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 169 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Peach Shimmer Sunbeam AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE e.l.f. Cosmetics, Inc. f818f524-0263-4f89-b4f3-4dd83d688e7e 2025-11-07 Warnings Exact identifier application number: M020 e.l.f Invisible Sunscreen SPF 35 AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE e.l.f. Cosmetics, Inc c2af5591-04df-4958-901e-dbe11698b844 2025-11-07 Warnings Exact identifier application number: M020 e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush Much ZINC OXIDE e.l.f. Cosmetics, Inc. 53d64042-f9ef-494d-a347-490c6a3c49b8 2025-11-07 Warnings Exact identifier application number: M020 e.l.f. Suntouchable Invisi SPF 50 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f cosmetics,Inc. 547eac8c-492e-4a6b-ac58-4f0d1e0ccb3d 2025-11-07 Warnings Exact identifier application number: M020 e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my Jam ZINC OXIDE e.l.f. Cosmetics, Inc. b7d56015-4734-4ce4-b40d-64236df810e3 2025-11-07 Warnings Exact identifier application number: M020 elf Sun Boss Gloss SPF 25 Sunscreen Peachy Kween ZINC OXIDE e.l.f. Cosmetics, Inc. 4d9784b6-c54d-483d-a5ba-c557a05300ec 2025-11-07 Warnings Exact identifier application number: M020 ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 ON THE GLOW ZINC OXIDE In The Pynk LLC 13badac4-e310-9589-e063-6394a90ab06b 2025-11-07 Warnings Exact identifier application number: M020 ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 GOLDEN HOUR ZINC OXIDE In The Pynk LLC 13bb8426-27cd-fbc9-e063-6294a90a8bf8 2025-11-07 Warnings Exact identifier application number: M020 ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 DEW YOU ZINC OXIDE In The Pynk LLC 1365c6d8-64cb-3cb3-e063-6394a90a9d64 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 10w ZINC OXIDE e.l.f. Cosmetics, Inc c8a935e6-f7ac-4e3a-e053-2a95a90a877a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 11w ZINC OXIDE e.l.f. Cosmetics, Inc c8a94fb4-8752-587c-e053-2995a90a1e9a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 13w ZINC OXIDE e.l.f. Cosmetics, Inc c8a9bf6c-80cd-5884-e053-2a95a90a4a66 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 12w ZINC OXIDE e.l.f. Cosmetics, Inc c8a99278-21e0-c517-e053-2a95a90ade37 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 1C ZINC OXIDE e.l.f. Cosmetics, Inc c8a82c8b-e308-15e9-e053-2995a90afa2a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 14w ZINC OXIDE e.l.f. Cosmetics, Inc c8aa4629-1573-48a7-e053-2995a90aa86c 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 2w ZINC OXIDE e.l.f. Cosmetics, Inc. c8a82f54-839d-1de0-e053-2a95a90a2a97 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 4W ZINC OXIDE e.l.f. Cosmetics, Inc c8a83921-3181-396e-e053-2a95a90a02ee 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 3N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce3e-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 5N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce42-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 6w ZINC OXIDE e.l.f. Cosmetics, Inc c8a8ef6f-4426-a981-e053-2a95a90a9451 2025-11-07 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