Home NDC 85508-203 Tinted Facial Mineral Sunscreen SPF 40
Product NDC 85508-203
11-digit product format 855080203
Labeler code 85508
Product ID 85508-203_45c70020-8290-d6dd-e063-6394a90a8433
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler RSL89 LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-28
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 Facial Mineral Sunscreen SPF 40
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 85508-203-15 Tinted Facial Mineral Sunscreen SPF 40 1.5 g in 1 PACKET CREAM 1.5 2 85508-203-50 Tinted Facial Mineral Sunscreen SPF 40 53 g in 1 BOTTLE, PUMP CREAM 53 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85508-203 TINTED FACIAL MINERAL SUNSCREEN SPF 40 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [RSL89 LLC] 1 Current NDC, 1 package rows 20250519_3531d609-a0d8-cb59-e063-6394a90a4bea.zip 85508-203 TINTED FACIAL MINERAL SUNSCREEN SPF 40 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [RSL89 LLC] 1 Current NDC, 1 package rows 20250519_3532a6a2-dbb5-8111-e063-6294a90aeaeb.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 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 85508-203-15 85508020315 1.5 g in 1 PACKET (85508-203-15) 1.5 g 2023-07-06 Yes No Current 85508-203-50 85508020350 53 g in 1 BOTTLE, PUMP (85508-203-50) 53 g 2023-02-28 No No Current