Home NDC 61354-084-01 Cream
Product NDC 61354-084
Requested package NDC 61354-084-01
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 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 78 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior e4dbfd77-0eec-4d1a-94d6-4daca096d8c7 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 72569958-cd7d-4d52-add4-2b13706e1b1e 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 0f5aa600-4168-419b-95d7-569764b5f0b9 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior e5ab0cd9-ae7f-4558-b5ab-e0b582677224 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b9fa3bb9-12ec-40d8-b433-a96d9d00cc90 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f7b2e348-2c7f-4ff5-8ab0-a3475c9d1f26 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 69924eb8-a8ca-4ea0-b087-c865a6a1313f 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5cafac21-fb2d-4d63-a7fe-01bf53b941e8 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior bfc27e8d-e59b-46f7-aec9-2a96a00a7c1c 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 8fd56c86-ef37-4f31-87d1-6283a19c8424 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 91b62ba7-2deb-47e6-b9af-25bb459b4d75 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6eec7554-38ed-48d4-916d-ab3660fbf703 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 939e6d5c-3dd7-4b01-af18-697dc4ba2d99 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 7149784b-3548-4643-abf6-58fde237bb98 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 061181d8-5387-4541-a7d7-426cba5997a0 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f6ad554a-4795-4149-b066-c53a0989470e 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 58efeaaf-d3c6-44e9-b60f-8f22f5bb1d33 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f6b4a90b-5905-4f62-9e35-f2b1dda8dddd 2026-01-16 Warnings Exact identifier application number: M020 Poolside Frostbite Sunscreen Watermelon SPF 15 Scented Lip Gloss HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE I World LLC 42c8fd50-73c6-480b-9d7e-31157e586929 2026-01-16 Warnings Exact identifier application number: M020 HYDRA VIZOR HUEZ TINTED MOISTURIZER BROAD SPECTRUM SPF 30 ZINC OXIDE KENDO HOLDINGS INC. 18fb7472-746f-339a-e063-6294a90a267d 2026-01-16 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