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 257 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLE CCC Neutral Medium Light TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. 615f5e39-695d-41d4-af59-e0d3b76789bb 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Warm Deep TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE KW ABSC, INC. 6ab3e360-8104-4439-93fb-e11bc4a77558 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Neutral Medium TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. a297ff64-678c-4936-8384-022606a2f33c 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Neutral Fair TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a2 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Cool Medium Deep TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. 2e0365f9-d3c6-4404-90ac-772a829b3ade 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18- D2 NUTMEG OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29abae8f-53db-b592-e063-6294a90adabb 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 MOCHA OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29aba80c-55b7-b8d9-e063-6294a90a5cc1 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 COCOA OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29abe97b-e9b3-6e27-e063-6294a90ae3ed 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 DEEP GOLDEN OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29abdf3c-fb54-a5e3-e063-6394a90af450 2024-12-19 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM FAIR ZINC OXIDE COSMAX USA, CORPORATION 29ac756b-3df7-50c9-e063-6394a90aa479 2024-12-19 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM RICH ZINC OXIDE COSMAX USA, CORPORATION 29ac51a0-07e7-ad7b-e063-6294a90ae777 2024-12-19 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM DEEPEST ZINC OXIDE COSMAX USA, CORPORATION 29ad12e2-0a2e-7138-e063-6394a90aebaf 2024-12-19 Warnings Exact identifier application number: M020 CeraVe Developed with Dermatologists Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Face Sheer Tint Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products, Inc. f2e34230-7bfb-455f-8b33-6bff96fd9f0a 2024-12-19 Warnings Exact identifier application number: M020 Anew Platinum DayCream Broad Spectrum SPF 25 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE COSMAX USA, CORPORATION 56200212-bedc-6e1e-e063-6394a90a3666 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELL OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29868d60-b900-e0ad-e063-6294a90af87a 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM ZINC OXIDE COSMAX USA, CORPORATION 298707d4-72ed-796f-e063-6294a90aa5cd 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM LIGHT ZINC OXIDE COSMAX USA, CORPORATION 29871c02-9adf-6266-e063-6394a90a20ab 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM TAN ZINC OXIDE COSMAX USA, CORPORATION 29874029-24bf-b2ce-e063-6394a90acd4d 2024-12-18 Warnings Exact identifier application number: M020 Babo Botanicals Sheer Zinc Mineral Sunscreen SPF 30 ZINC OXIDE Babo Botanicals, Inc. 2990e4ff-5bdb-3008-e063-6294a90a9497 2024-12-18 Warnings Exact identifier application number: M020 Tinted Lip Cream SPF 15 ZINC OXIDE COSMAX USA, CORPORATION 29915354-4673-7444-e063-6294a90a0fd1 2024-12-18 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