Home NDC 61354-082 Cream
Product NDC 61354-082
11-digit product format 613540082
Labeler code 61354
Product ID 61354-082_e724e10c-4f05-b03d-e053-2a95a90a754c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-26
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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 Cream 1 in 1 CARTON LOTION 1 1 61354-082-01 Cream 100 mg in 1 TUBE LOTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-082 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220827_e724e098-f5c9-262a-e053-2995a90a2a02.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 137 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ProtectME Tinted Mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE PUREFECTION LA, INC. 33dccd5d-8db1-f699-e063-6394a90a59a2 2025-12-10 Exact identifier application number: M020 Protect ME Non Tinted Mineral SPF 40 ZINC OXIDE PUREFECTION LA, INC. 34a2d716-b853-752e-e063-6394a90a52e2 2025-12-10 Exact identifier application number: M020 Tinted Mineral Moisturizing Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ABOUT FACE AESTHETICS, INC. 364728b4-e0ff-8466-e063-6394a90a0089 2025-12-10 Exact identifier application number: M020 tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin & Bare It LLC 35d42661-e511-1dfc-e063-6294a90a9ed7 2025-12-10 Exact identifier application number: M020 non-tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin & Bare It LLC 35d3ef95-621c-f193-e063-6294a90ac3ee 2025-12-10 Exact identifier application number: M020 face Plus body sunscreen tinted ZINC OXIDE Skin & Bare It LLC 35d45df5-e9bf-1a08-e063-6294a90ae04f 2025-12-10 Exact identifier application number: M020 face Plus body sunscreen non-tinted ZINC OXIDE Skin & Bare It LLC 361ef750-0f0e-bd01-e063-6294a90a0020 2025-12-10 Exact identifier application number: M020 bare skin smooth mineral tint ZINC OXIDE Skin & Bare It LLC 361f2933-73d5-a9d7-e063-6394a90abb3c 2025-12-10 Exact identifier application number: M020 Smoothing Mineral Sunscreen Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE DANIEL BEHROOZAN MD A MEDICAL CORPORATION 32721b87-aef1-d759-e063-6394a90a40d3 2025-12-10 Exact identifier application number: M020 Non-Tinted Mineral Stick TITANIUM DIOXIDE, ZINC OXIDE Shelley Bennett Skincare 326e9a14-5fb6-6a6e-e063-6294a90adece 2025-12-10 Exact identifier application number: M020 3-in-1 Daily Vanishing Tinted Sunscreen Cream ZINC OXIDE Shelley Bennett Skincare 325dae60-01cc-a120-e063-6294a90a2ef2 2025-12-10 Exact identifier application number: M020 Daily Moisturizing Glow Sunscreen Cream ZINC OXIDE Shelley Bennett Skincare 326e49b8-e21c-0df0-e063-6394a90a2ebc 2025-12-10 Exact identifier application number: M020 Daily Moisturizing Glow Sunscreen Cream ZINC OXIDE SHELLEY BENNET SKINCARE 325df1f8-1678-c07c-e063-6294a90a96fb 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bafa0b-d253-c263-e063-6394a90ad1e4 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35ba578f-a842-7eec-e063-6394a90a1165 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen Zinc Oxide ZINC OXIDE Hirschman, Kristina 35bb3b36-3886-ea8e-e063-6394a90a5257 2025-12-10 Exact identifier application number: M020 Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bc3994-1f72-2bbf-e063-6294a90ac2f1 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bccadf-6fc8-abd0-e063-6294a90aaa2e 2025-12-10 Exact identifier application number: M020 Mineral Sunscreen Zinc Oxide ZINC OXIDE Hirschman, Kristina 35bb9341-355f-4910-e063-6294a90a8c15 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bd61ff-0d66-a9b3-e063-6394a90ad940 2025-12-10 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 61354-082-01 61354008201 1 TUBE in 1 CARTON (61354-082-01) > 100 mg in 1 TUBE 1 tube 2022-08-26 0000-00-00 No No Current