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 76 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 824c5f13-970e-4e9e-8f2a-2a01973d2e59 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b7621ef5-47fc-4ccc-aedd-eac328ace7b9 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 64a29ff8-e24d-4818-9b54-734a0eb2a13f 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 17a0201b-b797-4e65-838f-1ce8d408a020 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 72e2c71a-da1d-497f-a8b7-491cff951c63 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 19d1432a-96b0-4cef-b13e-895dd41b41d6 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5a06c820-ccd8-47ce-8bbf-7e90da92b1de 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 205e195a-fd30-44f7-9294-e701f0f766d6 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5495ff75-0c83-4491-8af7-4aed7a779d7f 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 10bc345d-a5b1-4b70-bfa6-a2d7816904bf 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 30268b6e-d42a-4314-b82f-24f9e81cca2a 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 545c962f-2a59-4d94-8fef-ebdba4127f42 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 17c9226b-459c-42fe-ac50-7e26db6b49af 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af6 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior bf323e10-5479-44b3-b4b9-b8ca6b0f7688 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 2d6a5133-b847-4ecf-8c33-1cb05aca6b91 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 275be888-2c52-43ed-846a-55525002edcd 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c73576a6-dbab-4205-add5-876a060b5022 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 4ae761ac-df06-4913-a8bf-8ca1be32b5b7 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 72c45120-6997-4250-b9b4-1cdb762efe1a 2026-01-16 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