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 38 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN	ZINC OXIDE	Zouck LLC	507560fe-c7ad-329a-e063-6394a90a039a	2026-04-27	Warnings	Exact identifier application number: M020
SoloVegan	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	YES SALES INC.	435748e6-c39a-efee-e063-6294a90ad0e5	2026-04-27	Warnings	Exact identifier application number: M020
SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN	ZINC OXIDE	Zouck LLC	50764f40-7881-81a3-e063-6294a90ad1cf	2026-04-27	Warnings	Exact identifier application number: M020
Obagi Skintrinsiq Antioxidant Protocol	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Obagi Cosmeceuticals LLC	495bc176-b292-448f-a5a6-00de2e475e54	2026-04-27	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f45bd7bd-a802-33e4-e053-2a95a90a61a7	2026-04-23	Warnings	Exact identifier application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER	TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER	PML NYC, LLC	1c2e9b0d-ba0e-1767-e063-6394a90a756c	2026-04-23	Warnings	Exact identifier application number: M020
Skincare LdeL Retinol Day Broad Spectrum SPF 20	AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATE	Beauty Solutions, Ltd.	76e2ed34-c643-402b-9c9d-04eac789d3c2	2026-04-22	Warnings	Exact identifier application number: M020
Johnsons Baby Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	4fe04c4b-2751-0561-e063-6394a90af768	2026-04-22	Warnings	Exact identifier application number: M020
Johnsons Baby Mineral Sunscreen Stick SPF 50	ZINC OXIDE	Kenvue Brands LLC	4fe1d3c6-7748-d966-e063-6394a90a97ff	2026-04-22	Warnings	Exact identifier application number: M020
OVERLAPS ECTOIN MOIST SUN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Overlaps Corp.	4c3ed60b-e515-8ff0-e063-6294a90a86df	2026-04-22	Warnings	Exact identifier application number: M020
Lazy Face SPF 30 Facescreen	TITANIUM DIOXIDE, ZINC OXIDE	Sunny Day Creations	500ee303-7302-68d5-e063-6394a90ac6d4	2026-04-22	Warnings	Exact identifier application number: M020
Lazy Face SPF 30 Facestick	ZINC OXIDE	Sunny Day Creations	50101b55-793e-dbe4-e063-6394a90a6199	2026-04-22	Warnings	Exact identifier application number: M020
Broad Spectrum Sunscreen SPF 30	OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%	S&C Hampton Sun LLC	e6103de6-1d80-46fd-b9d4-893f60941def	2026-04-22	Warnings	Exact identifier application number: M020
PhotoAge Guard	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	MACROMOTION, INC.	50164bd8-469d-9ec1-e063-6294a90a543d	2026-04-22	Warnings	Exact identifier application number: M020
THANK YOU FARMER Sun Project Silky Calming Sun Stick	AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE	THANK YOU FARMER CO., LTD	49947114-5137-dc45-e063-6394a90ad9d0	2026-04-22	Warnings	Exact identifier application number: M020
Sky and Sol Intense Healing Lip Jelly	NON-NANO ZINC OXIDE	Delta Ecommerce LLC	2ddaa215-7433-c8fa-e063-6394a90a4316	2026-04-22	Warnings	Exact identifier application number: M020
Broad Spectrum SPF45	ZINC OXIDE, OCTINOXATE	Drmtlgy, LLC	0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8	2026-04-21	Warnings	Exact identifier application number: M020
BLDG Active Skin Repair Face and Body Performance Sunscreen	ZINC OXIDE	Innovacyn, Inc.	70cb98cf-739b-4d46-b45a-535ff0a4531c	2026-04-21	Warnings	Exact identifier application number: M020
Freaks of Nature Mineral Sunscreen	ZINC OXIDE MINERAL SUNSCREEN	Empack Spraytech Inc.	4ffdb1c6-b2c6-628f-e063-6394a90a2769	2026-04-21	Warnings	Exact identifier application number: M020
THANK YOU FARMER Sun Project Water Sun Cream	AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE	THANK YOU FARMER CO., LTD	5004126b-0a9c-21fb-e063-6294a90a5237	2026-04-21	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