Home NDC 49527-228 UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS
Product NDC 49527-228
11-digit product format 495270228
Labeler code 49527
Product ID 49527-228_4e0bd321-ae7f-73e5-e063-6394a90a6620
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE and ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler CLINIQUE LABORATORIES LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-27
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 207; 38 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS
Brand name suffix DARK SHADE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 207 mg/mL TITANIUM DIOXIDE 38 mg/mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49527-228-01 UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTSDARK SHADE 1 in 1 CARTON CREAM 1 1 49527-228-01 UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTSDARK SHADE 40 mL in 1 TUBE CREAM 40 1
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 49527-228-01 49527022801 1 TUBE in 1 CARTON (49527-228-01) / 40 mL in 1 TUBE 1 tube 2026-03-27 No No Current