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: 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: TiZO Ultra Zinc SPF 40 (Tinted)
Listing expiration: 2027-12-31

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 327 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEY	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	867a88df-9a18-447f-8301-2ec91566302e	2023-11-06	Warnings	Exact identifier application number: M020
CALIFORNIA MANGO SPF-30 SUNSCREEN	AVOBENZONE, OCTISALATE, OCTOCRYLENE	CALMANGO, INC	e0de0504-763d-4518-8a9c-67724077701d	2023-11-06	Warnings	Exact identifier application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Men	TITANIUM DIOXIDE, ZINC OXIDE	ACTIVE LIFE INC	bf766aab-a52d-41e8-a06a-f2e536d2219b	2023-11-06	Warnings	Exact identifier application number: M020
PROJECT REEF SPF-50	ZINC OXIDE, TITANIUM DIOXIDE	Project Reef LLC	6bcd470c-6994-4d28-8370-4cc9d68e1e78	2023-11-06	Warnings	Exact identifier application number: M020
BB OSKIN Broad Spectrum SPF-30	TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE	O'Skin Studio NY	d84cca38-b673-484e-aa25-df58d904d4d3	2023-11-06	Warnings	Exact identifier application number: M020
MIAMI MD SUN SHIELD Broad Spectrum SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BRAND BOLT LLC	3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd	2023-11-06	Warnings	Exact identifier application number: M020
JOY SPRING Kids Mineral Sunscreen SPF-30	ZINC OXIDE	JOYSPRING HOLDINGS LLC	76613a3d-f4a8-4961-b36a-d84b4e10dea0	2023-11-06	Warnings	Exact identifier application number: M020
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Aruba Aloe Balm NV	80461b6d-b1b7-4220-894d-8bd425909474	2023-11-06	Warnings	Exact identifier application number: M020
Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick	ZINC OXIDE	Aruba Aloe Balm NV	3201cc8b-5fee-4f3b-a826-e349786d1b32	2023-11-06	Warnings	Exact identifier application number: M020
Broad Spectrum SPF50 Water Resistant (80 minutes) Mineral Sunscreen UVA UVB Protection Stick for Kids	ZINC OXIDE	Aruba Aloe Balm NV	25f060eb-628c-4a11-b1d7-06922ee86b24	2023-11-06	Warnings	Exact identifier application number: M020
SPF30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATE	Zhejiang Ayan Biotech Co., Ltd.	44321dff-1a61-452f-8324-6de2a196db51	2023-11-06	Warnings	Exact identifier application number: M020
SPF30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATE	Zhejiang Ayan Biotech Co., Ltd.	cac6f5e5-91c2-4978-bffd-5ca2a7590637	2023-11-06	Warnings	Exact identifier application number: M020
SPF15 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Zhejiang Ayan Biotech Co.,Ltd.	68035415-47c3-4eed-93f4-bb6b26c9149a	2023-11-06	Warnings	Exact identifier application number: M020
SPF30 Sunscreen and Antibacterial Hand Sanitizer	ALCOHOL, AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Zhejiang Ayan Biotech Co., Ltd.	b5e2458f-8e84-4e57-b6f7-e428a94c97a4	2023-11-06	Warnings	Exact identifier application number: M020
SPF30 Sunscreen and SPF15	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Zhejiang Ayan Biotech Co.,Ltd.	6c40259b-565a-46d0-90d0-ccc186764552	2023-11-06	Warnings	Exact identifier application number: M020
Image Skincare Prevention Plus Daily Ultimate Protection	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREEN	Swiss-American CDMO, LLC	3473f94c-5faf-4415-9605-f58ec93cd268	2023-11-06	Warnings	Exact identifier application number: M020
Image MD Restoring Lip Enhancer SPF15	SUNSCREEN	Swiss-American CDMO, LLC	e296579e-ba30-4a29-afe0-bb51f863369c	2023-11-06	Warnings	Exact identifier application number: M020
Image Prevention Refiner Primer SPF50	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	Swiss-American CDMO, LLC	0e490f11-666c-420c-8c12-b45cd238ce47	2023-11-06	Warnings	Exact identifier application number: M020
Image Prevention Plus Professional Ultimate Protection Moisturizer SPF50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREEN	Swiss-American CDMO, LLC	d807f94a-f933-47d9-938f-b91f663af078	2023-11-06	Warnings	Exact identifier application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 01 Light	TITANIUM DIOXIDE	Farmasi US LLC	97c1da03-b79c-46a3-a9f0-7aeb94ed66da	2023-11-05	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