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 334 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50 ZINC OXIDE Babo Botanicals, Inc. 088b81e4-76c7-6680-e063-6294a90acb73 2023-10-25 Warnings Exact identifier application number: M020 Cetaphil Hydrating Face Sunscreen SPF 35 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Galderma Laboratories, L.P. e924bfd5-d64d-4918-b57b-7d4da28bd013 2023-10-24 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Ochre L2N1 OCTINOXATE, OXYBENZONE Amway Corp d810bbe7-a889-4737-9a78-d996fec71122 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Chiffon L2C1 OCTINOXATE, OXYBENZONE Amway Corp 0039ca4d-2a0c-4b19-a029-1c080fc292ce 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Sand L2W1 OCTINOXATE, OXYBENZONE Amway Corp 410592f1-57f5-4c17-8162-a0c088f0bf27 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Tawny L3N1 OCTINOXATE, OXYBENZONE Amway Corp e4e61943-ec96-467c-8921-ee531ef4f13d 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Brule L4W1 OCTINOXATE, OXYBENZONE Amway Corp 62ff0eea-b67e-476c-b7f2-0fcaed9dc227 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Cappuccino L5W1 OCTINOXATE, OXYBENZONE Amway Corp 179e5268-8eca-40b7-aa7f-ede221fa9c89 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Walnut L6N1 OCTINOXATE, OXYBENZONE Amway Corp 8a3fcfaa-5bfa-4f77-932f-bfb75628c9c6 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Soleil L3W1 OCTINOXATE, OXYBENZONE Amway Corp 18c11289-9cc0-4a37-a299-ee3c358dbeca 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Caramel L5N1 OCTINOXATE, OXYBENZONE Amway Corp d7cb8e53-a36f-43d1-9918-f5680aafb2c4 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Natural L2N2 OCTINOXATE, OXYBENZONE Amway Corp 01cd84f5-ecd5-4bc3-bb0c-3d5e8ea8a8f5 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Golden L4N1 OCTINOXATE, OXYBENZONE Amway Corp ff9c6565-a942-494f-af8c-557974675db8 2023-10-23 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Plush L3C1 OCTINOXATE, OXYBENZONE Amway Corp 9ca531ae-10b5-4791-b62c-37b99bc1d4ea 2023-10-23 Warnings Exact identifier application number: M020 g and h Protect Body ENSULIZOLE, OCTISALATE, ZINC OXIDE Access Business Group LLC 03768ff4-0c67-48b3-a2f3-321d0a6790e8 2023-10-23 Warnings Exact identifier application number: M020 Artistry Skin Nutrition Multi-Defense UV Protect ZINC OXIDE, TITANIUM DIOXIDE Access Business Group LLC 82623c46-9ec3-4331-a2db-9b8d07fa1817 2023-10-23 Warnings Exact identifier application number: M020 Coconut SPF 15 Broad Spectrum Lip Balm COCONUT SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a75d28eb-2f41-7146-e053-2a95a90a8672 2023-10-23 Warnings Exact identifier application number: M020 Bubblegum SPF 15 Broad Spectrum Lip Balm BUBBLEGUM SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a7590383-661f-5b1e-e053-2995a90a197e 2023-10-23 Warnings Exact identifier application number: M020 Blackberry Smoothie SPF 15 Broad Spectrum Lip Balm BLACKBERRY SMOOTHIE SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a7577d5f-69d8-3f32-e053-2995a90aaba5 2023-10-23 Warnings Exact identifier application number: M020 Breath Fresh SPF 15 Broad Spectrum Lip Balm BREATH FRESH SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a0c3a62f-5c11-c78c-e053-2a95a90a3a58 2023-10-23 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