Home NDC 59958-404 Chem Free SPF 30
Product NDC 59958-404
11-digit product format 599580404
Labeler code 59958
Product ID 59958-404_2b996b63-5943-0663-e063-6394a90a35f2
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Owen Biosciences, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-07-19
Substance ZINC OXIDE
Active strength 21 g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 59958-404 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59958-404 59958-404-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 Chem Free SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 21 g/100g
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 59958-404-01 Chem Free SPF 30 50 g in 1 TUBE CREAM 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59958-404 CHEM FREE SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250114_7e5930fe-eb0f-4a21-8065-8831dd5b351c.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 45 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59958-404-01 59958040401 50 g in 1 TUBE (59958-404-01) 50 g 2017-07-19 0000-00-00 No No Current