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 16 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair Light	ZINC OXIDE	REJUVA MINERALS INC	2abccc86-01d4-e45c-e063-6294a90a7f8b	2026-07-02	Warnings	Exact identifier application number: M020
OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige	TITANIUM DIOXIDE	LG H&H Co., Ltd.	d307471c-6cc6-ce48-e053-2995a90a3e02	2026-07-02	Warnings	Exact identifier application number: M020
Sunscreen SPF 50	AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%	Worthy Promotional Products	f5e2a412-e891-411d-85da-89f38cd61a9b	2026-07-02	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Bronze Kiss	AVOBENZONE,HOMOSALATE,OCTISALATE	Bath & Body Works, Inc.	5606c57b-7fdb-4317-e063-6294a90a996c	2026-07-02	Warnings	Exact identifier application number: M020
Evereden Kids Mineral Sunscreen SPF 30	ZINC OXIDE	Eden Brands Inc	bba219a4-de83-76fd-e053-2995a90a2d69	2026-07-01	Warnings	Exact identifier application number: M020
Kids Mineral Face Cream SPF20	ZINC OXIDE	Eden Brands Inc	fbfccb0c-e459-3282-e053-6394a90ad95d	2026-07-01	Warnings	Exact identifier application number: M020
Evereden Fluid Silk Mineral Sunscreen PRO SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Eden Brands Inc.	2cb7773f-9a05-ad02-e063-6294a90af024	2026-07-01	Warnings	Exact identifier application number: M020
Zinc Oxide 20%	SUNSCREEN SPF 50	The Beach Rooster	c2e57236-f184-4fa8-8fd5-c44cbf230058	2026-07-01	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ISNTREE Inc.	557477a2-def8-740b-e063-6294a90ad287	2026-06-30	Warnings	Exact identifier application number: M020
HealthyDerm tallow mineral sunscreen SPF50	ZINC OXIDE 25%	VIRENTIA LLC	557b0b1f-8cd9-735a-e063-6294a90ad60e	2026-06-30	Warnings	Exact identifier application number: M020
OHUI Ultimate Cover CC Cushion Compact 01 Light Beige	TITANIUM DIOXIDE	LG H&H Co., Ltd.	d2f9c54b-ac4e-5141-e053-2a95a90aa2b8	2026-06-30	Warnings	Exact identifier application number: M020
Christian Dior Invisible UV Stick Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Parfums Christian Dior	8e3840b2-b404-474f-aff7-dec3a64a70a4	2026-06-29	Warnings	Exact identifier application number: M020
TOCOBO Blur Finish Sun Cushion Cotton Blue	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	PICTON Co., Ltd.	4d6ddee3-9a76-6c9c-e063-6394a90a1529	2026-06-29	Warnings	Exact identifier application number: M020
Sun Bum Coconut Lip 30 Sunscreen Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	20d942fa-93de-45a8-e063-6294a90a2b49	2026-06-29	Warnings	Exact identifier application number: M020
AVON ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	ZINC OXIDE	THE AVON COMPANY	54f7c1d1-acdb-fd25-e063-6294a90a8173	2026-06-29	Warnings	Exact identifier application number: M020
Earth Baby Broad Spectrum SPF 30	SUNSCREEN	Earth Baby, Inc.	42556876-74ea-38e6-e054-00144ff8d46c	2026-06-28	Warnings	Exact identifier application number: M020
TOCOBO Cotton Airy Sun Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	55364026-c55a-b370-e063-6294a90ae0d1	2026-06-27	Warnings	Exact identifier application number: M020
Sun Does Matter Daily Face Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	Sundoesmatter Company Inc.	553687d8-d4e1-8361-e063-6294a90a24fe	2026-06-27	Warnings	Exact identifier application number: M020
ORLASKIN HYDRATING SUNSCREEN SPF 50	OCTOCRYLENE ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE AVOBENZONE	Guangzhou Yapheon Health Industry Co., Ltd.	552b4c87-4621-d5a7-e063-6294a90a042e	2026-06-26	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Waikiki Beach Coconut	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	1c30de8a-4d29-bbac-e063-6294a90a84d9	2026-06-26	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