Home NDC 61354-085 Cream
Product NDC 61354-085
11-digit product format 613540085
Labeler code 61354
Product ID 61354-085_e776d7ee-d30e-e3dd-e053-2995a90a8cfa
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 61354-085-01 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 61354-085-01 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 61354-085-01 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 61354-085-01 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 61354-085-01 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 61354-085-01 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 61354-085-01 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 61354-085-01 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 61354-085-01 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 61354-085-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-085-01 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 61354-085 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e776de6a-f82d-73c9-e053-2a95a90a09a6.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 184 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Sheer Shimmer 10 AVOBENZONE, HOMOSALATE, OCTOCRYLENE Kenvue Brands LLC 16ac7877-8dfd-3d69-e063-6394a90a5a8a 2025-09-08 Warnings Exact identifier application number: M020 COLLAGEN GLOW MINERAL SUNSCREEN SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 388fb3db-29d2-bb29-e063-6394a90a4efb 2025-09-08 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 15N Light Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 8d76a963-bdf5-44a1-b1d6-27d1a3aaa1ae 2025-09-08 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 16N Light Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L d279693f-2254-4f3c-a121-144f95f9f25d 2025-09-08 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 12N Light Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 7f007540-8271-4d85-9d1e-b2b273ca05f8 2025-09-08 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 17W Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 5198d3df-ffa8-45eb-93d1-11e9f3961b92 2025-09-08 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 18N Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L a82d85c4-c6ef-4083-b67a-2d6b0e8fc10d 2025-09-08 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 19W Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 4ee6cac6-f649-436c-ada2-e024b86add69 2025-09-08 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 24N Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L edd4e8c3-b47a-4cfe-bf20-e856edb76e21 2025-09-08 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 21W Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 457f0a5c-c543-44f8-82d6-1096a8aab984 2025-09-08 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 22N Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 1452ffc4-a83f-472f-ae70-9e1002f88945 2025-09-08 Warnings Exact identifier application number: M020 Ocean Potion Suncare 50 Continuous Sunscreen Scent of Sunshine AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE GNL BRANDS INTERNATIONAL, LLC 3e518d8a-f52b-4ae1-e063-6394a90aaa1e 2025-09-08 Warnings Exact identifier application number: M020 Ocean Potion Suncare 50 Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE GNL BRANDS INTERNATIONAL, LLC 3c5a624a-8844-b782-e063-6294a90a478c 2025-09-08 Warnings Exact identifier application number: M020 PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5 ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDE Hangzhou Jingshen Trading Co., Ltd. 3dbb07e2-971c-284d-e063-6294a90a437f 2025-09-06 Warnings Exact identifier application number: M020 PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6 ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDE Hangzhou Jingshen Trading Co., Ltd. 3e069cb2-c4c5-abf5-e063-6394a90a56b0 2025-09-06 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 2C Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 761ce50c-2bf5-4ed0-91ac-9c47f8790ddb 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 3W Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 2781b921-eb0d-4270-addf-47301577b28c 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 5N Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 893434a1-72b8-4f0f-bfaa-2c9d775d7e27 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 7N Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 199d97a2-d32b-45ab-a43d-30522b0ca596 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 10N Light Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 638eafb5-08a8-425f-893f-d6609b868e2b 2025-09-05 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 61354-085-01 61354008501 1 TUBE in 1 CARTON (61354-085-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current