Home NDC 58892-339 TiZO Tinted Lip Protection SPF 45
Product NDC 58892-339
11-digit product format 588920339
Labeler code 58892
Product ID 58892-339_669e250a-f426-4dde-9e3a-b2b2cf86c911
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler Fallien Cosmeceuticals, LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 40; 55 mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 58892-339 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58892-339 58892-339-45 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 Tinted Lip Protection SPF 45
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 40 mg/g ZINC OXIDE 55 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58892-339-45 TiZO Tinted Lip Protection SPF 45 1 in 1 CARTON STICK 1 3 58892-339-45 TiZO Tinted Lip Protection SPF 45 4.5 g in 1 TUBE STICK 4.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-339 TIZO TINTED LIP PROTECTION SPF 45 (TITANIUM DIOXIDE, ZINC OXIDE) STICK [FALLIEN COSMECEUTICALS, LTD] 3 Current NDC, Legacy NDC, 2 package rows 20250112_81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2.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 197 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Sun Bum, LLC 3ac48eef-f651-af96-e063-6294a90a501e 2025-08-14 Warnings Exact identifier application number: M020 Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Aruba Aloe Balm NV 6a398dad-2fb9-4cdb-86c5-2a392b88f29b 2025-08-13 Warnings Exact identifier application number: M020 SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40 ZINC OXIDE ALL THE RAJE, LLC 9ffbd53b-1295-42b4-9cd5-18cbb75921d0 2025-08-13 Warnings Exact identifier application number: M020 MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, Bistre ZINC OXIDE Power Beauty Co. 2e6eac42-0b70-44ea-e063-6294a90a49f8 2025-08-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE/OCTOCRYLENE/OXYBENZONE Edgewell Personal Care Brands LLC 3c414e9b-6c3e-2c8d-e063-6394a90af4a6 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Baby Mineral Sunscreen SPF 40 ZINC OXIDE Eleeo Brands LLC 3c443347-0134-8c87-e063-6294a90a8046 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Baby Face Mineral Sunscreen Stick SPF 40 ZINC OXIDE Eleeo Brands LLC 3a22f0b9-2d6d-6230-e063-6294a90adf31 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40 ZINC OXIDE Eleeo Brands LLC 3c4567d6-879e-f995-e063-6394a90a319f 2025-08-13 Warnings Exact identifier application number: M020 Silk Screen TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c457455-b9b1-546b-e063-6294a90a41f6 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Tinted Mineral Sunscreen SPF 40 ZINC OXIDE Eleeo Brands LLC 3c455d29-df4e-f4d5-e063-6394a90a97ba 2025-08-13 Warnings Exact identifier application number: M020 Baby Bum Mineral 50 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3c470ff8-37d6-a729-e063-6294a90aa525 2025-08-13 Warnings Exact identifier application number: M020 Sun Bum 50 Mineral Sunscreen 1 OZ ZINC OXIDE Sun Bum, LLC 3c483d04-8942-5269-e063-6294a90a3881 2025-08-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE/OCTOCRYLENE/OXYBENZONE Edgewell Personal Care Brands LLC 3c49c623-47c6-4dc9-e063-6294a90a0096 2025-08-13 Warnings Exact identifier application number: M020 100% MINERAL SUNSCREEN 100% MINERAL SUNSCREEN Guangzhou Pallas Cosmetics Co.,Ltd. 3c4a3b41-9183-3835-e063-6394a90aea61 2025-08-13 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 FAIR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 4443d4e6-bdc9-4547-9189-e94e9e0bdd2d 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC Red Correct Color Correcting SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L a6cd16cc-5fe3-41b5-b724-83e469cd4d5e 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 BRONZE OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 4aa12cf0-0c48-4b40-9c9a-bd50523cce8a 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 MEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 5bdaa149-47aa-40ac-b17a-ea6d29099862 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1dda967c-2d69-8948-e063-6294a90ad2a4 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 24e9a9b8-41ba-123a-e063-6394a90a73cb 2025-08-12 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 58892-339-45 58892033945 1 TUBE in 1 CARTON (58892-339-45) / 4.5 g in 1 TUBE 1 tube 2022-10-01 0000-00-00 No No Current