Home NDC 58892-319 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 299 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MELAN SPF-30 Antioxidant Body Mist Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MELAN INC. 66b7c899-46fd-41a6-9a96-ebbf2b68ea25 2024-05-02 Warnings Exact identifier application number: M020 No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30 AVOBENZONE,OCTISALATE, OCTOCRYLENE. BCM Ltd 4ce3fe14-e33d-cbf6-e063-6294a90a42fe 2024-04-30 Warnings Exact identifier application number: M020 bareMinerals BAREPRO 24HR Wear Skin-Perfecting Matte Liquid Foundation Fair 10 Neutral ZINC OXIDE Orveon Global US LLC 1740393b-f8a3-475b-e063-6394a90a6fa8 2024-04-29 Warnings Exact identifier application number: M020 SUMMER GELEE SPF-30 HOMOSALATE, OCTISALATE, OCTOCRYLENE SUMMER GELEE LLC bc85db65-2acc-4b39-9189-f8916c487b61 2024-04-27 Warnings Exact identifier application number: M020 SUMMER GELEE SPF-4 HOMOSALATE, OCTISALATE SUMMER GELEE LLC c9ec81ad-0478-4026-bc6c-5582eb012b8d 2024-04-27 Warnings Exact identifier application number: M020 Natural Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sarati International, Inc. 16ef922d-78d1-1e70-e063-6394a90a3bbf 2024-04-25 Warnings Exact identifier application number: M020 PRISMA PROTECT SPF30 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE Dermalogica, LLC. e0e6d779-c491-43ed-acc9-274d1b60c1ff 2024-04-25 Warnings Exact identifier application number: M020 Degil Sun SPF 30 Sunscreen HOMOSALATE, OCTISALATE, OXYBENZONE,AVOBENZONE, OCTOCRYLENE Degil Safety Products (1989) Inc 16d8d1d0-e531-2a64-e063-6394a90a5b9c 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Alabaster TITANIUM DIOXIDE Chantecaille Beaute Inc e1c562b8-76c0-4c6e-9276-900784c8639e 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Wheat TITANIUM DIOXIDE Chantecaille Beaute Inc 89f19f7a-60e3-4080-a49a-a4eb3e6c27de 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Aura TITANIUM DIOXIDE Chantecaille Beaute Inc de441a6c-55e3-4b11-afb3-d7db3c6971f0 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Bliss TITANIUM DIOXIDE Chantecaille Beaute Inc 16d9e226-7694-922a-e063-6394a90aea85 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Glow TITANIUM DIOXIDE Chantecaille Beaute Inc f868fe4f-4c10-4f0f-9f1d-008f06774408 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Nude TITANIUM DIOXIDE Chantecaille Beaute Inc cb8feddc-ae98-42ea-ad1e-583dcacfa5d9 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Opaline TITANIUM DIOXIDE Chantecaille Beaute Inc 1c918b4b-763b-48bf-9ae3-661eabafee16 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Tan TITANIUM DIOXIDE Chantecaille Beaute Inc fdf05545-5a21-4238-b0d3-e3fcdfe866ff 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Topaz TITANIUM DIOXIDE Chantecaille Beaute Inc 2012f671-7889-4e29-b70f-215cbc9dbdc7 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Vanilla TITANIUM DIOXIDE Chantecaille Beaute Inc 7133c47d-ed1c-43e9-8cdf-42f7b2f215f5 2024-04-24 Warnings Exact identifier application number: M020 Eco Lips PlantPod Sunscreen Lip Balm Vanilla SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Eco Lips. Inc. fd8edc49-762a-b718-e053-6394a90a65f5 2024-04-23 Warnings Exact identifier application number: M020 SKINPERFECT PRIMER SPF30 ZINC OXIDE Dermalogica, LLC. 692f9cda-eb6c-431f-a575-3778c6e12e3b 2024-04-23 Warnings Exact identifier application number: M020
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