Home NDC 85319-201 SHADED
Product NDC 85319-201
11-digit product format 853190201
Labeler code 85319
Product ID 85319-201_459bde25-f541-9aa4-e063-6394a90a6cb1
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Potency No. 710 LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-08-14
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 80; 38 mg/g; 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 SHADED
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 80 mg/g ZINC OXIDE 38 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z 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 85319-201-85 SHADED 85 g in 1 BOTTLE, PUMP CREAM 85 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85319-201 SHADED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [POTENCY NO. 710 LLC] 1 Current NDC, 1 package rows 20250326_31177bbd-68b0-8b24-e063-6294a90aa8d8.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 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 85319-201-85 85319020185 85 g in 1 BOTTLE, PUMP (85319-201-85) 85 g 2020-08-14 No No Current