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 310 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry Skin OCTINOXATE L'Oreal USA Products Inc a45fef28-5dde-48b2-b7c0-ede694f4c32b 2023-12-30 Warnings Exact identifier application number: M020 it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All Shades TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 34f0c2c9-a5bc-4b25-bfc1-336dcbb353e4 2023-12-30 Warnings Exact identifier application number: M020 Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc fb9daea3-c249-417c-ad34-3e89f3118559 2023-12-30 Warnings Exact identifier application number: M020 Kiehls Since 1851 Broad Spectrum SPF 30 Sunscreen Powerful Wrinkle Reducing AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 3f58b258-b954-41f0-93ad-f6c9fe25718d 2023-12-30 Warnings Exact identifier application number: M020 Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen Water Resistant 80 MInutes AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE L'Oreal USA Products Inc 2d2fbd8b-a90f-465a-9bf3-75cd6abdc6d3 2023-12-30 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Ultra Firming and Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc bf0e22df-4043-407f-a930-29595da1bdf6 2023-12-30 Warnings Exact identifier application number: M020 Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 50 Sunscreen Water Resistant 80 MInutes AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE L'Oreal USA Products Inc 04fd0839-5046-4633-a919-6b7b6bea4f3e 2023-12-30 Warnings Exact identifier application number: M020 Kiehls Since 1851 Dermatologist Solutions Super Fluid Daily UV Defense Broad Spectrum SPF 50 plus Sunscreen Antipollution Lightweight Formula AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE L'Oreal USA Products Inc. ed138c48-d542-4522-a23c-1b586aad1127 2023-12-30 Warnings Exact identifier application number: M020 Kiehls Since 1851 Ultra Facial Moisturizer Broad Spectrum SPF 30 Sunscreen For All Skin Types AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc d1a8c8d2-59d2-4389-9369-5f9b053a956e 2023-12-30 Warnings Exact identifier application number: M020 Lancome Paris Visionnaire Broad Spectrum SPF 20 Sunscreen Advanced Multi Correcting All Skin Types AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 43041108-6adb-4dd3-a75f-87f5d643c794 2023-12-30 Warnings Exact identifier application number: M020 Lancome Paris Bienfait MultiVital Eye Broad Spectrum SPF 30 Sunscreen AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 449a6027-4d0d-40e1-af58-3553071d6fdf 2023-12-30 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. baff2dfe-fd0b-0709-e053-2a95a90a431b 2023-12-29 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. bb013e70-f081-f8f2-e053-2995a90a1981 2023-12-29 Warnings Exact identifier application number: M020 Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skin AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 1c83726b-f8ff-48d5-bf30-bc75e3fb149d 2023-12-29 Warnings Exact identifier application number: M020 LOreal Paris True Match Lumi Healthy Luminous Makeup Broad Spectrum SPF 20 OCTINOXATE L'Oreal USA Products Inc cf39375c-de44-47de-bf15-fce4dfad8c74 2023-12-29 Warnings Exact identifier application number: M020 Loreal Paris Age Perfect Radiant Serum foundation SPF 50 HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 06a94c28-bfb7-4842-a463-459205477cd8 2023-12-29 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - PEACHES N SOL ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC e7c9c914-9972-4b55-a49d-cbc8ce075647 2023-12-29 Warnings Exact identifier application number: M020 LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25 AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 8840da10-63cb-47ea-ad46-1ae6df1639e8 2023-12-29 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - PINK SUNRISE ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC 289fb410-7884-4bc4-a25b-963de1cc3a70 2023-12-29 Warnings Exact identifier application number: M020 LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 Sunscreen OCTINOXATE L'Oreal USA Products Inc 82a6fbba-f0d4-475f-9ba7-615118eed70d 2023-12-29 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