Home NDC 61354-082 Cream
Product NDC 61354-082
11-digit product format 613540082
Labeler code 61354
Product ID 61354-082_e724e10c-4f05-b03d-e053-2a95a90a754c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-26
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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 Cream 1 in 1 CARTON LOTION 1 1 61354-082-01 Cream 100 mg in 1 TUBE LOTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-082 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220827_e724e098-f5c9-262a-e053-2995a90a2a02.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 123 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE VIDA HEALTH & WELLNESS LLC 3724cb53-0198-c604-e063-6294a90aa64b 2025-12-15 Exact identifier application number: M020 Untinted Sheer Defense TITANIUM DIOXIDE, ZINC OXIDE Kristina Lerner 35be50b7-a9af-29ee-e063-6394a90a45ba 2025-12-15 Exact identifier application number: M020 Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE VIDA HEALTH & WELLNESS LLC 3724ea3c-b018-c125-e063-6394a90a01f1 2025-12-15 Exact identifier application number: M020 Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE VIDA HEALTH & WELLNESS LLC 37252429-d692-c05a-e063-6294a90a6af6 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen ZINC OXIDE Bodi & Wax, LLC 35d2fbeb-935b-f0a9-e063-6294a90acd79 2025-12-15 Exact identifier application number: M020 BHSkin Sheer Tinted Zinc and Titanium SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Don Mehrabi, M.D. A Professional Medical Corporation 423c7e62-ad50-0dc3-e063-6294a90ad05a 2025-12-15 Warnings Exact identifier application number: M020 Tined Mineral Sunscreen Whipped Mousse TITANIUM DIOXIDE, ZINC OXIDE ESTILO SALON & SPA LLC 3699c107-d063-cc6f-e063-6394a90a6ad4 2025-12-15 Exact identifier application number: M020 BHSkin Sheer Tinted Zinc and Titanium SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Don Mehrabi, M.D. A Professional Medical Corporation 44776529-3aa6-4fa3-b2ce-f624c4cf41bd 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE JMSE Management, LLC 36ec860f-2066-196c-e063-6294a90a2121 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen ZINC OXIDE Bodi & Wax, LLC 35d3262a-1d8d-2afa-e063-6294a90afd49 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen Non-Tinted ZINC OXIDE Bodi & Wax, LLC 35d37c2e-abc0-6bda-e063-6294a90a8fc3 2025-12-15 Exact identifier application number: M020 Tined Mineral Sunscreen Whipped Mousse TITANIUM DIOXIDE, ZINC OXIDE ESTILO SALON & SPA LLC 36999510-88f0-64fc-e063-6294a90a3d09 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen Non-Tinted ZINC OXIDE Bodi & Wax, LLC 35d3486c-c6e8-4d31-e063-6294a90a1219 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Cream ZINC OXIDE ESTILO SALON & SPA LLC 3699f6df-63b8-f255-e063-6394a90af2c4 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Cream ZINC OXIDE ESTILO SALON & SPA LLC 369a5997-7dbe-254d-e063-6394a90a5bef 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE ESTILO SALON & SPA LLC 369a8a99-c755-3c7f-e063-6394a90ac16c 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE ESTILO SALON & SPA LLC 369abc9d-9c20-5397-e063-6394a90a1723 2025-12-15 Exact identifier application number: M020 Sunshade Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37dec631-fdaf-fbdf-e063-6394a90a6c2b 2025-12-15 Exact identifier application number: M020 Matte Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE EDIT EUROSPA, LLC 37527317-0f10-d7e6-e063-6394a90a35a6 2025-12-15 Exact identifier application number: M020 Sunshade Mineral Stick Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37ee31be-bfda-f052-e063-6294a90ac0bb 2025-12-15 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 61354-082-01 61354008201 1 TUBE in 1 CARTON (61354-082-01) > 100 mg in 1 TUBE 1 tube 2022-08-26 0000-00-00 No No Current