Home NDC 85296-203 Mineral Sunscreen SPF 40 Tinted
Product NDC 85296-203
11-digit product format 852960203
Labeler code 85296
Product ID 85296-203_45775092-9f95-3865-e063-6294a90a7579
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Skin Restoration Aesthetics
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-18
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 38; 80 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 Mineral Sunscreen SPF 40 Tinted
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 38 mg/g TITANIUM DIOXIDE 80 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 85296-203-50 Mineral Sunscreen SPF 40 Tinted 50 g in 1 BOTTLE, PUMP CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85296-203 MINERAL SUNSCREEN SPF 40 TINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN RESTORATION AESTHETICS] 1 Current NDC, 1 package rows 20250309_2fc55e8c-41d6-15cc-e063-6394a90ac543.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 85296-203-50 85296020350 50 g in 1 BOTTLE, PUMP (85296-203-50) 50 g 2024-04-18 No No Current