Home NDC 61354-084 Cream
Product NDC 61354-084
11-digit product format 613540084
Labeler code 61354
Product ID 61354-084_e7763ac1-d05c-7f8f-e053-2995a90a6c15
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-30
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 5 mg/100mg; mg/100mg
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 18 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 product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61354-084-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61354-084-01 I Inactivated by FDA 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 61354-084-01 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 61354-084-01 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 61354-084-01 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 61354-084-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61354-084-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61354-084-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61354-084-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61354-084-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-084-01 Cream 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-084 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e7760899-8b4a-9a2a-e053-2995a90a2fd5.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 253 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nu Skin 180 Degree UV Defense Hydrator SPF 18 OCTINOXATE AND ZINC OXIDE NSE Products, Inc 91a22a5a-87fd-4db0-9183-caebee401304 2024-12-24 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE L'Oreal USA Products Inc aefd7884-6bc3-4b0b-ba36-1f3e8fe49f93 2024-12-23 Warnings Exact identifier application number: M020 Attitude mineral sunscreen tropical SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 56e57ca0-d163-4580-9bca-747acce4d69f 2024-12-23 Warnings Exact identifier application number: M020 (S)UNDERCOVER SPF 50 ZINC OXIDE TUBBY TODD dca478a0-c319-68d8-e053-2a95a90a10fc 2024-12-23 Warnings Exact identifier application number: M020 LOreal Paris Revitalift Triple Power Anti Aging Moisturizer Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc e7bef1da-ea35-4306-b043-73d566a7e6bb 2024-12-23 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 46aa9917-52ac-4c57-afde-366d2d3ca200 2024-12-23 Warnings Exact identifier application number: M020 La Roche Posay Anthelios UV Clear Daily Invisible Broad Spectrum SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 1d115945-fa1b-485b-bf53-44308fd1a630 2024-12-23 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 Sunscreen OCTINOXATE L'Oreal USA Products Inc 7cc920de-c91f-4040-a0b9-ea216d6f9bd7 2024-12-23 Warnings Exact identifier application number: M020 Kids SPF50Plus Mineral Sunscreen Rollerball Totally Tropical ZINC OXIDE AND TITANIUM DIOXIDE KAS Direct LLC dba BabyGanics d3bdda65-bcb4-42d9-84af-d14c7f4421bd 2024-12-23 Warnings Exact identifier application number: M020 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE LOreal USA Products Inc e8539a43-db85-451c-bce8-2c488f3dc40d 2024-12-23 Warnings Exact identifier application number: M020 NYX Professional Makeup Buttermelt Glaze SOFT GLOW SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 HOMOSALATE,OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc 81093d80-dcaf-4555-98b2-48ce7eb84d0c 2024-12-23 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 Sunscreen OCTINOXATE SICOS ET CIE c634eaab-f014-4155-a40b-9030e358ec12 2024-12-23 Warnings Exact identifier application number: M020 Kids SPF50 Plus Mineral Sunscreen Continuous Totally Tropical ZINC OXIDE AND TITANIUM DIOXIDE KAS Direct LLC dba BabyGanics d5ffe993-de8f-4623-a010-9cb8dd70de07 2024-12-23 Warnings Exact identifier application number: M020 CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE LOreal USA Products Inc 8b298516-70df-47ab-834f-51dcde28a43a 2024-12-23 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE SICOS ET CIE 6a14ee23-28c9-4704-8af9-d1c4db0d9256 2024-12-23 Warnings Exact identifier application number: M020 Walgreens SPF 50 Hydrating AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY f347588d-8225-45a7-e053-2995a90ab688 2024-12-22 Warnings Exact identifier application number: M020 Mineral Sunstick ZINC SPF STICK Tubby Todd 29e41fe8-4e17-dbaa-e063-6294a90a4a10 2024-12-22 Warnings Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE SPF 50 Tubby Todd 29e487da-5312-8192-e063-6294a90ad809 2024-12-22 Warnings Exact identifier application number: M020 EcoStick Sunscreen SPF 35 ZINC OXIDE, TITANIUM DIOXIDE Stream2Sea, LLC eba17b7a-5e96-4462-9b71-44c2bc577dce 2024-12-21 Warnings Exact identifier application number: M020 Planet Protecting Sunscreen 30 TITANIUM DIOXIDE Stream2Sea, LLC 89e44c5f-121e-4fdd-b9e0-023909ea32f5 2024-12-21 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 61354-084-01 61354008401 1 TUBE in 1 CARTON (61354-084-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current