Home NDC 49527-224 UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50
Product NDC 49527-224
11-digit product format 495270224
Labeler code 49527
Product ID 49527-224_548c73b3-c691-fba2-e063-6394a90a3b5c
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE,HOMOSALATE,OCTISALATE, and OCTOCRYLENE
Dosage form CREAM
Route TOPICAL
Labeler CLINIQUE LABORATORIES LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-01
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE
Active strength 30; 45; 70; 70 mg/mL; mg/mL; 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 HYDRATING BROAD SPECTRUM SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL OCTISALATE 45 mg/mL OCTOCRYLENE 70 mg/mL HOMOSALATE 70 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 49527-224-01 UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50 40 mL in 1 TUBE CREAM 40 1 49527-224-01 UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50 1 in 1 CARTON CREAM 1 1 49527-224-02 UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50 1 in 1 CARTON CREAM 1 1 49527-224-02 UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50 5 mL in 1 TUBE CREAM 5 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 49527-224-01 49527022401 1 TUBE in 1 CARTON (49527-224-01) / 40 mL in 1 TUBE 1 tube 2026-02-01 No No Current 49527-224-02 49527022402 1 TUBE in 1 CARTON (49527-224-02) / 5 mL in 1 TUBE 1 tube 2026-02-01 No No Current 49527-224-90 49527022490 1 mL in 1 PACKET (49527-224-90) 1 ml 2026-06-18 Yes No Current