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 330 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2N ENSULIZOLE, OCTISALATE Parfums Christian Dior c790b9e4-6925-4796-9945-1c5484116a23 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2W ENSULIZOLE, OCTISALATE Parfums Christian Dior f551db8d-7447-41b9-9249-5ee8f76be98a 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010 OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDE Parfums Christian Dior 775f4009-9fc2-475b-a141-b4b5e5542180 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030 OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDE Parfums Christian Dior 189f8767-f463-4c83-8a38-975ce8672b2a 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1,5N ENSULIZOLE, OCTISALATE Parfums Christian Dior d9c6e0e0-f88e-48ba-94db-0cb198f8dbbe 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 3N ENSULIZOLE, OCTISALATE Parfums Christian Dior a1e5e9cf-3f59-4e1d-98d6-f17ed1ad8e51 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2CR ENSULIZOLE, OCTISALATE Parfums Christian Dior 2345d277-3d46-4dfc-9c5d-db7887165ea6 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 5N ENSULIZOLE, OCTISALATE Parfums Christian Dior cfd207af-d650-4333-a79a-c8f4878e8f9a 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 7N ENSULIZOLE, OCTISALATE Parfums Christian Dior 5f5e61e3-ea93-401b-b55c-1eb0a711e738 2023-11-03 Warnings Exact identifier application number: M020 FOREVER SKIN VEIL Extreme Wear and Moisturizing Primer Correction, Protection, Illumination With Sunscreen Floral Extract-Enriched Broad Spectrum SPF20 OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c59b4ece-0534-4072-afe8-2142a43c6bb2 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 4N ENSULIZOLE, OCTISALATE Parfums Christian Dior cfeb19b9-6597-4bd7-a635-d4024e291c5c 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 6N ENSULIZOLE, OCTISALATE Parfums Christian Dior c044849f-94ab-4d91-aac5-e3e9631bc8b1 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Parfums Christian Dior cdc2a156-5ccd-4d40-98af-c529f0911a9e 2023-11-03 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h Wear Radiant Perfection Skin Caring Foundation With Sunscreen BROAD SPECTRUM SPF 35 Lasting Hydration 2WP OCTINOXATE, TITANIUM DIOXIDE PARFUMS CHRISTIAN DIOR 6ee0284e-739d-4aad-9352-9ea9c106efa4 2023-11-03 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Coconut Lip Balm ZINC OXIDE Raining Rose, Inc. 2a03abc4-824b-438d-acc5-469853057679 2023-11-03 Warnings Exact identifier application number: M020 BEAUTY BEFORE AGE AHAVA UPLIFT DAY broad spectrum SPF 20 HOMOSALATE, OCTISALATE, AND AVOBENZONE AHAVA Dead Sea Laboratories Ltd bf872bbe-a2d1-4188-b331-e62e339b13e7 2023-11-03 Warnings Exact identifier application number: M020 All Good Broad Spectrum SPF 15 Spearmint Lip Balm BROAD SPECTRUM SPF 15 SPEARMINT LIP BALM Raining Rose, Inc. 77370d4e-6888-4cb7-b6b9-1011a71dbf7a 2023-11-03 Warnings Exact identifier application number: M020 365 Everyday Value SPORT LOTION MINERAL SUNSCREEN SPF 30 Whole Foods Market, Inc. 8f15b988-c009-4ca7-bb46-c0fb0aa62643 2023-11-03 Warnings Exact identifier application number: M020 365 Everyday Value SPORT LOTION MINERAL SUNSCREEN SPF 30 Whole Foods Market, Inc. 706ed90d-fd98-44bf-99b8-f8c12eec6857 2023-11-03 Warnings Exact identifier application number: M020 THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20 OCTINOXATE AND TITANIUM DIOXIDE MAX HUBER RESEARCH LAB INC 97787725-9175-46a7-8e3a-af5d06e21d7f 2023-10-30 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