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 116 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE SAN JOSE MEDICAL SPA 37ef19e5-1775-a8d5-e063-6394a90acaef 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE, TITANIUM DIOXIDE BABYFACE LLC 36d69eb5-59b4-14a0-e063-6394a90a0a49 2025-12-16 Exact identifier application number: M020 Non Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BABYFACE LLC 36d6141c-6967-d779-e063-6294a90af0a7 2025-12-16 Exact identifier application number: M020 Replenishing Daily Sunscreen ZINC OXIDE BABYFACE LLC 36d773d7-349d-68c1-e063-6394a90aff1e 2025-12-16 Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Light ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d44158a-44b3-5a3d-e063-6294a90a1f16 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Light-Medium ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d53071f-0275-d00c-e063-6294a90afcca 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Medium ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d550967-25af-3e7a-e063-6394a90a2c79 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Medium-Deep ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d57790c-22cf-08aa-e063-6394a90aeac0 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Deep ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d5813e8-a219-db90-e063-6294a90a6ca7 2025-12-16 Warnings Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c043e0-fd6c-5f7a-e063-6294a90a8899 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c0c1ca-80a8-9d37-e063-6294a90a824f 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c0f5df-6bfb-3c0d-e063-6294a90a2e5f 2025-12-16 Exact identifier application number: M020 Daily Protect Mineral Sunscreen ZINC OXIDE SARAH'S 4617beb7-381e-8994-e063-6394a90a14b5 2025-12-16 Warnings Exact identifier application number: M020 SHISEIDO URBAN ENVIRONMENT ENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDE Shiseido Americas Corporation 8db9f5e0-a8d6-4872-b4c6-cb92c43d25c2 2025-12-16 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE N AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Shiseido Americas Corporation 18ed9b7f-bdbe-45d7-a38c-6d065080ae99 2025-12-16 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE FOR BODY N ENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Shiseido Americas Corporation a2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c 2025-12-16 Warnings Exact identifier application number: M020 b.tan Beach Please SPF 7 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Marque of Brands Americas, LLC bdc07d83-a34f-5262-e053-2995a90acfc3 2025-12-16 Warnings Exact identifier application number: M020 Daily Protect Tinted Mineral Sunscreen ZINC OXIDE SARAH'S 461910bd-1f74-f99e-e063-6394a90ae30e 2025-12-16 Warnings Exact identifier application number: M020 Daily Protect Tinted Mineral Sunscreen ZINC OXIDE SARAH'S 4619b08f-3e63-25aa-e063-6294a90a78d7 2025-12-16 Warnings Exact identifier application number: M020 meg ALL DAY SOOTHE SUN SHIELD BROAD SPECTRUM SPF48 Meg Cosmetics Inc 4526bacf-6451-b297-e063-6294a90af71a 2025-12-16 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