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 286 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bright as Day Mineral SPF50	ZINC OXIDE	Koco Life LLC	1c245a53-4098-62e6-e063-6294a90abf12	2024-09-23	Warnings	Exact identifier application number: M020
Pure Protect Mineral Sunscreen Stick SPF50	ZINC OXIDE	Koco Life LLC	22cd5999-9b9a-91a3-e063-6394a90a0da5	2024-09-23	Warnings	Exact identifier application number: M020
ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen	ZINC OXIDE	Absolutely Natural	eb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea	2024-09-23	Warnings	Exact identifier application number: M020
SUNSCREEN 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	229dabbc-9043-3c9d-e063-6394a90a5692	2024-09-21	Warnings	Exact identifier application number: M020
GLC OG Natural Tinted SPF 30 Sunscreen	ZINC OXIDE	GUD LIFE CO. LLC	25e1e8ec-e19d-45f7-b339-5d12c2b511d6	2024-09-18	Warnings	Exact identifier application number: M020
Target Up and Up Sunscreen SPF 30 SPORT Broad Spectrum	AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE	TARGET CORPORATION	bad7d56e-662e-0776-e053-2a95a90a0af0	2024-09-18	Warnings	Exact identifier application number: M020
Target Up and Up Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	b82b6d0d-616d-f041-e053-2995a90ae6a3	2024-09-18	Warnings	Exact identifier application number: M020
COOLA Dew Good Illuminating Body Melt SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA LLC	43d293f6-e13c-4ee9-89df-2a3ef0034e31	2024-09-16	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO non-tinted replenishing daily protection	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	2203ea22-d12a-99fe-e063-6394a90aca9f	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Tinted	ZINC OXIDE	Allure Labs	22042031-ac8e-1ab2-e063-6394a90a6ed4	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Tinted	ZINC OXIDE	ONESKIN INC.	2204e776-b1a1-be15-e063-6294a90af5de	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Untinted	ZINC OXIDE	Allure Labs	2205345b-5e92-37eb-e063-6294a90a6b6c	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Untinted	ZINC OXIDE	ONESKIN INC.	2205ec0e-ac3f-299f-e063-6294a90a2174	2024-09-13	Warnings	Exact identifier application number: M020
H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUS	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f4130277-ea9b-6b25-e053-2a95a90a59be	2024-09-13	Warnings	Exact identifier application number: M020
HEB SPF 50 Tattoo Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6df491d-1fa9-a4c8-e053-6394a90a3866	2024-09-13	Warnings	Exact identifier application number: M020
YOUR Day Cream Sunscreen Broad Spectrum SPF 30	OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE	Skin Ai, LLC	21cbd5ac-5307-939b-e063-6294a90ac791	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu SPF 17	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Bentley Laboratories LLC	0fd51f8d-ee67-48fd-ab98-1fedb0339462	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu Collagen SPF 15	AVOBENZONE, OCTINOXATE, OXYBENZONE	Bentley Laboratories LLC	0246b11b-f1ba-4f47-91ab-52a6554b9467	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu The Moisture Magnet SPF 15	AVOBENZONE, OCTINOXATE, OXYBENZONE	Bentley Laboratories LLC	f6d653f5-52a0-42ad-8308-b8d6f57050cc	2024-09-10	Warnings	Exact identifier application number: M020
MARIO BADESCU SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Bentley Laboratories LLC	fe485d4c-0ded-4061-ac34-77b72d535090	2024-09-10	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