Home NDC 61354-081 Cream
Product NDC 61354-081
11-digit product format 613540081
Labeler code 61354
Product ID 61354-081_e715df51-25f7-298a-e053-2a95a90a0464
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 2022-08-25
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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 Cream 100 mg in 1 TUBE LOTION 100 1 61354-081-01 Cream 1 in 1 CARTON LOTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-081 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220827_e715df51-25f6-298a-e053-2a95a90a0464.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 226 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sum 37 Micro Active Daily Moisture Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LG HOUSEHOLD & HEALTH CARE LTD. 2eea94e1-2409-8ad6-e063-6294a90a5df8 2025-03-03 Warnings Exact identifier application number: M020 Sun Defense Minerals (Fair) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e21c9f9-acf8-997b-e063-6394a90ada3f 2025-03-01 Warnings Exact identifier application number: M020 Sun Defense Minerals (Medium) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e232e8d-4274-68bc-e063-6394a90a942b 2025-03-01 Warnings Exact identifier application number: M020 Sun Defense Minerals (Deep) ZINC OXIDE Eminence Organic Skin Care 2e23d463-fbc1-5718-e063-6294a90a7272 2025-03-01 Warnings Exact identifier application number: M020 Sun Defense Minerals (Deep) ZINC OXIDE Eminence Organic Skin Care 2e24391f-4982-efae-e063-6394a90accaa 2025-03-01 Warnings Exact identifier application number: M020 FRUDIA Blueberry Hydrating Air Fit Sunscreen OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE WELCOS CO.,LTD. 8b2a1baa-e528-48d6-9cd8-c3cb55e0641b 2025-02-28 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 MINERAL ZINC OXIDE SPF Ventures, LLC 2f1b5454-8bf5-b447-e063-6394a90a743a 2025-02-27 Warnings Exact identifier application number: M020 Clear Defense SPF 45 ZINC OXIDE, OCTINOXATE Private Label Skin Care d681d92f-3501-4fca-b629-096341f20ab1 2025-02-27 Warnings Exact identifier application number: M020 HA Physical Tint SPF 44 ZINC OXIDE, TITANIUM DIOXIDE Private Label Skin Care a5e19d77-703e-41e0-9a02-19227dc6c819 2025-02-27 Warnings Exact identifier application number: M020 Physical Daily Defense Broad Spectrum Sunscreen SPF 40 ZINC OXIDE Private Label Skin Care 18444581-66a4-4eda-a8df-627fa3b4b98a 2025-02-26 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILL ZINC OXIDE/TITANIUM DIOXIDE SPF Ventures, LLC 2f069114-9ca8-aed4-e063-6394a90a46d8 2025-02-26 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 230 N Melaleuca Inc. 2f133abb-cad2-2ac8-e063-6294a90aa480 2025-02-26 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 KIDS MINERAL ZINC OXIDE SPF Ventures, LLC 2f17b5fe-44da-964b-e063-6394a90ae699 2025-02-26 Warnings Exact identifier application number: M020 Sun Defense Minerals (Tan) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2efb73a6-601d-61a4-e063-6294a90af825 2025-02-25 Warnings Exact identifier application number: M020 Rida Hair Research Institute AVOBENZONE,OCTISALATE,OCTOCRYLENE Rida LLC ece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca 2025-02-25 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 70 Peach Blossom AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed217698-f552-677e-e053-2995a90acb0a 2025-02-25 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 30 Tropical Coconut AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed0f8249-aba8-b67c-e053-2a95a90af7eb 2025-02-25 Warnings Exact identifier application number: M020 Hydro Essence Broad Spectrum Sunscreen SPF 40 ZINC OXIDE, OCTINOXATE Private Label Skin Care f176c1b1-f539-417f-98b5-69d99365f2f2 2025-02-25 Warnings Exact identifier application number: M020 Sun Defense Minerals (Tan) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2ee82379-6609-fd8e-e063-6294a90acf6c 2025-02-24 Warnings Exact identifier application number: M020 Vacation SPF 50 Classic AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vacation Inc. f2780cb5-063c-10d3-e053-2995a90a8576 2025-02-24 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 61354-081-01 61354008101 1 TUBE in 1 CARTON (61354-081-01) > 100 mg in 1 TUBE 1 tube 2022-08-25 0000-00-00 No No Current