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 243 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sheglam Dew and Done Skin Tint with SPF 20 Linen ZINC OXIDE EVER FAME PTE. LTD. 2abd4227-4fcf-266c-e063-6394a90a293b 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Mahogany ZINC OXIDE EVER FAME PTE. LTD. 2abd75c3-554a-d428-e063-6294a90ae77d 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Mocha ZINC OXIDE EVER FAME PTE. LTD. 2abd75c3-554f-d428-e063-6294a90ae77d 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Nude ZINC OXIDE EVER FAME PTE. LTD. 2abd8527-72a5-1564-e063-6294a90ad8d3 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Nutmeg ZINC OXIDE EVER FAME PTE. LTD. 2abdda5e-0f52-ae46-e063-6394a90ae6f5 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Porcelain ZINC OXIDE EVER FAME PTE. LTD. 2abdddbc-d891-7c4d-e063-6294a90a8162 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Russet ZINC OXIDE EVER FAME PTE. LTD. 2abe084b-7478-e923-e063-6394a90ac941 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Peach ZINC OXIDE EVER FAME PTE. LTD. 2abdca50-ffc4-8c36-e063-6394a90af766 2025-01-02 Warnings Exact identifier application number: M020 Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes) AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. c3bacceb-63a8-098c-e053-2995a90acd64 2025-01-02 Warnings Exact identifier application number: M020 Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16 ZINC OXIDE REJUVA MINERALS INC 3d83c220-1801-4193-b6a8-c777f412c173 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Saddle ZINC OXIDE EVER FAME PTE. LTD. 2abf69c5-07d7-252d-e063-6394a90a292b 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Sand ZINC OXIDE EVER FAME PTE. LTD. 2abf7869-4418-7738-e063-6394a90ae89d 2025-01-02 Warnings Exact identifier application number: M020 Good Weather Skin The One Daily Sun SPF 30 ZINC OXIDE Good Weather Inc. 2ac30544-5ece-18ed-e063-6394a90a6a0d 2025-01-02 Warnings Exact identifier application number: M020 Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plus OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE Exelencia importers Corp. 283c2780-5ad5-38f1-e063-6294a90ac336 2025-01-01 Warnings Exact identifier application number: M020 EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE Biocosmetica Exel Argentina SRL 2aabf782-65f9-e894-e063-6394a90a1ea3 2025-01-01 Warnings Exact identifier application number: M020 EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE Biocosmetica Exel Argentina SRL 2aad5b97-e64b-c678-e063-6294a90aa8c6 2025-01-01 Warnings Exact identifier application number: M020 TIBENA ALWAYS REAL SUN BLOCK UV SPF 45 AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE KONAD CO LTD 2aafbd33-710a-201e-e063-6294a90ab1bb 2025-01-01 Warnings Exact identifier application number: M020 THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-Free ENSULIZOLE, TITANIUM DIOXIDE fmg Co.Ltd d30ac897-3a30-7bba-e053-2995a90ac342 2025-01-01 Warnings Exact identifier application number: M020 THEFACESHOP Cushion CC Total Cover SPF 50 Apricot Beige ENSULIZOLE, TITANIUM DIOXIDE fmg Co.Ltd d30b0588-b0f4-39a8-e053-2a95a90abb35 2025-01-01 Warnings Exact identifier application number: M020 THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-Free ENSULIZOLE, TITANIUM DIOXIDE fmg Co.Ltd d30aeaa6-3423-401c-e053-2a95a90a8fe9 2025-01-01 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