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 91 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY ZINC OXIDE Kao USA Inc. 26bcb9cd-bfb5-998c-e063-6394a90ab9d6 2026-01-05 Warnings Exact identifier application number: M020 HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD ZINC OXIDE Kao USA Inc. 26cf1320-aae5-2ea0-e063-6394a90a3be2 2026-01-05 Warnings Exact identifier application number: M020 OZE SUN BONDI ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 47b1aae6-0b86-7d48-e063-6294a90a9ece 2026-01-05 Warnings Exact identifier application number: M020 Hybrid SPF SPF 30 OCTOCRYLENE, OCTISALATE, ZINC OXIDE Topiderm, Inc. 5c99f98c-025c-4886-824f-af968033baf4 2026-01-05 Warnings Exact identifier application number: M020 TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 Plus TITANIUM DIOXIDE HEY HONEY INC. 21187805-fae9-476c-81b0-27ffeb0b9911 2026-01-05 Warnings Exact identifier application number: M020 VEAKSON BEEF TALLOW SUNSCREEN ZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACID Guangdong Aimu Biological Technology Co., Ltd 473c241a-1258-1680-e063-6394a90a7d98 2026-01-04 Warnings Exact identifier application number: M020 HYDRATING SUNSCREEN HYDRATING SUNSCREEN Guangzhou Yapeng Refinement Chemical Co., Ltd. 19a3687b-32b0-7c83-e063-6294a90aaf81 2026-01-04 Warnings Exact identifier application number: M020 Bellas Friends Sunscreen Stick ZINC OXIDE Panergytek Usa Inc 478cbdeb-28e4-fa56-e063-6294a90af124 2026-01-04 Warnings Exact identifier application number: M020 Bellas Friends Roll-on Sunscreen TITANIUM DIOXIDE, ZINC OXIDE PANERGYTEK USA INC 478d46ce-14e8-2231-e063-6394a90a3e27 2026-01-04 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Clear Sunshine ZINC OXIDE Cyberderm Laboratories inc. a8646ee4-5e6e-6cdd-e053-2a95a90aee77 2026-01-01 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Strawberry Zinnia ZINC OXIDE Cyberderm Laboratories inc. a888396f-489f-7e7c-e053-2995a90aee5b 2026-01-01 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Watermelon Lily ZINC OXIDE Cyberderm Laboratories inc. a8889754-8e33-4d2a-e053-2995a90a6080 2026-01-01 Warnings Exact identifier application number: M020 OKeeffes Lip Repair AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE The Gorilla Glue Company/O'Keeffe's Company 6805b3e9-77cb-bfee-e053-2991aa0a8d98 2026-01-01 Warnings Exact identifier application number: M020 Walgreens 50 Pina Colada Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY 4978c811-be34-9fc3-e063-6394a90a2d80 2026-01-01 Warnings Exact identifier application number: M020 Unicorn Snot 35 SPF Glitter Spritz rose gold shimmer AVOBENZONE, OCTISALATE, OCTOCRYLENE Jailbreak Toys, Inc. DBA UNICORN SNOT 498b7c1a-e66d-9736-e063-6394a90a4712 2026-01-01 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Day Cream SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BCM Ltd f7d5aa8a-9f4a-426b-ac9d-9690cf0103e0 2026-01-01 Warnings Exact identifier application number: M020 MAUI ISLAND SECRET BROWNING CREME Broad Spectrum Sunscreen SPF 5 ZINC OXIDE Formula 7venz L.L.C. 5f3cdec9-2cc2-4660-827f-d286883d907c 2025-12-31 Warnings Exact identifier application number: M020 SOLARA SUNCARE - GO VACATION GLOW SPF 30 ZINC OXIDE SOLARA SUNCARE, INC. 1f5cb694-f065-7ebc-e063-6394a90a883a 2025-12-31 Warnings Exact identifier application number: M020 SUNSCREEN GLOWING, SPF 30 SUNSCREEN GLOWING LOTION FSA Store Inc 473bcb90-ab7f-170b-e063-6294a90a99d5 2025-12-31 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 05ba5966-f0ff-5360-e063-6294a90a0fc9 2025-12-31 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