Home NDC 85585-203 Tinted Mineral Sunscreen
Product NDC 85585-203
11-digit product format 855850203
Labeler code 85585
Product ID 85585-203_46161253-7b9f-afb1-e063-6394a90a64d5
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-30
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 85585-203-15 Tinted Mineral Sunscreen 1.5 g in 1 PACKET CREAM 1.5 2 85585-203-50 Tinted Mineral Sunscreen 53 g in 1 BOTTLE, PUMP CREAM 53 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 27 of 361 · 7,213 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85585-203-15 85585020315 1.5 g in 1 PACKET (85585-203-15) 1.5 g 2021-03-23 Yes No Current 85585-203-50 85585020350 53 g in 1 BOTTLE, PUMP (85585-203-50) 53 g 2025-05-30 No No Current