Home NDC 85403-211 Comfort Mineral Mousse Sunscreen
Product NDC 85403-211
11-digit product format 854030211
Labeler code 85403
Product ID 85403-211_4603cf13-1933-9811-e063-6294a90a613a
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler BIOHEALTH PLUS LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-21
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 100; 30 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 Comfort Mineral Mousse Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 100 mg/g TITANIUM DIOXIDE 30 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 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 85403-211-04 Comfort Mineral Mousse Sunscreen 100 g in 1 CYLINDER AEROSOL, FOAM 100 2
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 85403-211-04 85403021104 100 g in 1 CYLINDER (85403-211-04) 100 g 2023-03-21 No No Current