Home NDC 58892-336 TiZO2
Product NDC 58892-336
11-digit product format 588920336
Labeler code 58892
Product ID 58892-336_509cad98-0322-2a0a-e063-6294a90a6ea9
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Fallien Cosmeceuticals Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-04-27
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 40.7; 85.4 mg/mL; mg/mL
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 · 50 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58892-336-45 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58892-336-45 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58892-336-45 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58892-336-45 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58892-336-45 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58892-336-45 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58892-336-45 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58892-336-45 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58892-336-45 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58892-336-45 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58892-336-45 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58892-336-50 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58892-336-45 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58892-336-50 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58892-336-45 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58892-336-50 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58892-336-45 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58892-336-50 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58892-336-45 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 58892-336-45 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 58892-336-45 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 58892-336-45 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58892-336-45 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58892-336-45 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58892-336-45 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58892-336-45 I Inactivated by FDA 110d247fa046…a55b01930146…
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 TiZO2
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 40.7 mg/mL TITANIUM DIOXIDE 85.4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Titanium Dioxide ACTIVE INGREDIENT 15FIX9V2JP SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Titanium Dioxide ACTIVE MOIETY 15FIX9V2JP SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Cyclomethicone 5 INACTIVE INGREDIENT 0THT5PCI0R SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-336 TIZO2 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 4 Current NDC, Legacy NDC, 2 package rows 20241004_43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a.zip 58892-336 SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Current NDC, Legacy NDC, 2 package rows 20121208_30468afc-9616-4765-b046-12e97a0a7827.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 12 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Juice Body Mist Sunscreen SPF30 - Cotton Candy Skies PARADISO AVOBENZONE, HOMOSALATE, OCTISALATE Koco Life LLC 568083ff-0da9-7f14-e063-6394a90a4301 2026-07-13 Warnings Exact identifier application number: M020 Sun Juice Body Mist Sunscreen SPF30 - Vanilla Breeze PARADISO AVOBENZONE, HOMOSALATE, OCTISALATE Koco Life LLC 3cc62c97-70c5-17f7-e063-6394a90abe25 2026-07-13 Warnings Exact identifier application number: M020 Norwex Lip Glaze Broad Spectrum SPF 30 Rose ZINC OXIDE Norwex Usa, Inc. 565feded-8e25-e628-e063-6294a90aee48 2026-07-11 Warnings Exact identifier application number: M020 PoutScreen Lip Treatment Lemon Meringue AVOBENZONE, OCTINOXATE, OCTOCRYLENE NAKED SUNDAYS PTY LTD 563e3ab9-4ee2-279c-e063-6294a90a7cf1 2026-07-10 Warnings Exact identifier application number: M020 INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWN ZINC OXIDE COSMAX USA, CORPORATION 5643a73d-757c-702d-e063-6294a90a2c12 2026-07-10 Warnings Exact identifier application number: M020 INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTE ZINC OXIDE COSMAX USA, CORPORATION 5643d655-e335-5643-e063-6394a90a483a 2026-07-10 Warnings Exact identifier application number: M020 MUSELY DAYCREAM SPF40 ZINC OXIDE COSMAX USA, CORPORATION 56443156-3edb-a643-e063-6394a90adf9f 2026-07-10 Warnings Exact identifier application number: M020 Hello Sun Silky Glow Broad Spectrum SPF40 ZINC OXIDE Cosmax USA, Corporation 56445f2d-8e5a-34eb-e063-6294a90ae26e 2026-07-10 Warnings Exact identifier application number: M020 Hello Kitty Fun Broad Spectrum SPF 40 ZINC OXIDE Cosmax USA Corporation 5644854e-18d6-617d-e063-6294a90ab3e7 2026-07-10 Warnings Exact identifier application number: M020 VERSED DAILY SUNSCREEN SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE COSMAX USA, CORP 5644ca1e-9032-d3fb-e063-6394a90a961e 2026-07-10 Warnings Exact identifier application number: M020 Hello Kitty Sunny Days Broad Spectrum SPF 40 ZINC OXIDE Cosmax USA Corporation 5644855d-f864-e07b-e063-6394a90a5148 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 ZINC OXIDE COSMAX USA, CORP 5644d49f-08b9-e806-e063-6294a90a80f9 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT NEUTRAL ZINC OXIDE COSMAX USA, CORP 564682e5-1051-9936-e063-6394a90abe1d 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT WRM ZINC OXIDE COSMAX USA, CORP 5646e069-5461-12c5-e063-6294a90abacb 2026-07-10 Warnings Exact identifier application number: M020 Protect Sport Sunscreen BROAD SPECTRUM SPF 30 Opal Day Spa 564704f2-b26a-d737-e063-6294a90aa6ff 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM NEUTRAL ZINC OXIDE COSMAX USA, CORP 5647162a-610e-2789-e063-6294a90a7549 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM OLIVE ZINC OXIDE COSMAX USA, CORP 56472adb-572d-5a52-e063-6294a90a3cc3 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM COOL ZINC OXIDE COSMAX USA, CORP 56474782-beff-8437-e063-6294a90a8322 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM PEACH ZINC OXIDE COSMAX USA, CORP 564749f3-e820-9003-e063-6294a90a0265 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRAL ZINC OXIDE COSMAX USA, CORP 56477f58-3878-81fa-e063-6294a90a87b7 2026-07-10 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 58892-336-05 58892033605 5 mL in 1 TUBE (58892-336-05) 5 ml 2015-04-27 No No Current 58892-336-15 58892033615 1.5 mL in 1 PACKET (58892-336-15) 1.5 ml 2015-04-27 No No Current 58892-336-45 58892033645 44.4 mL in 1 TUBE 44.4 ml Historical 58892-336-50 58892033650 1 TUBE in 1 CARTON (58892-336-50) / 50 mL in 1 TUBE 1 tube 2015-04-27 0000-00-00 No No Current