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 208 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Reef safe - Baby zinc sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f320c-9144-78b8-e063-6394a90a2e9d 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Zinc Sport sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385ff227-1656-960a-e063-6294a90a913c 2025-06-25 Warnings Exact identifier application number: M020 Thermasun SPF50 Mineral Zinc facial sunscreen ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386ecba0-2f7f-9178-e063-6394a90a44c4 2025-06-25 Warnings Exact identifier application number: M020 Reefsun sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386ec055-4ae7-9d2d-e063-6394a90a83c0 2025-06-25 Warnings Exact identifier application number: M020 SR Active Sheer Zinc Face Stick SPF 50 20.6% ZINC OXIDE Skinresource.md, L.L.C. 29928ab0-4467-57cb-e063-6394a90ac4d3 2025-06-25 Warnings Exact identifier application number: M020 Sun Protection SPF 50 AVOBENZONE 2.9%, HOMOSALATE 4.0%, OCTISALATE 4.9%, OCTOCRYLENE 9.5% Skinresource.md, L.L.C. 2a0c3dd1-4bc0-6664-e063-6294a90af4b3 2025-06-25 Warnings Exact identifier application number: M020 MELAO WHITENING SUNSCREEN TITANIUM DIOXIDE Guangdong Aimu Biological Technology Co., Ltd 1aaf5942-ff13-ee07-e063-6394a90acd28 2025-06-25 Warnings Exact identifier application number: M020 Blooskim BEEF TALLOW SUNSCREEN NON-NANO ZINC OXIDE Guangzhou Haishi Biological Technology Co., Ltd. 384903fa-e739-08b8-e063-6394a90a7653 2025-06-24 Warnings Exact identifier application number: M020 Walgreens SPF 55 Sheer Face Mist Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY f05b45e2-2fcd-631e-e053-2995a90ad334 2025-06-24 Warnings Exact identifier application number: M020 Walgreens SPF 50 Premium Moisturizing Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY 0b2b1ed5-8e53-00f3-e063-6394a90a14f8 2025-06-24 Warnings Exact identifier application number: M020 Walgreens Double Restorative Moisturizer Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY 38569431-56b6-5f56-e063-6394a90ad24f 2025-06-24 Warnings Exact identifier application number: M020 Shade SPF30 Climate Control OCTISALATE, OCTOCRYLENE, ZINC OXIDE Micro Current Technology, Inc. 34080e9c-1637-cf25-e063-6394a90ace76 2025-06-24 Warnings Exact identifier application number: M020 Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Aruba Aloe Balm NV cca65f6a-935f-48d4-a07d-831ab6027db0 2025-06-24 Warnings Exact identifier application number: M020 Reef safe - Hydrating sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385e8966-963d-0814-e063-6394a90a06e3 2025-06-24 Warnings Exact identifier application number: M020 COLLAGEN GLOW MINERAL SUNSCREEN SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD f76a4f0d-e3a6-4bd4-b1ab-09d690976d96 2025-06-23 Warnings Exact identifier application number: M020 LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAMPAGNE 170-N OCTINOXATE, ZINC OXIDE BEL STAR SA f459c27e-e607-47ba-e053-2a95a90a901f 2025-06-22 Warnings Exact identifier application number: M020 BISUTANG Sunscreen BISUTANG SUNSCREEN Guangdong Bisutang Biotechnology Co Ltd 37fdb01b-929e-6a60-e063-6394a90a94e0 2025-06-20 Exact identifier application number: M020 AVON BEYOND GLOW SUN MILK AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LG HOUSEHOLD & HEALTH CARE LTD. 38045f75-42c0-7abb-e063-6294a90a8db6 2025-06-20 Warnings Exact identifier application number: M020 Double Use Compact SPF 15 gold deluxe edition Claire 1-2-3 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Bel Star S.A. (Colombia) b3747373-ef67-89ff-e053-2995a90afcde 2025-06-20 Warnings Exact identifier application number: M020 LBEL DIVINE Double Use compact SPF 15 gold deluxe edition Obscure 8-9 ZINC OXIDE, TITANTIUM DIOXIDE, OCTINOXATE Bel Star S.A. (Colombia) b5e47c63-7e82-34fc-e053-2a95a90a767c 2025-06-20 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