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 106 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 3894273d-c5e7-4ea8-9956-5ac3d88b7420 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3C OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 8b63133c-150a-4290-a7fb-56b0dc42a8ce 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ae7ca27f-7806-452e-9935-4a4abc37a5eb 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 9bbacc16-8d60-4170-a3cb-0bfb748177a2 2025-12-19 Warnings Exact identifier application number: M020 Perricone MD NEUROPEPTIDE Rejuvenating Moisturizer SPF 25 Broad Spectrum SPF 25 ZINC OXIDE THG Beauty USA LLC 464e2d4e-9837-e6d5-e063-6294a90a726a 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 FAIR TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 4327c775-e179-47d8-9b4b-945fc1b0b234 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 LIGHT TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 0f3a9b6a-b1b2-4d69-88de-6f22c17a4844 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TAN TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 5cce7646-d9f5-454b-b7a8-a5a6b62a1916 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICH TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 7da16dd7-c26c-4c4e-905f-3bbb878022cc 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM-TAN TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 85f3dd47-4f1f-4fa3-a171-4f4b7707191c 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC ILLUMINATION FAIR TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 4e5764f3-9d9e-460b-ab1e-36f280281dec 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC e700dc6e-e7ae-47ee-9974-430bfd045b4f 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TAN TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC c7924d60-03fb-4a4d-b718-e324f6f1f65f 2025-12-19 Warnings Exact identifier application number: M020 THE GOLDEN GUARD Browning Radiance Gel Suncare for Body AVOBENZONE, OCTISALATE, AND OCTOCRYLENE Dune Suncare, Inc. 4654c417-faa3-23c6-e063-6394a90a2b5a 2025-12-19 Warnings Exact identifier application number: M020 THE MINERAL MELT Invisible Mineral Suncare for Face TITANIUM DIOXIDE, ZINC OXIDE Dune Suncare, Inc. 46557319-7546-e712-e063-6394a90a3cfe 2025-12-19 Warnings Exact identifier application number: M020 Sand Cloud Mineral Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Sand Cloud Holdings, LLC ff477199-9b01-fc90-e053-6294a90a5102 2025-12-19 Warnings Exact identifier application number: M020 Sand Cloud Mineral Sunscreen For Face TITANIUM DIOXIDE AND ZINC OXIDE Sand Cloud Holdings, LLC ff2346c6-d911-87b3-e053-6394a90ac6f8 2025-12-19 Warnings Exact identifier application number: M020 Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - Shell TITANIUM DIOXIDE, ZINC OXIDE Rodan & Fields 12c63195-8707-4df0-a4d3-6f31c543db7a 2025-12-19 Warnings Exact identifier application number: M020 EltaMD UV SPF35 OCTINOXATE, ZINC OXIDE SUNSCREEN CP Skin Health Group, Inc 3029d6ed-a60b-4789-a567-d09b12d76bf4 2025-12-19 Warnings Exact identifier application number: M020 OUHOE Universal Colored Moisturizer TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 4634fdcd-6f0e-25ca-e063-6294a90a196e 2025-12-18 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