Home NDC 85414-201 Tinted Mineral Sunscreen
Product NDC 85414-201
11-digit product format 854140201
Labeler code 85414
Product ID 85414-201_459b7e47-36a8-ad1a-e063-6294a90aa550
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Hirschman, Kristina
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-08
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 Tinted Mineral Sunscreen
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 85414-201-85 Tinted Mineral Sunscreen 85 g in 1 BOTTLE, PLASTIC CREAM 85 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85414-201 TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HIRSCHMAN, KRISTINA] 1 Current NDC, 1 package rows 20250523_35ba578f-a842-7eec-e063-6394a90a1165.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 85414-201-85 85414020185 85 g in 1 BOTTLE, PLASTIC (85414-201-85) 85 g 2023-11-08 No No Current