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 292 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bitchstix Very Raspberry SPF 30 Sunscreen Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Bitchstix, LLC 1d77e9c3-cffe-0bb6-e063-6294a90aacd1 2024-07-17 Warnings Exact identifier application number: M020 Bitchstix The Original SPF 30 Sunscreen Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Bitchistix, LLC 1d78148a-586c-2f7d-e063-6294a90a4691 2024-07-17 Warnings Exact identifier application number: M020 Derma E Sun Defense Face SPF 30 ZINC OXIDE TITANIUM DIOXIDE derma e d90b8f81-de7a-4022-800a-90f063e94180 2024-07-17 Warnings Exact identifier application number: M020 PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 1d611494-648b-6e5f-e063-6294a90a4500 2024-07-16 Warnings Exact identifier application number: M020 CVS Beauty 360 7-in-1 Complete Daily Moisturizer Anti-Aging Formula with Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CVS Pharmacy fa412c9d-2a8b-bf71-e053-6394a90a8a63 2024-07-16 Warnings Exact identifier application number: M020 CVS Health SPF 50 Clear AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE CVS PHARMACY f42402ff-0d70-9231-e053-2995a90aa46d 2024-07-16 Warnings Exact identifier application number: M020 CVS Health Sunburn Relief Cooling LIDOCAINE HYDROCHLORIDE CVS PHARMACY 1d6402ea-4201-27f9-e063-6294a90a43f5 2024-07-16 Warnings Exact identifier application number: M020 NYX Professional Makeup Blurscreen Primer Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 6ca01ccb-07f8-4d2c-84bb-6b251e73dad2 2024-07-16 Warnings Exact identifier application number: M020 SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc 8df98d97-a5d2-4d52-8bd2-130a13501d60 2024-07-16 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 1d4cab02-8897-6449-e063-6294a90ad72e 2024-07-15 Warnings Exact identifier application number: M020 the beach people SPF 50 ZINC OXIDE The Beach People United LLC 2e5176e2-e2f4-4b08-8528-cb1ee3c16659 2024-07-15 Warnings Exact identifier application number: M020 Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE Cosmetique Active Production 23235897-c1fc-423f-99a2-e2ad282ee744 2024-07-14 Warnings Exact identifier application number: M020 LOreal Paris Bright Reveal Broad Spectrum SPF 50 Daily UV Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 96d72471-de95-4668-8903-aed6187633a9 2024-07-14 Warnings Exact identifier application number: M020 Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60 TITANIUM DIOXIDE Cosmetique Active Production a3b5dfe5-c726-4f9c-8e4d-0e9808480d4b 2024-07-14 Warnings Exact identifier application number: M020 Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60 TITANIUM DIOXIDE LOreal USA Products Inc 2e85cf6e-a2a7-4871-bdb6-1d72088c3031 2024-07-14 Warnings Exact identifier application number: M020 Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc 664c67cc-7d63-45d7-abdd-157c041b0d3f 2024-07-14 Warnings Exact identifier application number: M020 SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE L'Oreal USA Products Inc 817c882d-72f3-4ee7-8da2-a4a32f9d167f 2024-07-14 Warnings Exact identifier application number: M020 Sun Wrangler Daily Mineral Sunscreen SPF 45 ZINC OXIDE Sun Wrangler 1d0e94f1-2996-c058-e063-6294a90a343b 2024-07-12 Warnings Exact identifier application number: M020 Derma E Sun Defense SPF 30 ZINC OXIDE AND TITANIUM DIOXIDE derma e 395b73a4-dae7-49da-9dab-ab622117c8c0 2024-07-12 Warnings Exact identifier application number: M020 the beach people SPF 30 ZINC OXIDE The Beach People United LLC 3a7cc69a-6027-4dfd-b9ef-9d4390fe630c 2024-07-12 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 61354-082-01 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