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 328 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr. C. Tuna Resurface Essential Day Cream	HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE	Farmasi US LLC	b92ff1e9-9dc4-46cb-a99d-98ff15bffc79	2023-11-05	Warnings	Exact identifier application number: M020
Dr C Tuna Sun protector lip balm SPF 15	HOMOSALATE, OCTINOXATE	Farmasi US LLC	ddcd82b5-9ad2-2340-e053-2a95a90a4fc0	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to Tan	TITANIUM DIOXIDE	Farmasi US LLC	deee5784-c68b-4cd7-acbf-f64391a01bfc	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to Medium	TITANIUM DIOXIDE	Farmasi US LLC	cef1a926-b7d4-47d6-957d-e3092e60970c	2023-11-05	Warnings	Exact identifier application number: M020
Dr. C. Tuna Lumi Radiance Brightening Cream	OCTOCRYLENE, OCTINOXATE, AVOBENZONE	Farmasi US LLC	b55790f7-20f2-404e-9a0e-5e76c383bf75	2023-11-05	Warnings	Exact identifier application number: M020
Dr. C. Tuna Lumi Radiance Brightening Cream 22 SPF	OCTOCRYLENE, OCTINOXATE, AVOBENZONE	Farmasi US LLC	de493e30-d10e-9def-e053-2995a90ae49a	2023-11-05	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sun Face and Body SPF 50	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE	Farmasi US LLC	141f9d22-deb7-4b6b-97b5-ee21898b96f7	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 06 Deep	TITANIUM DIOXIDE	Farmasi US LLC	2f13a160-740f-4b09-8858-e438a9ba303e	2023-11-05	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sun Bronzing Oil SPF 6	OCTINOXATE	Farmasi US LLC	91b428cc-1c80-4d56-8450-790c66de4133	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 05 Tan	TITANIUM DIOXIDE	Farmasi US LLC	3f494921-844e-4010-ab0c-144c8dce8aca	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi CC Color Control Cream SPF 25	TITANIUM DIOXIDE	Farmasi US LLC	f4fcfc78-9591-4a20-b9fb-88e1dc9b221d	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi CC Color Control Cream SPF 25- 02 Light to Medium	TITANIUM DIOXIDE	Farmasi US LLC	0d913242-2e57-4ba7-a718-154af68480b2	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 03 Medium	TITANIUM DIOXIDE	Farmasi US LLC	6ef986df-4044-4c32-8b64-f8110c9c9543	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi CC Color Control Cream SPF 25- 04 Medium to Tan	TITANIUM DIOXIDE	Farmasi US LLC	de24317f-2cf0-4125-bb17-c3d6b3c22e00	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi CC Color Control Cream SPF 25- 05 Tan	TITANIUM DIOXIDE	Farmasi US LLC	22842793-ae1f-4b71-8db9-34c06dc37daa	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi CC Color Control Cream SPF 25- 03 Medium	TITANIUM DIOXIDE	Farmasi US LLC	9f203e7f-3bba-4f36-a35a-6d9466e39082	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi CC Color Control Cream SPF 25- 06 Deep	TITANIUM DIOXIDE	Farmasi US LLC	c28afa3b-9a8d-4e19-bc6b-39cc8428c9f9	2023-11-05	Warnings	Exact identifier application number: M020
DR. C Tuna Sunscreen 30 SPF Broad Spectrum Face and body	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE	TAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	a71ee8e0-2d27-7ae6-e053-2a95a90aecd4	2023-11-05	Warnings	Exact identifier application number: M020
PHARMACA Natural Mineral Sunscreen SPF-50	TITANIUM DIOXIDE, ZINC OXIDE	Pharmaca Integrative Pharmacy, Inc.	51e6cd7a-5c9a-4666-9021-ade42eb064cd	2023-11-05	Warnings	Exact identifier application number: M020
Dr.C.Tuna Sun Face Cream SPF50	AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE	Tan Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret Anonim Sirketi	f668c078-61e6-2c81-e053-2a95a90a3100	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