Home NDC 61354-083-01 Cream
Product NDC 61354-083
Requested package NDC 61354-083-01
11-digit product format 613540083
Labeler code 61354
Product ID 61354-083_e7757228-2748-0ae5-e053-2a95a90ac31c
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 61354-083-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-083-01 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 61354-083 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e7757228-2747-0ae5-e053-2a95a90ac31c.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 73 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 310a07bb-d32a-401f-955e-4c2860148a30 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 39ae4a97-7f96-4c95-a6de-0c779764fb02 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922fc3e-055c-e51d-e063-6294a90a00f5 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 9c7a31df-5bdd-403b-b807-1d1a801e1bb6 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922fc51-ae53-acb8-e063-6394a90a14eb 2026-01-20 Warnings Exact identifier application number: M020 Wrinkle Repair Moisturizer SPF 30 EQB AVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2% Walmart a067e968-e598-40ef-95f2-c338b5e413dd 2026-01-20 Warnings Exact identifier application number: M020 Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Welmedix LLC 48da4589-0f5a-c25b-e063-6394a90ac18b 2026-01-20 Warnings Exact identifier application number: M020 SPF 50 Mineral Sunscreen Kids ZINC OXIDE 14.69% S&C Hampton Sun LLC 0bdb7d15-dc52-4e23-9417-fe73f17f6110 2026-01-20 Warnings Exact identifier application number: M020 DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICK OCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATE DEWYTREE CO. ,LTD 48406e68-eefd-d2c2-e063-6394a90a4ad9 2026-01-20 Warnings Exact identifier application number: M020 KONEUK SUNSCREEN SPF50 KONEUK SUNSCREEN SPF50 Guangzhou Meixi Biotechnology Co., Ltd. 48dd7f6e-2a4d-2c92-e063-6294a90a4255 2026-01-20 Warnings Exact identifier application number: M020 CHUDA AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE Premier Ocher LLC 1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f 2026-01-20 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 12edec55-2414-4bbd-bc96-4599a96b96ac 2026-01-19 Warnings Exact identifier application number: M020 PROJECT REEF SPF-30 Mineral Sunscreen ZINC OXIDE Project Reef LLC a6077e6f-d987-4159-946f-3e2397247659 2026-01-19 Warnings Exact identifier application number: M020 OUTER REEF MINERAL SUNSCREEN SPF 30 TITANIUM DIOXIDE Coral Reef Park Co., Inc. 86ee2fdf-8a88-44e6-b12a-36a92360477a 2026-01-19 Warnings Exact identifier application number: M020 SABAL Mineral Sunscreen Broad Sprectrum SPF 30 ZINC OXIDE SABAL SUN LLC f917b446-4e10-4231-826e-fdac32e11186 2026-01-19 Warnings Exact identifier application number: M020 Plius Daily SPF Moisturizer SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE PLIUS, Inc 31866de9-afa0-4c11-be65-b61373551493 2026-01-19 Warnings Exact identifier application number: M020 PROTEKT SPF-50 Sheer Mineral Sunscreen ZINC OXIDE Protekt Products, Inc. 6edc0941-bb21-4797-a875-81f727694774 2026-01-19 Warnings Exact identifier application number: M020 Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21) ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20% Grace and Fire USA Inc. 48c1b93c-9c6f-95aa-e063-6294a90a0cfa 2026-01-19 Warnings Exact identifier application number: M020 ANUA INVISIBLE GLOW FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 446ac344-1078-4cd1-e063-6294a90a4bd4 2026-01-19 Warnings Exact identifier application number: M020 ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 31af7b5e-2bd6-63ee-e063-6294a90a0806 2026-01-19 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 61354-083-01 61354008301 1 TUBE in 1 CARTON (61354-083-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current