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 212 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences 6ce602bb-c1f4-43c1-ae61-0f05d7952db3 2025-06-05 Warnings Exact identifier application number: M020 Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences b8f08778-7e5e-4341-9a24-1ce57c6525c7 2025-06-05 Warnings Exact identifier application number: M020 Quick Dry Body Broad Spectrum SPF40 Sunscreen UVA-UVB Sunscreen with SolSci-X AVOBENZONE, OCTISALATE, AND OCTOCRYLENE MDSolarSciences 812caa99-1e1e-4ab8-9f9a-fb3384c684dd 2025-06-05 Warnings Exact identifier application number: M020 MD Daily Perfecting Moisturizer SPF 30. SPF 30 Broad Spectrum Sunscreen UVA-UVB AVOBENZONE, OCTOCRYLENE, AND OCTISALATE MDSolarSciences ba918886-d277-487a-be3b-bbe3e24343ad 2025-06-05 Warnings Exact identifier application number: M020 Gleam plus Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow Tint AVOBENZONE, OCTISALATE, AND OCTOCRYLENE MDSolarSciences 3e392af6-1401-4a2f-9ba4-e43f0fd0fca1 2025-06-05 Warnings Exact identifier application number: M020 Tint plus Tone SPF 50. SPF 50 Broad Spectrum Sunscreen Sheer Tinted Moisturizer AVOBENZONE, OCTISALATE, AND OCTOCRYLENE MDSolarSciences 51bd8962-e85a-4964-9337-2ded6b7d8ac8 2025-06-05 Warnings Exact identifier application number: M020 Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB Sunscreen AVOBENZONE, OCTISALATE, AND HOMOSALATE MDSolarSciences 0f23441c-2399-4a72-9f0a-420d25db78af 2025-06-05 Warnings Exact identifier application number: M020 Vacation Classic Whip SPF 30 Broad Spectrum SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Vacation Inc. 36da165b-bc68-24ff-e063-6294a90a304f 2025-06-05 Warnings Exact identifier application number: M020 Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Nemah, Inc. 36da2d94-fa90-b145-e063-6394a90a5854 2025-06-05 Warnings Exact identifier application number: M020 Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB Suncreen TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences 4c7f0257-fa12-40d6-9516-824b0e3a182c 2025-06-05 Warnings Exact identifier application number: M020 Mineral KidCreme SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences 9ec56c68-6fea-444b-aeed-0b5d60c42e75 2025-06-05 Warnings Exact identifier application number: M020 Kidspray Broad Spectrum Sunscreen SPF 40 AVOBENZONE, OCTISALATE, AND OCTOCRYLENE MDSolarSciences 36df811b-35d2-261d-e063-6394a90aa91e 2025-06-05 Warnings Exact identifier application number: M020 5-IN-1 TINTED FACE SUNSCREEN - FAIR ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity c0892856-cd12-4c1f-8420-866dbd0f8907 2025-06-04 Warnings Exact identifier application number: M020 Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC fbf8be03-93e2-4d7e-e053-6294a90a4fd5 2025-06-04 Warnings Exact identifier application number: M020 EltaMD UV Clear SPF46 ZINC OXIDE AND OCTINOXATE SUNSCREEN CP Skin Health Group, Inc. 60438ec5-0b1f-45fd-8ce4-debfdbdc6721 2025-06-04 Warnings Exact identifier application number: M020 LikePro Skincare Sport Day UV Face Sunscreen SPF 50 OCTOCRYLENE, ZINC OXIDE LIKE PRO OPTIMAL SKINCARE LLC b00d0efe-bf22-43a6-ba24-3d5b6ee9c5e1 2025-06-03 Warnings Exact identifier application number: M020 LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50 ZINC OXIDE LIKE PRO OPTIMAL SKINCARE LLC 2ea86aa8-2f28-40bb-9318-fec188f66010 2025-06-03 Warnings Exact identifier application number: M020 LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50 ZINC OXIDE LIKE PRO OPTIMAL SKINCARE LLC b59a3b67-0e44-426d-9379-0ca31628937a 2025-06-03 Warnings Exact identifier application number: M020 EthoSun EthoSport Stick Broad Spectrum SPF 40 ZINC OXIDE EthoSun, Inc 35372859-8f40-5eb0-e063-6294a90a6a00 2025-06-03 Warnings Exact identifier application number: M020 EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45 ZINC OXIDE EthoSun, Inc d7d2bca6-5000-4cb9-b004-b1ae286f6035 2025-06-03 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