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 158 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alba Botanica Sheer Mineral SPF30 ZINC OXIDE The Hain Celestial Group, Inc. 0cf9361f-f292-6429-e063-6294a90add0e 2025-11-26 Warnings Exact identifier application number: M020 ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE ZO Skin Health, Inc. ec8386f2-9cb7-40f4-e053-2995a90ac2d8 2025-11-26 Warnings Exact identifier application number: M020 WOODSLEEP Tallow Sunscreen TITANIUM DIOXIDE Shantou Woodsleep Biotechnology Co., Ltd. 330a9f2e-7ce1-f83f-e063-6394a90a184a 2025-11-26 Warnings Exact identifier application number: M020 WOODSLEEP Tallow Sunscreen TITANIUM DIOXIDE Shantou Woodsleep Biotechnology Co., Ltd. 33cdde09-e7ee-e003-e063-6394a90a8762 2025-11-26 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 44718c3c-b081-bcfb-e063-6394a90a3786 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4472cc1e-6b34-388b-e063-6394a90ac7b6 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4472ef69-8992-fcab-e063-6294a90a6b90 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 44732f89-8ac3-8c5d-e063-6394a90aba73 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 447347d6-b8a3-7338-e063-6294a90abbf9 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4473c4cc-f8b5-4a92-e063-6394a90ae690 2025-11-25 Warnings Exact identifier application number: M020 salmon colored sunscreen SALMON COLORED SUNSCREEN Guangzhou Fantesy Biotechnology Co.,Ltd 4477964b-28f3-a371-e063-6294a90a4230 2025-11-25 Warnings Exact identifier application number: M020 Safe Sea SPF 50 Mineral ZINC OXIDE Nidaria Technology Ltd. f6cf9454-552b-486e-a38b-ab3c183b24a1 2025-11-24 Warnings Exact identifier application number: M020 Safe Sea SPF 30 ZINC OXIDE Nidaria Technology Ltd. 91bf07ed-0be4-43c9-b5f3-4e8eb892bca5 2025-11-24 Warnings Exact identifier application number: M020 Olay Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15 OCTINOXATE AND ZINC OXIDE The Procter & Gamble Manufacturing Company 5904baa8-3070-1d77-e053-2a91aa0a6852 2025-11-24 Warnings Exact identifier application number: M020 it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA, Inc. 86eea4df-4191-4e05-9f05-4a98ef8c2a4d 2025-11-24 Warnings Exact identifier application number: M020 Cetaphil Sun Tinted Face SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Galderma Laboratories, L.P. 22413f93-7219-4726-b741-2392e576b34a 2025-11-24 Warnings Exact identifier application number: M020 VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15 ZINC OXIDE AND TITANIUM DIOXIDE Kingdom Animalia, LLC DBA Hourglass Cosmetics 28e23498-953f-47c0-838c-bbf0e858d903 2025-11-24 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 203c9d86-45d7-efcc-e063-6394a90acefb 2025-11-23 Warnings Exact identifier application number: M020 Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 615c5349-7fff-4145-9d65-1687247163be 2025-11-21 Warnings Exact identifier application number: M020 Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Face SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 3cee59ad-f5e1-487d-b9cc-597664c62dac 2025-11-21 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