranberry Tangerine	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	f39606be-19c8-58d1-e053-2a95a90a908f	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	aa937596-2378-469f-a0e1-9700044e83b3	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Way to Glow Kit	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	f6f6e219-4ef6-be3b-e053-6294a90a660d	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	e8d19915-8996-42df-a47b-2ce00d2bbe68	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42	ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	21bde283-a554-45c8-8733-2a8adeff41b1	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE	SHISEIDO AMERICAS CORPORATION	7a98171f-bf21-40d4-bc78-883aa0b0c438	2025-03-20	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	5e2d7c94-d70a-47e4-9a4b-5953fe38ede2	2025-03-19	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	50206f9e-2dd5-494f-9eed-f7d7ea6efda9	2025-03-18	Warnings	Exact identifier application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40	ZINC OXIDE	The Creme Shop	30a4280b-4a9f-4c18-e063-6394a90a85e6	2025-03-18	Warnings	Exact identifier application number: M020
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45	ZINC OXIDE	Eai-jr 286, Inc	30a5ec14-63d7-e678-e063-6294a90abb57	2025-03-18	Warnings	Exact identifier application number: M020
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Extra Shade, LLC	d197dfe3-c754-4a3d-9edd-335f3fce105c	2025-03-18	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	c88e44da-0b0e-4744-8b4b-4d9d418f29d7	2025-03-18	Warnings	Exact identifier application number: M020
MDP UV BIO SUNSCREEN	ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	SKINIDEA CO., LTD	3087771e-2ab8-2198-e063-6294a90a37d4	2025-03-17	Warnings	Exact identifier application number: M020
belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H CO., LTD.	2b38da59-b83e-4285-e063-6294a90ac6a7	2025-03-17	Warnings	Exact identifier application number: M020
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	263ef8e8-e0c4-42e6-bb26-7581a437b35a	2025-03-14	Warnings	Exact identifier application number: M020
Impact Melanoma SPF 30	ZINC OXIDE	RENU LABORATORIES, LLC	f953302e-f712-129a-e053-6294a90ab9a8	2025-03-13	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58892-319-01	58892031901	1 TUBE in 1 CARTON (58892-319-01) / 100 g in 1 TUBE	1 tube	2022-03-15	0000-00-00	No	No	Current
58892-319-05	58892031905	5 g in 1 TUBE (58892-319-05)	5 g	2022-03-15		Yes	No	Current
58892-319-15	58892031915	1.5 g in 1 PACKET (58892-319-15)	1.5 g	2022-03-15		Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zinc Oxide - Fallien Cosmeceuticals, LTD. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	Fallien Cosmeceuticals, LTD. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	2025-02-03	HUMAN OTC DRUG LABEL	1
Zinc Oxide - Fallien Cosmeceuticals, LTD \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	Fallien Cosmeceuticals, LTD \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	2025-01-31	HUMAN OTC DRUG LABEL	1
Zinc Oxide - Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2024-10-29	HUMAN OTC DRUG LABEL	4