Home NDC 61354-083 Cream
Product NDC 61354-083
11-digit product format 613540083
Labeler code 61354
Product ID 61354-083_e7757228-2748-0ae5-e053-2a95a90ac31c
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 61354-083-01 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 61354-083-01 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 61354-083-01 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 61354-083-01 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 61354-083-01 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 61354-083-01 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 61354-083-01 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 61354-083-01 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 61354-083-01 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 61354-083-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-083-01 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 61354-083 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e7757228-2747-0ae5-e053-2a95a90ac31c.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 211 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Age Defense for Eyes 5 in 1 ZINC OXIDE AND TITANIUM DIOXIDE Topiderm, Inc. 48d5343a-1068-4c64-a275-c180026d6947 2025-06-03 Warnings Exact identifier application number: M020 Ola Botanicals Sunscreen SPF 30 ZINC OXIDE Natural Health Partners, LLC c7a7df0b-da8f-407d-a1ee-28f75070b23c 2025-06-02 Warnings Exact identifier application number: M020 MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE Expanscience Laboratories d/b/a Mustela 95ea5442-a7ca-0c7d-e053-2a95a90ad247 2025-06-02 Warnings Exact identifier application number: M020 Bluevado Sunfix ZINC OXIDE, TITANIUM DIOXIDE Magic Blue, LLC 31f1e961-3719-f70a-e063-6394a90a481e 2025-05-31 Warnings Exact identifier application number: M020 Sunny Sailor First Mate Face Stick SPF 30 ZINC OXIDE SUNNY SAILOR LLC 8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e 2025-05-28 Warnings Exact identifier application number: M020 Dr Mercola Broad Spectrum SPF15 ZINC OXIDE Natural Health Partners, LLC 47f6b19e-ede8-0daf-e054-00144ff88e88 2025-05-28 Warnings Exact identifier application number: M020 Dr. Mercola Broad Spectrum ZINC OXIDE Natural Health Partners, LLC 47f6ec0a-1144-55dd-e054-00144ff8d46c 2025-05-28 Warnings Exact identifier application number: M020 Dr. Mercola Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE Natural Health Partners, LLC 47f6ab9e-fa73-496a-e054-00144ff8d46c 2025-05-28 Warnings Exact identifier application number: M020 Celavive Protective Day SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE USANA Health Sciences, Inc. cf00763f-6b3e-4d50-b639-9a6d6f595961 2025-05-28 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 61354-083-01 61354008301 1 TUBE in 1 CARTON (61354-083-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current