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 227 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BRUSH ON BLOCK SPF 50 KIDS MINERAL ZINC OXIDE SPF Ventures, LLC 2f17b5fe-44da-964b-e063-6394a90ae699 2025-02-26 Warnings Exact identifier application number: M020 Sun Defense Minerals (Tan) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2efb73a6-601d-61a4-e063-6294a90af825 2025-02-25 Warnings Exact identifier application number: M020 Rida Hair Research Institute AVOBENZONE,OCTISALATE,OCTOCRYLENE Rida LLC ece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca 2025-02-25 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 70 Peach Blossom AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed217698-f552-677e-e053-2995a90acb0a 2025-02-25 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 30 Tropical Coconut AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed0f8249-aba8-b67c-e053-2a95a90af7eb 2025-02-25 Warnings Exact identifier application number: M020 Hydro Essence Broad Spectrum Sunscreen SPF 40 ZINC OXIDE, OCTINOXATE Private Label Skin Care f176c1b1-f539-417f-98b5-69d99365f2f2 2025-02-25 Warnings Exact identifier application number: M020 Sun Defense Minerals (Tan) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2ee82379-6609-fd8e-e063-6294a90acf6c 2025-02-24 Warnings Exact identifier application number: M020 Vacation SPF 50 Classic AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vacation Inc. f2780cb5-063c-10d3-e053-2995a90a8576 2025-02-24 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 2ee9b3dc-91cd-1af9-e063-6394a90a78e1 2025-02-24 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 2edc79f8-aac5-15eb-e063-6394a90a9736 2025-02-23 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-C OCTINOXATE, ZINC OXIDE BEL STAR S A dc25651b-0e30-c325-e053-2995a90a809e 2025-02-21 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-C OCTINOXATE, ZINC OXIDE BEL STAR S A dc129cd6-a173-d2b3-e053-2a95a90aa04e 2025-02-21 Warnings Exact identifier application number: M020 COOLA Classic Liplux Lip Balm SPF 30 Tinted AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC eec6e7c8-17fe-f34b-e053-2995a90a78a0 2025-02-20 Warnings Exact identifier application number: M020 Drops AVOBENZONE OCTISALATE OCTOCRYLENE Vacation Inc. 1319d6ea-a580-79c5-e063-6394a90a4dca 2025-02-20 Warnings Exact identifier application number: M020 Vacation SPF 50 Super Spritz Face Mist AVOBENZONE, OCTISALATE, OCTOCRYLENE Vacation Inc. f67fbe98-93ce-2882-e053-2a95a90ab713 2025-02-20 Warnings Exact identifier application number: M020 REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 10edc0c1-9359-4c7a-a56e-bad06fea0056 2025-02-20 Warnings Exact identifier application number: M020 Mineral SPF 30 Brush-On Sun Defense ZINC OXIDE Mineral Fusion 29733dba-8824-461e-be44-335d6fe50d60 2025-02-19 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 20cd4d96-2046-3a50-e063-6394a90a1219 2025-02-18 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 30 Pina Colada AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC edc59de7-c817-1a59-e053-2995a90a3408 2025-02-17 Warnings Exact identifier application number: M020 Liplux SPF 30 Lip Balm CLASSIC COOLA LLC b47b5f3a-43f3-ae7a-e053-2995a90ae16d 2025-02-17 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