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 259 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zoey naturals Broad Spectrum SPF 50 Fragrance Free Sunscreen	ZINC OXIDE	Absolutely Natural	6e05e060-a531-4c4a-b273-889407ec5704	2024-12-11	Warnings	Exact identifier application number: M020
Peptide Lip Shine SPF30 Sunscreen	ZINC OXIDE	Colorescience, Inc.	98cdf19d-8b8a-4051-88bb-79160b2af39e	2024-12-11	Warnings	Exact identifier application number: M020
Zoey naturals Broad Spectrum SPF 50Plus Fragrance Free Sunscreen	ZINC OXIDE	Absolutely Natural	082983a4-7b98-489d-8ac2-a185923b86ba	2024-12-11	Warnings	Exact identifier application number: M020
Absolutely Natural Broad Spectrum SPF 50 Sunscreen	ZINC OXIDE	Absolutely Natural	89657538-904d-4908-ba7b-6f84706a8001	2024-12-11	Warnings	Exact identifier application number: M020
SISLEYA Global Anti-Age Hand care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE	C.F.E.B. Sisley	cddf11b1-a89b-4b54-b228-55ba8147f022	2024-12-10	Warnings	Exact identifier application number: M020
SUNLEYA Age minimizing sun care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	C.F.E.B. Sisley	67498d45-0871-4806-8854-81d3e50c4b90	2024-12-10	Warnings	Exact identifier application number: M020
SUPER CREME SOLAIRE CORPS Body sun care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	C.F.E.B. Sisley	1c774aa7-8963-4221-b4b0-b894bd1b941f	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen Cream SPF 30 4-Deep Amber	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	5599922a-b020-477c-a44c-1db42ec5756a	2024-12-10	Warnings	Exact identifier application number: M020
SUNLEYA Age minimizing sun care SPF 50 plus	AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE	C.F.E.B. Sisley	7c9fadaf-b961-4df0-89ae-87141b50b2c1	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen SPF 30 1-Natural	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	b3d53a10-2647-492a-a05f-b97c3f716aa8	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen SPF 30 2-Golden	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	389cbce6-552c-4633-babd-7b672632f0b9	2024-12-10	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	28f08236-1f01-d759-e063-6294a90adcfa	2024-12-10	Warnings	Exact identifier application number: M020
Blistex Five Star Lip Protection Broad Spectrum	HOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONE	Blistex Inc.	47b57317-7df5-442e-a3a4-1d44fe278ac6	2024-12-10	Warnings	Exact identifier application number: M020
AHAVA Brightening Broad Spectrum SPF 20	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	724bbb91-e273-4926-9ad6-a1657ffe4cd8	2024-12-10	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d83c576-5dfb-583a-e063-6294a90a2a28	2024-12-09	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d833e3b-5330-3c5b-e063-6394a90a2ed2	2024-12-09	Warnings	Exact identifier application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d9533ba-5606-4116-e063-6294a90ad3b1	2024-12-09	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d82121d-1dc2-cd99-e063-6394a90aa766	2024-12-09	Warnings	Exact identifier application number: M020
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	310e66a2-8714-4016-87f4-81c1fef19ec9	2024-12-09	Warnings	Exact identifier application number: M020
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	b6b8733d-6431-4ed2-9350-c63bb901c804	2024-12-09	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