Home NDC 49527-081 CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER
Product NDC 49527-081
11-digit product format 495270081
Labeler code 49527
Product ID 49527-081_0828eba6-8d0e-9a5a-e063-6394a90a2fca
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE
Dosage form LOTION
Route TOPICAL
Labeler CLINIQUE LABORATORIES LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-07-21
Substance AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength 30; 74; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL
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 CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL OCTINOXATE 74 mg/mL OCTISALATE 50 mg/mL OXYBENZONE 20 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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49527-081-01 CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER 1 in 1 CARTON LOTION 1 5 49527-081-01 CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER 100 mL in 1 TUBE LOTION 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49527-081 CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [CLINIQUE LABORATORIES LLC] 5 Current NDC, Legacy NDC, 2 package rows 20231021_2e9463df-1c71-465f-9820-6cedefe07ad7.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 Marketing end Sample Exclude flag Status 49527-081-01 49527008101 1 TUBE in 1 CARTON (49527-081-01) / 100 mL in 1 TUBE 1 tube 2021-07-21 0000-00-00 No No Current