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 151 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Poolside Clear Intentions Invisible Face Sunscreen SPF 30 HOMOSALATE, OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE Longway Technology(Guangzhou)Co.,Ltd. 451b902d-892d-15f1-e063-6294a90a3024 2025-12-04 Warnings Exact identifier application number: M020 Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Vanilla Icing HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Longway Technology(Guangzhou)Co.,Ltd. 451ba227-7973-1378-e063-6294a90ae893 2025-12-04 Warnings Exact identifier application number: M020 Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Pink Ice HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Longway Technology(Guangzhou)Co.,Ltd. 451ba704-6fbd-d5a0-e063-6394a90a2fbc 2025-12-04 Warnings Exact identifier application number: M020 Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Tropic Twist HOMOSALATE,OCTOCRYLENE, OCTISALATE, AVOBENZONE Longway Technology(Guangzhou)Co.,Ltd. 451bb62e-b603-7663-e063-6294a90a46db 2025-12-04 Warnings Exact identifier application number: M020 Prequel Lip Visor SPF 30 ROSEDUST LIP 30 CLEAR The Center Brands, LLC 33d5e1ad-ba7a-25f8-e063-6294a90aa38e 2025-12-04 Warnings Exact identifier application number: M020 Resting Beach Face SPF30 Anti-Pollution Sunscreen Serum BUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENE Everyday Group Limted 54f8aca8-fbbc-498a-aaf8-aee716511dde 2025-12-04 Warnings Exact identifier application number: M020 Oh My Bod SPF50 Antioxidant Infused Dry Touch Sunscreen BUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE Everyday Group Limted 48e70326-ecf7-44c9-a4cc-2044bd6a6415 2025-12-04 Warnings Exact identifier application number: M020 LIGHTSAVE TRIPLESOME SERUM TINTED ZINC OXIDE Reve Skincare LLC 35f5652f-3e6b-71c9-e063-6294a90a9e86 2025-12-04 Warnings Exact identifier application number: M020 LIGHTSAVE TRIPLESOME SERUM IVORTY ZINC OXIDE Reve Skincare LLC 35f4dd1b-c3d9-8408-e063-6394a90a7914 2025-12-04 Warnings Exact identifier application number: M020 Activated Mineral Sunscreen Tinted ACTIVATED MINERAL SUNSCREEN TINTED Reve Skincare LLC 312a32a7-d253-f10c-e063-6294a90a803a 2025-12-04 Warnings Exact identifier application number: M020 Everyday Humans Sunscreen Lip Balm Broad Spectrum SPF30 LIP BALM SPF30 Everyday Group Limted 2d42034a-4ada-57cf-e063-6394a90a0b5f 2025-12-04 Warnings Exact identifier application number: M020 Ciele SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen SUNSCREEN 30 MINERAL LE COSMETICS INC 3bb54b93-0ab2-2ecc-e063-6394a90acac3 2025-12-04 Warnings Exact identifier application number: M020 Good Times SPF 50 Sunscreen HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE EVERYDAY GROUP LIMITED f40c6c4a-47a2-5dfe-e053-2995a90a3df3 2025-12-04 Warnings Exact identifier application number: M020 Sheer Guard Natural Mineral Sunscreen ZINC OXIDE EVERYDAY GROUP LIMITED 3257719d-dcc6-7ac5-e063-6294a90aafcd 2025-12-04 Warnings Exact identifier application number: M020 Sun Glazed SPF 30 Sunscreen Glow Oil AVOBENZONE, HOMOSALATE, OCTOCRYLENE EVERYDAY GROUP LIMITED dba8075b-be36-4787-b23d-942d0e792aa8 2025-12-04 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Deep ZINC OXIDE Crunchi, LLC. 0dc478e0-9555-4ce6-b448-7d58e3a6bae0 2025-12-04 Warnings Exact identifier application number: M020 Solbar Shield SPF40 SOLBAR SHIELD SPF40 Person and Covey bd3a9a94-fc87-4127-abf9-29e56ac9ce5d 2025-12-04 Warnings Exact identifier application number: M020 Solbar Thirty SPF 30 SOLBAR THIRTY SPF30 Person and Covey ab9ac056-61d9-43d5-a3db-2d487897cc69 2025-12-04 Warnings Exact identifier application number: M020 Solbar Fifty SPF50 SOLBAR FIFTY SPF50 Person and Covey 41fd3844-181c-4cb2-8379-f313104351ef 2025-12-04 Warnings Exact identifier application number: M020 Solbar Avo SPF35 SOLBAR AVO SPF35 Person and Covey bfe1e828-76d4-4db3-a8ba-b54b31baacad 2025-12-04 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