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 163 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Solarium Daily Essentials Luminizing Glow Drops ZINC OXIDE Solarium Brands LLC 302a4efe-d429-b1c4-e063-6294a90a073d 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Lip Oil Dusty Rose ZINC OXIDE Solarium Brands LLC 2a934860-02a7-a463-e063-6294a90aa446 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Lip Oil Scarlet Bloom ZINC OXIDE Solarium Brands LLC 2a931e78-e58c-e216-e063-6294a90a3e49 2025-11-17 Warnings Exact identifier application number: M020 Morning Person Daily Repair Protect Moisturizer ZINC OXIDE Morning Person Beauty 33a20264-9216-154e-e063-6294a90a3c8b 2025-11-17 Warnings Exact identifier application number: M020 Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUS HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDE Edgewell Personal Care Brands LLC c780d5cf-8388-42e0-e053-2a95a90a7c04 2025-11-17 Warnings Exact identifier application number: M020 Hell on Earth The Resistance Daily Face Moisturizer TITANIUM DIOXIDE, ZINC OXIDE Hell on Earth 38debebf-1e12-09f3-e063-6294a90a9a2a 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT PROTECTION PLUS VITAMINS FACE SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC e64de59e-b8db-522e-e053-2a95a90ac458 2025-11-17 Warnings Exact identifier application number: M020 Credo Skin Solar Limits Serum ZINC OXIDE Eco-Chic LLC 395dc8eb-978b-a18f-e063-6294a90a2207 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 05ce5223-3fb2-4c27-e063-6394a90a8a8f 2025-11-17 Warnings Exact identifier application number: M020 Credo Follain Daily Mineral Sunscreen ZINC OXIDE Eco-Chic LLC 395d6ad4-04ae-8945-e063-6294a90ad87c 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 0c7b7571-7317-98bc-e063-6294a90aa29f 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 22717885-d06b-ed2d-e063-6294a90a2118 2025-11-17 Warnings Exact identifier application number: M020 Riversol Daily Glow Mineral Tinted ZINC OXIDE Riversol Skincare 3bc7d94e-e312-a9ca-e063-6394a90a4338 2025-11-17 Warnings Exact identifier application number: M020 Riversol Daily Glow Mineral Untinted ZINC OXIDE Riversol Skincare 3bc78cbb-83e3-7fd6-e063-6394a90a5260 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 236d2dce-70aa-66d2-e063-6394a90aff52 2025-11-17 Warnings Exact identifier application number: M020 Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Dusky Pink 8g ZINC OXIDE NAKED SUNDAYS PTY LTD 2f441311-b41c-d4e8-e063-6394a90a697a 2025-11-17 Warnings Exact identifier application number: M020 Woro Beauty SPFortless TITANIUM DIOXIDE, ZINC OXIDE Woro Beauty 3d86ef02-c947-2791-e063-6394a90a42cc 2025-11-17 Warnings Exact identifier application number: M020 Dolce Glow Body Balm ZINC OXIDE Dolce Glow, Inc. 43cea601-a6c0-4de3-e063-6294a90aa8eb 2025-11-17 Warnings Exact identifier application number: M020 Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kao USA Inc. 0c92dfc3-782d-e11f-e063-6394a90a2f8a 2025-11-17 Warnings Exact identifier application number: M020 Sunscreen SPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Broder Bros Prime Line 0a360f87-76cf-e6a7-e063-6294a90a07fb 2025-11-17 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