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 258 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Everyday Coverage Tinted Sunscreen - Extra Light Tint ZINC OXIDE MV Advanced 7834c649-5f6d-b005-e053-2a91aa0a1084 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Light Tint ZINC OXIDE MV Advanced 783649af-d746-84a3-e053-2991aa0a9e3d 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Medium Tint ZINC OXIDE MV Advanced 783649af-d768-84a3-e053-2991aa0a9e3d 2024-12-12 Warnings Exact identifier application number: M020 Babo SPF 30 Clear Zinc Fragrance Free Sport MINERAL SUNSCREEN Babo Botanicals, Inc. b1a9f76d-0cef-29da-e053-2995a90af34c 2024-12-12 Warnings Exact identifier application number: M020 Babo Baby Face Mineral Sunscreen MINERAL SUNSCREEN Babo Botanicals, Inc. b131664d-1ad2-0a2f-e053-2995a90acbda 2024-12-12 Warnings Exact identifier application number: M020 Babo SPF 30 Clear Zinc Fragrance Free MINERAL SUNSCREEN Babo Botanicals, Inc. b3e40cb0-dbfd-955c-e053-2995a90af848 2024-12-12 Warnings Exact identifier application number: M020 DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 ZINC OXIDE BABOR Cosmetics America Corp 291ec801-ee15-06a4-e063-6294a90ab32b 2024-12-12 Warnings Exact identifier application number: M020 All Calm Clinical Redness Corrector SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 68b95e94-3686-4d11-9952-ec86394376ee 2024-12-12 Warnings Exact identifier application number: M020 Method Men Face with Zinc Oxide Sunscreen ZINC OXIDE Method Products Inc. cce5f8e1-cf40-4524-af2b-1d49309e2809 2024-12-12 Warnings Exact identifier application number: M020 Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 219e2ef4-e977-4527-8999-14b27d5a7a33 2024-12-12 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 50Plus Sunscreen ZINC OXIDE Absolutely Natural 4855c2c7-1516-4857-b103-2eb72a60d5d0 2024-12-11 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Absolutely Natural b6e8f361-fd31-4f21-9095-c5159a826175 2024-12-11 Warnings Exact identifier application number: M020 Walgreens Scar Cream w/SPF 30 AVOBENZONE3%,OCTOCRYLENE10%,OXYBENONE 6% Walgreens cc72c8c5-f3e9-e8e0-e053-2a95a90ae0b0 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L ee9ae84b-c8fc-4a87-8910-46ec8ccfe1a9 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN - BB CREME AU GINSENG DORE SPF 20 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 121aa873-5ca6-426b-8ece-dcb5a9f82a03 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN - CC CREME HIGH DEFINITION SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 3421b9a3-6551-406f-af3a-b3da8a01d2b2 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN CC RED CORRECT SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE Laboratoires M&L 21530925-03b7-40bb-9836-6ee4011c4a79 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 70a5537c-a364-4dae-8ab2-8ca0cbfd11b7 2024-12-11 Warnings Exact identifier application number: M020 ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L b55be8cb-7f21-45b0-bb8f-a60182077ca3 2024-12-11 Warnings Exact identifier application number: M020 I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep Honey ZINC OXIDE AND TITANIUM DIOXIDE Allure Labs dc792777-d8b6-3ebc-e053-2a95a90abc3f 2024-12-11 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