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 177 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9b0642-53ed-ec94-e063-6394a90aec3d 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d977158-8b5d-66ac-e063-6294a90a4d5c 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Kit SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0eae4b71-60be-9715-e063-6294a90af463 2025-10-20 Warnings Exact identifier application number: M020 Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen ZINC OXIDE Attitude DBA 9055-7588 Qubec Inc. 9ed70230-980c-474c-9f72-a6be0f355124 2025-10-20 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE OCTISALATE OCTOCRYLENE Edgewell Personal Care Brands LLC 419b8043-7921-ca77-e063-6394a90a99ba 2025-10-20 Warnings Exact identifier application number: M020 Illuminizing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 419c8718-6b9e-3df7-e063-6294a90a1e3b 2025-10-20 Warnings Exact identifier application number: M020 Sonni SunDay Serum ZINC OXIDE Sonni 419d4ada-fe9b-b774-e063-6394a90a3d09 2025-10-20 Warnings Exact identifier application number: M020 Lip Clear Lysine Plus Coldstick OCTINOXATE AND OXYBENZONE Quantum, Inc. 66f84e56-4a5d-4b71-8bd3-79961e7bf4fe 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Strawberry Lip Treatment OCTINOXATE AND OXYBENZONE Quantum, Inc. 2cafc97f-4cd3-4755-b394-3802c28d4ed5 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Tangerine Lip Treatment OCTINOXATE AND OXYBENZONE Quantum, Inc. 8a00194e-9e28-4257-82e5-59bc44f7897d 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Coldstick OCTINOXATE AND OXYBENZONE Quantum, Inc. c9318a8c-ba3b-4068-84df-110c9005ee1d 2025-10-20 Warnings Exact identifier application number: M020 Terez Honor Hydro Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE DEWYCREAM INC 418d054b-436f-6aa3-e063-6294a90a0f56 2025-10-19 Warnings Exact identifier application number: M020 Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50 ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Cosmocos Co., Ltd 41129799-85ed-2de2-e063-6394a90ab40c 2025-10-17 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC c5a67314-e5b2-4dd6-94e9-39c2f286c346 2025-10-17 Warnings Exact identifier application number: M020 LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREEN ZINC OXIDE Lion Pose Inc. 0310407b-fb74-aa8b-e063-6294a90ad841 2025-10-17 Warnings Exact identifier application number: M020 Thrive Daily Defense Sunscreen Balm SPF30 ZINC OXIDE Thrive Natural Care, Inc 1266bd05-1971-a7f0-e063-6394a90a089c 2025-10-17 Warnings Exact identifier application number: M020 AESOP Avail Body Sunscreen Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Emeis Cosmetics Pty Ltd 2cb40521-94ed-4e76-a4e2-de1c80155bd2 2025-10-17 Warnings Exact identifier application number: M020 AESOP Avail Facial Sunscreen Broad Spectrum SPF 25 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Emeis Cosmetics Pty Ltd bff60c2f-0cc6-493b-81a0-ed35e9746146 2025-10-17 Warnings Exact identifier application number: M020 Mineral Lip Balm Pineapple ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity 667714f6-38bc-4c94-aacc-24b46e8e59fd 2025-10-17 Warnings Exact identifier application number: M020 ELEVEN BY VENUS WILLIAMS GAME SET MATCH BODY ZINC OXIDE Eco-Chic LLC dd2fe82e-31e1-1349-e053-2995a90aa409 2025-10-16 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