Home NDC 58466-109 78 x 36 SPF 30 Active
Product NDC 58466-109
11-digit product format 584660109
Labeler code 58466
Product ID 58466-109_1c2b73fd-1c52-4db3-982e-d937c04ceeac
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Dermazone LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-01
Substance ZINC OXIDE
Active strength .2 g/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 14 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 2025-04-01 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 58466-109-03 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 58466-109-03 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 58466-109-03 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 58466-109-03 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 58466-109-03 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 58466-109-03 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 58466-109-03 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base 78 x 36 SPF 30 Active
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE .2 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58466-109-03 78 x 36 SPF 30 Active 96 g in 1 TUBE CREAM 96 2 58466-109-03 78 x 36 SPF 30 Active 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58466-109 78 X 36 SPF 30 ACTIVE (ZINC OXIDE) CREAM [DERMAZONE SOLUTIONS, INC.] 1 Current NDC, 2 package rows 20231001_96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55.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 114 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Matte Defense Mineral Sunscreen non tinted TITANIUM DIOXIDE, ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698090a-1639-00f9-e063-6394a90a7dd1 2025-12-16 Exact identifier application number: M020 Daily Replenish mineral sunscreen ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698d309-b9bf-e197-e063-6294a90af5a1 2025-12-16 Exact identifier application number: M020 Zinc 20 mineral sunscreen face Plus body ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698f29e-5d80-94af-e063-6394a90a0489 2025-12-16 Exact identifier application number: M020 Tinted Mineral Primer SPF 40 TITANIUM DIOXIDE, ZINC OXIDE JOSEPHINA RAMIREZ 365cf2be-8862-3622-e063-6394a90ac4e3 2025-12-16 Exact identifier application number: M020 SANCTUARY Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CHAMPAGNE APOTHECARY LLC 365ca99c-c878-1f4b-e063-6394a90a1f53 2025-12-16 Exact identifier application number: M020 Tinted Mineral Defense SPF 40 ZINC OXIDE JOSEPHINA RAMIREZ 365d299a-5886-5597-e063-6394a90a336c 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILL VALLEY DERMATOLOGY, INC. 3b171a89-c757-47a1-e063-6294a90a7a64 2025-12-16 Warnings Exact identifier application number: M020 Tinted BB Cream ZINC OXIDE Eco Esthetics LLC 38f3e618-59e1-4504-e063-6394a90afa55 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE MADRE TIERRA, INC. 3f697463-d3db-7b73-e063-6394a90ac222 2025-12-16 Warnings Exact identifier application number: M020 Non-Tinted Replenishing Daily Protection ZINC OXIDE MADRE TIERRA, INC. 3f69d6f3-454b-e60a-e063-6394a90a8781 2025-12-16 Warnings Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE ISIS GONZALEZ 3f68b2ea-be23-100d-e063-6294a90a8b37 2025-12-16 Warnings Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE ISIS GONZALEZ 3f682b78-e1c9-e174-e063-6294a90a17ed 2025-12-16 Warnings Exact identifier application number: M020 Silk Screen Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin Science Institute Inc 36c3793a-ccb5-1e5f-e063-6294a90ad44f 2025-12-16 Exact identifier application number: M020 Silk Screen Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin Science Institute Inc 36c3a721-6be1-3f7f-e063-6394a90a522f 2025-12-16 Exact identifier application number: M020 True Tone Tinted TITANIUM DIOXIDE, ZINC OXIDE That Face PLLC 36c2bb0e-479d-89cd-e063-6294a90aa3d4 2025-12-16 Exact identifier application number: M020 True Tone Non Tinted ZINC OXIDE That Face PLLC 36c2f263-67cf-e8cf-e063-6394a90ad81f 2025-12-16 Exact identifier application number: M020 Tinted Daily Protection Sunscreen ZINC OXIDE Kemmi Lee Skin Science 37ef5a05-54d2-a8e4-e063-6394a90a8e48 2025-12-16 Exact identifier application number: M020 Aquaphor Lip Repair Stick and Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, Beiersdorf Inc d469bddf-90d4-7b1c-e053-2a95a90a1ed9 2025-12-16 Warnings Exact identifier application number: M020 Eucerin Daily Protection Face ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE Beiersdorf Inc 76403f03-aee9-4c0b-b331-f79b6953118c 2025-12-16 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION 36c0400b-8ad9-654b-e063-6294a90ad040 2025-12-16 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58466-109-03 58466010903 1 TUBE in 1 CARTON (58466-109-03) / 96 g in 1 TUBE 1 tube 2023-10-01 No No Current