Home NDC 83628-203 Silk Screen
Product NDC 83628-203
11-digit product format 836280203
Labeler code 83628
Product ID 83628-203_3c457455-b9b2-546b-e063-6294a90a41f6
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Skin Apeel, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-02
Substance TITANIUM DIOXIDE
Active strength 80 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Silk Screen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 80 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83628-203-50 Silk Screen 53 g in 1 BOTTLE, PUMP CREAM 53 1
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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83628-203-50 83628020350 53 g in 1 BOTTLE, PUMP (83628-203-50) 53 g 2025-01-02 No No Current