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 321 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB Cream	ZINC OXIDE	Gin Amber Beauty LLC	32f48fe4-5788-449e-9ed8-9cd8b2ecc1c0	2023-11-14	Warnings	Exact identifier application number: M020
Private Label SPF 50 80 min Water Resistant	HOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREEN	Swiss-American CDMO, LLC	8849fa88-24c8-410d-b16e-60da38288f98	2023-11-14	Warnings	Exact identifier application number: M020
Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50	ZINC OXIDE	Galderma Laboratories, L.P.	0d09b812-b3ca-4214-bed7-7e21ee3288b7	2023-11-14	Warnings	Exact identifier application number: M020
DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15	AVOBENZONE, HOMOSALATE, OCTISALATE	ESTEE LAUDER INC	0a0bfe4a-53b6-5b7c-e063-6394a90a23ec	2023-11-13	Warnings	Exact identifier application number: M020
Bull Frog SPF 50 Mosquito Coast Sunscreen Plus Inspect Repellent	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BULLFROG BRANDS, LLC.	f70b39c6-9f40-f5c1-e053-6394a90a1d43	2023-11-13	Warnings	Exact identifier application number: M020
Bull Frog SPF 50	AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00%	Bullfrog Brands, LLC	c90fc29e-d9fe-a6c9-e053-2995a90a69b3	2023-11-13	Warnings	Exact identifier application number: M020
Tropical Sands, SPF-50 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	493551d0-10a0-3d78-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M020
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	494a7886-d677-1648-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M020
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	ab691543-e37a-487a-912e-56d2e0e4d30a	2023-11-11	Warnings	Exact identifier application number: M020
LBri Pure nNatural Oil Free Moisturizer	OCTINOXATE, AVOBENZONE, OCTISALATE	L'Bri Health & Beauty	47f6ab9e-fa47-496a-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M020
PURE HAVEN BODY SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Pure haven, LLC	6f298fcd-8a97-8f66-e053-2991aa0adb10	2023-11-11	Warnings	Exact identifier application number: M020
Sunstation All-Natural SPF 30 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sunstation USA, LLC	499d366a-a7f1-6070-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier application number: M020
PURE HAVEN Face Sunscreen SPF-30	ZINC OXIDE	Pure Haven, LLC	1fff88a0-4d23-4cd7-872e-1a0b8c680342	2023-11-11	Warnings	Exact identifier application number: M020
Pure Haven Essentials	TITANIUM DIOXIDE, ZINC OXIDE	Pure Haven LLC	4bccc017-266d-11ce-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M020
No BS SPF20 Moisturizer	OCTINOXATE, AVOBENZONE, OCTOCRYLENE	Product Management LLC	690f68fa-d110-4a75-9a14-04aac1be4584	2023-11-11	Warnings	Exact identifier application number: M020
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Kapa'ihi, Inc	66e5eb1b-4ef0-459d-8428-b3e2f221bc85	2023-11-11	Warnings	Exact identifier application number: M020
Sea Star Sparkle SPF-50 PARTY CAKE	OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	MJ Products Association, LLC	8cfaf1b6-0f25-4770-9760-2440b2c153b7	2023-11-11	Warnings	Exact identifier application number: M020
Sea Star Sparkle SPF-50 VERY BERRY	OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	MJ Products Association, LLC	88c403ea-7c78-423e-b05e-1e17c21c5a53	2023-11-11	Warnings	Exact identifier application number: M020
FITGLOW Vita Shield Hyaluronic Primer SPF-30	ZINC OXIDE	FITGLOW BEAUTY LLC	b9ba7783-74ca-4736-8a60-169215859047	2023-11-11	Warnings	Exact identifier application number: M020
BLUE MONARCH Tinted SPF-50 (Rose Gold)	ZINC OXIDE	Blue Monarch, LLC	9ba00a03-1015-4946-8c9b-5ef377a32e4b	2023-11-11	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