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 2027-12-31
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 2027-12-31 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 318 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE The Honest Company, Inc. c172d584-7cb6-a078-e053-2995a90ac78f 2023-12-05 Warnings Exact identifier application number: M020 EltaMD UV Sheer ZINC OXIDE AND OCTOCRYLENE SUNSCREEN CP Skin Health Group, Inc. 2564e811-70f5-4d00-be8e-686b55e31630 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c1720cff-a897-68cb-e053-2995a90a30b6 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c12272c3-d4ed-2212-e053-2995a90add37 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c12272c3-d4f0-2212-e053-2995a90add37 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c1228ca6-8fb4-5964-e053-2a95a90a30ca 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c12292a8-c98f-eb27-e053-2a95a90a9bbc 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE The Honest Company, Inc. c172d22a-0315-8e84-e053-2995a90a30b5 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE The Honest Company, Inc. c172cabe-faab-6458-e053-2995a90aef66 2023-12-05 Warnings Exact identifier application number: M020 Sea Clearly Translucent Gel Sunscreen BS SPF 50 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Allure Labs 0bb4ec66-64ba-9583-e063-6394a90ac512 2023-12-04 Warnings Exact identifier application number: M020 Clearly Zinq Mineral Gel Sunscreen BS SPF 60 ZINC OXIDE Allure Labs 0bb7f0a4-13df-7734-e063-6294a90a242b 2023-12-04 Warnings Exact identifier application number: M020 RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skin TITANIUM DIOXIDE, ZINC OXIDE Rodan & Fields b7401ff8-ca47-4c74-813c-99c5f28c0b6d 2023-12-04 Warnings Exact identifier application number: M020 Eminence Bright Skin Moisturizer SPF 40 Sunscreen ZINC OXIDE Eminence Organic Skin Care 4f2ba93d-ec19-40c1-b4ca-53898841f55b 2023-12-02 Warnings Exact identifier application number: M020 Lilikoi Mineral Defense Sport Sunscreen SPF 30 ZINC OXIDE Eminence Organic Skin Care Ltd. 5375522a-17e3-48a1-8248-dd811c3823bf 2023-12-02 Warnings Exact identifier application number: M020 Eminence Lilikoi Daily Defense Moisturizer SPF 40 Sunscreen ZINC OXIDE Eminence Organic Skin Care edc9972a-affd-4099-aec1-3549a07fa83c 2023-12-02 Warnings Exact identifier application number: M020 Perbelle CC SPF43 UVA UVB Broad Spectrum TITANIUM DIOXIDE Perbelle Cosmetics Global Ltd. b5e2724e-9806-5bcc-e053-2a95a90a0508 2023-12-01 Warnings Exact identifier application number: M020 A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEA AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE ORIGINS NATURAL RESOURCES INC. abd8b302-a01c-478d-919a-22e686cb88da 2023-12-01 Warnings Exact identifier application number: M020 SHADE and ILLUMINATE SOFT RAD PRMR SPF OCTINOXATE,OCTISALATE,ZINC OXIDE TOM FORD BEAUTY DIST eac7d416-c243-4647-e053-2a95a90abcb7 2023-12-01 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c1228d15-a157-6989-e053-2995a90a44ea 2023-12-01 Warnings Exact identifier application number: M020 CAO Cosmetic Lip Sunscreen SPF 30 AVOBENZONE, OCTOCRYLENE S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED d912b9e9-f351-e2b0-e053-2a95a90a9ca2 2023-11-30 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