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 156 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ATTITUDE Sensitive natural Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4495a302-51b9-3bf2-e063-6294a90a7e4f 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral sunscreen Sprayer SPF 50 Watermelon and coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aa1349-e3f1-9b80-e063-6294a90a0fbd 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral sunscreen SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aaa3c8-ccc4-ae93-e063-6394a90aedc5 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Baby Mineral sunscreen SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aba591-04da-fe09-e063-6394a90a912a 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aba6d7-7989-0637-e063-6394a90a6c8f 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral sunscreen SPF 50 Tropical coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44abca13-8ba9-8925-e063-6294a90accb5 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sensitive natural baby Mineral sunscreen SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44abdfe1-ea6b-a158-e063-6294a90a3eb8 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Watermelon and coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aca1d5-6e0a-def3-e063-6294a90aca26 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral sunscreen SPF 50 Sun kissed vanilla ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aca181-2a90-20a6-e063-6394a90aff47 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral sunscreen Sprayer SPF 50 Sun kissed vanilla ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aa529b-2077-3660-e063-6394a90aa405 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Lip Balm SPF 15 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44ad65f0-ec1d-1638-e063-6294a90a2244 2025-11-28 Warnings Exact identifier application number: M020 HOEGOA Hair Scalp Sunscreen Mineral TITANIUM DIOXIDE Guangzhou Hoegoa Biotechnology Co., Ltd. 44b37930-b302-338c-e063-6394a90a5f7f 2025-11-28 Warnings Exact identifier application number: M020 OCEAURA Glitter Sunscreen TITANIUM DIOXIDE Guangzhou Oceaura Biotechnology Co., Ltd. 44b47284-57cd-2e61-e063-6394a90a5072 2025-11-28 Warnings Exact identifier application number: M020 OUHOE Moisturizing And Translucent Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 34e8e4a6-2782-9a3d-e063-6394a90a84c2 2025-11-27 Warnings Exact identifier application number: M020 OUHOE Protection Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 4272dcef-eda5-1013-e063-6294a90adf38 2025-11-27 Warnings Exact identifier application number: M020 OUHOE Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 42fcc9ed-083c-6582-e063-6394a90ae9e6 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Sun Cream TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305cb87e-450f-840a-e063-6294a90a883f 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Bio Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 349a3d72-9969-855d-e063-6394a90a281c 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Cica Cooling Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305c13af-0843-f478-e063-6394a90a42de 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Quick Sun Stick Protection Bar TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 3578c958-a457-402b-e063-6394a90a7342 2025-11-27 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