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 194 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CoTZ Kids	ZINC OXIDE	Fallien Cosmeceuticals, LTD.	3ca914e2-cd53-42bf-e063-6294a90a7082	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	Sun Bum, LLC	3b1a0596-b852-16be-e063-6394a90a3498	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZ	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3b29dbfc-0b92-eb0f-e063-6294a90a16e1	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 30 Mineral Sunscreen 32 OZ	ZINC OXIDE	Sun Bum, LLC	3b2cb7cf-7e2c-0fd2-e063-6294a90a3b17	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Sunscreen Oil 50 5 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b2b4ba0-3f89-0a04-e063-6294a90ac1c0	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Signature Sunscreen Premium Zinc Lip Balm Broad Spectrum SPF 30	ZINC OXIDE	Sun Bum, LLC	3ca9e9d3-1c73-7bd6-e063-6394a90ad204	2025-08-18	Warnings	Exact identifier application number: M020
Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous Sunscreen	ZINC OXIDE	GNL BRANDS INTERNATIONAL, LLC	3caaea85-0dfe-6f69-e063-6294a90a7d4a	2025-08-18	Warnings	Exact identifier application number: M020
PLAY Lip Shield SPF 30 - Mint	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop LLC	3cab1a7d-6226-9eba-e063-6294a90a8c4d	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Broad Spectrum SPF 30 5 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3cad0757-3155-c716-e063-6294a90ad7a9	2025-08-18	Warnings	Exact identifier application number: M020
Cica Redness Solution Sunscreen	ZINC OXIDE	Meebak Beauty, Inc	15eea1eb-9468-4611-915d-e43112c4a4f5	2025-08-18	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE/OCTOCRYLENE	Edgewell Personal Care Brands LLC	3c936ed0-ab7a-ccec-e063-6294a90afd93	2025-08-17	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE OCTOCRYLENE OXYBENZONE	Edgewell Personal Care Brands LLC	0f772b91-e67b-46cf-e054-00144ff8d46c	2025-08-17	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, OCTOCRYLENE, OXYBENZONE	EdgewellPersonal Care Brands LLC	353353b9-54f8-4300-9632-7615de394076	2025-08-17	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	0c6aeadb-f61d-29e3-e063-6294a90a7473	2025-08-17	Warnings	Exact identifier application number: M020
MOISTURE SURGE SPF	AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE	CLINIQUE LABORATORIES LLC	ec921e21-db68-db77-e053-2a95a90a5781	2025-08-15	Warnings	Exact identifier application number: M020
Olay Invisible Sunscreen Facial Primer plus Sunscreen Broad Spectrum SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	3c69f096-1575-309b-e063-6394a90a7229	2025-08-15	Warnings	Exact identifier application number: M020
MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOR	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	ea4d564f-ac64-abac-e053-2a95a90a8abb	2025-08-15	Warnings	Exact identifier application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Sunset Cove Carded	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3ac67c26-d56e-32a9-e063-6294a90a1048	2025-08-15	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Sun Bum, LLC	3aa13423-045a-7227-e063-6294a90ae49b	2025-08-15	Warnings	Exact identifier application number: M020
Sun Bum Daily Sunscreen Mist Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a796a0b-8021-9a9f-e063-6294a90a6eb2	2025-08-15	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