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 343 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Ivory OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 97e7ece8-a705-4988-ba52-6d3f11573521 2021-12-01 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Chestnut OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 6a44f926-11b4-4bc4-8d5d-721a89c4f0cc 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Hazelnut OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS b58af664-b0fd-4585-8417-7c20954d7aff 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Umber OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 7bbd1334-fae8-4274-b927-a099af764345 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cedar OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 970571f9-3d6b-46ae-a668-745de1911fa2 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Wheat OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 542e1b2e-f63c-466b-b5ac-6c147a0e9dec 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Beige OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 21b65c12-6f67-4053-9508-6b2709cc1fb8 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Beige OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 8ea4c470-ebd5-448e-b72a-ccd1113de0ab 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Honey OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS fd9689a4-21d1-49f0-bf59-b8e1da72cd16 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Dune OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS c23b6a87-8cf9-4be3-8306-2285e7e926c1 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Porcelain OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS a93cb6c6-d7c2-43cc-a2e8-961f896a977e 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Latte OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 32d99955-1593-426b-958e-5dcf689192a3 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Tawny OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 762deb57-754b-46a9-9907-de05e11da178 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Amber OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 3b5366e4-180a-4b98-9524-63601ae9d270 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Vanilla OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e 2021-11-04 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Calico OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 3e67abb5-84a4-4a78-9ea3-9fd57cbeb482 2021-11-04 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Ivory OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 477d79c1-f169-4d0e-a95d-f5e832855f0d 2021-11-04 Warnings Exact identifier application number: M020 Anhydrous SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Owen Biosciences, Inc. 1510cae2-9c8f-45ba-b088-67747af3d30c 2021-07-15 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Tawny OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 3f0480e4-b2c3-962c-e063-6294a90a4f23 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS aa708db4-ad90-49b7-a250-5698e4c7d3d6 2021-07-13 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