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 155 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarite Makeup Foundation for a Clearer Appearance SPF 30 170-N	OCTINOXATE, ZINC OXIDE	BEL STAR S A	b56f5883-be57-e0e5-e053-2a95a90adb0c	2025-11-29	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Baby Mineral sunscreen Sprayer SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44a94a24-e292-41e6-e063-6394a90abe47	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral sunscreen Sprayer SPF 50 Tropical coco	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44a98951-6b25-6ee7-e063-6394a90a5433	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral sunscreen Sprayer SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44a9838e-06a6-5a98-e063-6394a90aaba1	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sensitive natural Mineral sunscreen Sprayer SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44a9d7c1-a4cf-d7bb-e063-6394a90a1f47	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sensitive natural Mineral Sunscreen Stick SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	4495a302-51b9-3bf2-e063-6294a90a7e4f	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral sunscreen Sprayer SPF 50 Watermelon and coco	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44aa1349-e3f1-9b80-e063-6294a90a0fbd	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44aaa3c8-ccc4-ae93-e063-6394a90aedc5	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Baby Mineral sunscreen SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44aba591-04da-fe09-e063-6394a90a912a	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44aba6d7-7989-0637-e063-6394a90a6c8f	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Tropical coco	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44abca13-8ba9-8925-e063-6294a90accb5	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sensitive natural baby Mineral sunscreen SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44abdfe1-ea6b-a158-e063-6294a90a3eb8	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Watermelon and coco	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44aca1d5-6e0a-def3-e063-6294a90aca26	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Sun kissed vanilla	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44aca181-2a90-20a6-e063-6394a90aff47	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral sunscreen Sprayer SPF 50 Sun kissed vanilla	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44aa529b-2077-3660-e063-6394a90aa405	2025-11-28	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip Balm SPF 15 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ad65f0-ec1d-1638-e063-6294a90a2244	2025-11-28	Warnings	Exact identifier application number: M020
HOEGOA Hair Scalp Sunscreen Mineral	TITANIUM DIOXIDE	Guangzhou Hoegoa Biotechnology Co., Ltd.	44b37930-b302-338c-e063-6394a90a5f7f	2025-11-28	Warnings	Exact identifier application number: M020
OCEAURA Glitter Sunscreen	TITANIUM DIOXIDE	Guangzhou Oceaura Biotechnology Co., Ltd.	44b47284-57cd-2e61-e063-6394a90a5072	2025-11-28	Warnings	Exact identifier application number: M020
OUHOE Moisturizing And Translucent Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	34e8e4a6-2782-9a3d-e063-6394a90a84c2	2025-11-27	Warnings	Exact identifier application number: M020
OUHOE Protection Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	4272dcef-eda5-1013-e063-6294a90adf38	2025-11-27	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