Home NDC 85493-201 Tinted Mineral Sunscreen
Product NDC 85493-201
11-digit product format 854930201
Labeler code 85493
Product ID 85493-201_46042a36-5ccb-93a4-e063-6394a90a8867
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler CLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-11-11
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 Tinted Mineral Sunscreen
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 85493-201-85 Tinted Mineral Sunscreen 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 85493-201 TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [CLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC] 1 Current NDC, 1 package rows 20250524_35bdc7f4-4e47-ce35-e063-6294a90acf2d.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 85493-201-85 85493020185 85 g in 1 BOTTLE, PUMP (85493-201-85) 85 g 2020-11-11 No No Current