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 36 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join White Mint SPF 15 Broad Spectrum Lip Balm WHITE MINT SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc 50ff8c38-94f1-f589-e063-6294a90a5ba8 2026-05-04 Warnings Exact identifier application number: M020 Surface Sun SPF 50 Mineral ZINC OXIDE Surface Products Corp cabaf7e1-b940-4d6e-b21b-d99c3a4047a7 2026-05-04 Warnings Exact identifier application number: M020 SPF 50 Dry Touch Continuous No fragrance HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00% Surface Products Corp 503d6b48-3516-4264-9fe8-71a9939669fe 2026-05-04 Warnings Exact identifier application number: M020 Surface SPF 50 3oz Tinted mineral sunscreen with Water Resistance ZINC OXIDE Surface Products Corp 02b770cf-7351-444b-b2c8-ad112e9bea3e 2026-05-04 Warnings Exact identifier application number: M020 SPF 30 Dry Touch Continuous No fragrance HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00% Surface Products Corp d13c9e6e-a5da-4691-8792-9d6025e166d7 2026-05-04 Warnings Exact identifier application number: M020 LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM TITANIUM DIOXIDE, ZINC OXIDE Drmtlgy, LLC 0206c676-c24d-470e-adb2-7cb3173f3727 2026-05-04 Warnings Exact identifier application number: M020 LUMINOUS EYE CORRECTOR SPF 41 - TAN TITANIUM DIOXIDE, ZINC OXIDE Drmtlgy, LLC 5c5aad09-9f93-4634-8db1-c67570b38b2b 2026-05-04 Warnings Exact identifier application number: M020 OBGE PORE-ZERO Oil CONTROL SUN Stick HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Adapt Inc. 67209e46-1b7a-42df-b31f-fcb3cefbd7e1 2026-05-03 Warnings Exact identifier application number: M020 Equate OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE WALMART INC 2617e5bc-27a2-f187-e063-6394a90a6980 2026-05-03 Warnings Exact identifier application number: M020 THANK YOU FARMER Sun Project Rice Tinted Mineral Sun Cream ZINC OXIDE THANK YOU FARMER CO., LTD 20a44597-3d44-f0ea-e063-6294a90a903d 2026-05-03 Warnings Exact identifier application number: M020 Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Grace and Fire USA Inc. 4df3e90e-98a0-edbf-e063-6394a90ae3c9 2026-05-01 Warnings Exact identifier application number: M020 Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50 AVOBENZONE, OCTINOXATE, OCTOCRYLENE Grace and Fire USA Inc. 4df6d28b-64ce-59b3-e063-6394a90a6360 2026-05-01 Warnings Exact identifier application number: M020 EXTREME PROTECT SPF 30 OCTINOXATE, ZINC OXIDE SCIENCE OF SKINCARE LLC ecc4d304-e7e2-45b6-b9b2-2c64d3630860 2026-05-01 Warnings Exact identifier application number: M020 Blue Lizard Sport SPF 50 Sunscreen OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories 4955fa1c-789d-4f42-af75-70223310644a 2026-05-01 Warnings Exact identifier application number: M020 Blue Lizard Kids SPF 50 Sunscreen OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories ba4ae906-48c0-8384-e053-2995a90afb91 2026-05-01 Warnings Exact identifier application number: M020 Sun Shield Mineral UV Barrier Protect Broad Spectrum SPF 40 Sunscreen ZINC OXIDE Obagi Cosmeceuticals LLC 54a3f855-48de-4ae0-b1f0-e95739853065 2026-05-01 Warnings Exact identifier application number: M020 MEDICUBE PDRN HYDRATING UV SERUM HOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLE APR US INC 50a73981-985a-0a70-e063-6394a90a89cf 2026-04-30 Warnings Exact identifier application number: M020 Sky and Sol Body Sunscreen NON- NANO ZINC OXIDE Delta Ecommerce LLC 2ddaa628-0e81-c8a7-e063-6394a90a84f4 2026-04-30 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool Rosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6831832a-e52e-43ea-899f-f5d44bea5a94 2026-04-30 Warnings Exact identifier application number: M020 Carmex 10 count variety pack Lip Balm OCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUM Carma Laboratories, Inc. 9c5168d5-31ed-4ce1-b16a-5f51f7e44ed2 2026-04-30 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