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 309 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	f296e5ef-728a-4d57-8d65-7d88b1f90f88	2023-12-31	Warnings	Exact identifier application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Face Lightweight, non-greasy feel 3 essential ceramides niacinamide Mineral	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	bcf5e724-b40a-49dd-8a09-57cefd7f65ad	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Correct Broad Spectrum SPF 70 Daily Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	a7c01228-02db-49a8-bb91-cee13fbd1df1	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	202d8dda-b425-498f-aa82-1470c0cf0c23	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face and Body Cooling Water Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	e72ae48f-e4ec-458b-ae2b-bd6cb98552f9	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Pigmentclar Daily Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	197ea8bf-0d84-42cb-bf29-087ad9587877	2023-12-31	Warnings	Exact identifier application number: M020
CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE	L'Oreal USA Products, Inc.	2138f86b-3937-4c2b-9568-d40a745b637d	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	533e6623-108e-4d05-8527-c5af643f0800	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense 24 Hour Hydrating Moisturizer Broad Spectrum SPF 20 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	2f90f046-080b-4033-97b0-245fcc0f3683	2023-12-31	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	L'Oreal USA Products Inc	27d82e37-67ac-4cd3-83c0-fb8388d3a0dd	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 30 Cooling Water Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	d7bf3928-85b8-4e5f-a04a-d520130a3340	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios AOX Daily Antioxidant Serum Broad Spectrum SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	dc1a1b9f-fcc1-45bc-89e7-169bf240663d	2023-12-31	Warnings	Exact identifier application number: M020
CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	8e94e203-d3cf-45a1-88f9-6999f0aab22b	2023-12-31	Warnings	Exact identifier application number: M020
Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	30cb2f12-1ebe-4850-be16-17748f0ba670	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	74ea4031-bb23-4028-ae32-78213646f66c	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Facial Fuel Daily Energizing Moisture Treatment for Men Broad Spectrum SPF 20 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	dd6134f8-e2e0-49bf-bfec-ab04bfa5678b	2023-12-30	Warnings	Exact identifier application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Oil Free Matte Broad Spectrum 50 Plus Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	3d9ed59f-f280-4cc2-a0f1-4180deb5b792	2023-12-30	Warnings	Exact identifier application number: M020
IT Cosmetics Your Skin But Better CC Plus Nude Glow Color Correcting Medium Coverage Skin Tint Brightening Glow Serum Broad Spectrum SPF 40 Sunscreen All Shades	HOMOSALATE, OCTISALATE AND OCTOCRYLENE	IT COSMETICS, LLC	2bdc6c73-d3e7-4a23-89dd-e4ffe44c034b	2023-12-30	Warnings	Exact identifier application number: M020
Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	02c51b56-e39a-4b3b-88c6-b7dc9c165f7e	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	eb43177e-389d-4572-8521-ee4d0a2dad3a	2023-12-30	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