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 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 58892-336-05 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