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 325 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spit and Polish Mineral Lip Balm Broad Spectrum Lip Protectant SPF 30	ZINC OXIDE	Naturally Uncommon, LLC	af882b7e-c64f-0de6-e053-2995a90a7ca0	2023-11-09	Warnings	Exact identifier application number: M020
EltaMD UV AOX Mist	ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	1062efb1-a638-4323-88f8-f2f98a5b996e	2023-11-09	Warnings	Exact identifier application number: M020
EltaMD UV Active	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc.	2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd2	2023-11-09	Warnings	Exact identifier application number: M020
Physical Sunscreen SPF50 80 min WR 159-100	TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN	Swiss-American CDMO, LLC	0cca7b65-e24a-429c-b157-5f4e343424ab	2023-11-09	Warnings	Exact identifier application number: M020
Private Label Sunscreen SPF35 40min WR RE126-202	HOMOSALATE, ZINC OXIDE SUNSCREEN	Swiss-American CDMO, LLC	254fa69f-2413-47e8-bc9b-5b7b0b59a5c8	2023-11-09	Warnings	Exact identifier application number: M020
PLANTSCRIPTION SPF 25 POWER ANTI-AGING oil FREE BROAD SPECTRUM	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	91c14980-ba63-4705-a465-581fe11d0a98	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a20dc51a-1f6c-4a6d-97f6-2f048e0689a0	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a6c8b20f-6377-443b-a89b-8b5d40c65ad8	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	b6591b2e-9e55-4f25-958c-f36f1ef85749	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	6e2ae7cb-c390-4996-95e8-ae8fadefa8bd	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a143c8cb-185c-4fd8-a901-3c0d9ffb8290	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	3d6e438d-9ea4-4253-9153-748d3c974265	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	173aeaab-a286-48ed-9033-10b13f547bbd	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	d877575a-25f3-49bd-b403-ecf6a1eb483a	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	24e1e576-9edd-45aa-a883-2a2d18a1cb5e	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 6N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a8fffe38-5f90-4078-b553-30036659a2ee	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	bfa2b2be-958c-439f-b363-2623df2b8501	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	15f73322-0b27-4412-b368-84bc768f55e8	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	51392fe6-fbbb-4ea9-a7aa-98e1711eaa5d	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	b70b8ffc-091a-4969-86a7-6c3e1b9b9d74	2023-11-08	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