Home NDC 85313-211 Non-Tinted Mineral Foaming Sunscreen
Product NDC 85313-211
11-digit product format 853130211
Labeler code 85313
Product ID 85313-211_459bfcc2-12be-82a9-e063-6294a90a6ca3
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Restore Skin Therapy, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-05
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 Non-Tinted Mineral Foaming 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 85313-211-04 Non-Tinted Mineral Foaming Sunscreen 113 g in 1 BOTTLE, PUMP AEROSOL, FOAM 113 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 85313-211-04 85313021104 113 g in 1 BOTTLE, PUMP (85313-211-04) 113 g 2019-08-05 No No Current