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 121 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Facial Mineral Fusion TITANIUM DIOXIDE, ZINC OXIDE IT INTELLIGENT TREATMENT LLC 35944621-e6fb-cd98-e063-6294a90aa641 2025-12-15 Exact identifier application number: M020 Face Love ZINC OXIDE CLARITY SKIN CARE STUDIO, INC. 35d043a7-7269-469f-e063-6294a90a1a4d 2025-12-15 Exact identifier application number: M020 Mineral Mousse TITANIUM DIOXIDE, ZINC OXIDE CLARITY SKIN CARE STUDIO, INC. 35d00778-3857-ce8f-e063-6394a90ab375 2025-12-15 Exact identifier application number: M020 Chem-Free Sunscreen Non-Tinted Formula ZINC OXIDE IT INTELLIGENT TREATMENT LLC 3594d573-c680-62c9-e063-6294a90a4229 2025-12-15 Exact identifier application number: M020 Chem Free Sunscreen Tinted Formula ZINC OXIDE IT INTELLIGENT TREATMENT LLC 35948531-37ef-1fce-e063-6294a90ae79b 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE R. Sonia Batra, MD, Inc. 35933039-8beb-9f98-e063-6394a90a60bb 2025-12-15 Exact identifier application number: M020 Simply Protected Tinted Mineral Sunscreen ZINC OXIDE Healthy Skin & Body LLC 380416b9-180a-3904-e063-6294a90a7bee 2025-12-15 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE R. Sonia Batra, MD, Inc. 3592edca-cab0-6c44-e063-6294a90a1727 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Healthy Skin & Body LLC 38046e71-f171-7e96-e063-6294a90a1f0b 2025-12-15 Exact identifier application number: M020 Barrier Plus Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Healthy Skin & Body LLC 38038beb-d0f0-ced2-e063-6294a90ac423 2025-12-15 Exact identifier application number: M020 Extreme Protection Non Tinted ZINC OXIDE BIOHEALTH PLUS LLC 3764cbeb-55f5-4a9c-e063-6394a90a863d 2025-12-15 Exact identifier application number: M020 Happy Mineral Sunscreen Primer SPF TITANIUM DIOXIDE, ZINC OXIDE ACNE CLINIC LAS VEGAS BY JUSTINA 37d9c5f2-f414-6efa-e063-6294a90a927f 2025-12-15 Exact identifier application number: M020 Comfort Mineral Mousse Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BIOHEALTH PLUS LLC 3765dd17-ffbd-bcf4-e063-6394a90a2c2b 2025-12-15 Exact identifier application number: M020 Prime And Protect Dewy ZINC OXIDE Kalon Skin Studio, LLC 3593cefe-a08f-eb88-e063-6394a90aaff6 2025-12-15 Exact identifier application number: M020 Glow ZINC OXIDE GODDESSLYNNEBODYANDSKIN 37247365-33ee-563d-e063-6394a90a249e 2025-12-15 Exact identifier application number: M020 Prime And Protect Matte TITANIUM DIOXIDE, ZINC OXIDE Kalon Skin Studio, LLC 35939630-1166-1c70-e063-6294a90aac6b 2025-12-15 Exact identifier application number: M020 Non-Tinted 20% Zinc Mineral Sunscreen ZINC OXIDE BELLA MEDICAL SKIN CARE 36d9d83b-7da5-a006-e063-6394a90a9d84 2025-12-15 Exact identifier application number: M020 Non-Tinted 20% Zinc Mineral Sunscreen ZINC OXIDE BELLA MEDICAL SKIN CARE 36da1a55-c076-cdd9-e063-6294a90ac97c 2025-12-15 Exact identifier application number: M020 Tinted Lip Balm TITANIUM DIOXIDE, ZINC OXIDE Goldberg, Howard S MD Inc 3598205d-2e87-9292-e063-6294a90a1f2a 2025-12-15 Exact identifier application number: M020 Tinted Daily Replenishing Protection ZINC OXIDE Goldberg, Howard S MD Inc 3597dccf-07a1-5cd9-e063-6294a90aca71 2025-12-15 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