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 129 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Age Defying Sunscreen ZINC OXIDE GINAMARIE Products 35837cf7-91e5-f9ec-e063-6394a90aa91e 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen Face plus Body ZINC OXIDE KS Esthetics, LLC 390a4d8d-b47f-0d9a-e063-6394a90a9b53 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen Tinted Zinc Oxide ZINC OXIDE KS Esthetics, LLC 3909e657-97a5-dd3c-e063-6394a90a10eb 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen non tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 36608832-22d8-bc76-e063-6394a90abac6 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen, tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 3660af9e-d60f-c33e-e063-6394a90a3a05 2025-12-12 Exact identifier application number: M020 Hydrating Antioxidant Sunscreen tinted ZINC OXIDE KRISTI REDD ESTHETICS 366149e2-b03c-e798-e063-6394a90a6a1d 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen, tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 3660e701-1373-eef4-e063-6394a90a6140 2025-12-12 Exact identifier application number: M020 Hydrating Antioxidant Sunscreen tinted ZINC OXIDE KRISTI REDD ESTHETICS 3661251d-b907-8df6-e063-6294a90a1c73 2025-12-12 Exact identifier application number: M020 sheer tinted sunscreen TITANIUM DIOXIDE, ZINC OXIDE SARA ELIZABETH SKINCARE 3b177c49-ed8c-42b9-e063-6294a90a82c6 2025-12-12 Warnings Exact identifier application number: M020 Canopy Untinted ZINC OXIDE BORREGO SPRINGS SKINCARE LLC 35824cd5-0036-7886-e063-6394a90ae678 2025-12-12 Exact identifier application number: M020 Canopy SPF 40 Tinted ZINC OXIDE BORREGO SPRINGS SKINCARE LLC 358319c5-ae35-cb3b-e063-6394a90ad77f 2025-12-12 Exact identifier application number: M020 Non-Tinted Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3581ab49-ef55-3743-e063-6394a90a3bd5 2025-12-12 Exact identifier application number: M020 Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3581cf33-3520-42f7-e063-6394a90a6f93 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen For Face and Body ZINC OXIDE Skin Philosophy by Kelly 358248e6-16cf-6f9b-e063-6394a90a55d7 2025-12-12 Exact identifier application number: M020 Replenishing Mineral Sunscreen ZINC OXIDE Skin Philosophy by Kelly 35828e76-66db-49de-e063-6294a90a2b99 2025-12-12 Exact identifier application number: M020 Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3592b2c7-295a-7c60-e063-6394a90a387b 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen For Face and Body ZINC OXIDE Skin Philosophy by Kelly 3592fd5f-13d1-9aec-e063-6394a90abd67 2025-12-12 Exact identifier application number: M020 Replenishing Mineral Sunscreen ZINC OXIDE Skin Philosophy by Kelly 359371f2-2407-e1a1-e063-6294a90a2165 2025-12-12 Exact identifier application number: M020 Non Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 397fc3c9-9d30-adcf-e063-6394a90ac761 2025-12-12 Exact identifier application number: M020 Non Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 39800bf1-e01a-e1c8-e063-6294a90a53bf 2025-12-12 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