Home NDC 49527-118 REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O
Product NDC 49527-118
11-digit product format 495270118
Labeler code 49527
Product ID 49527-118_10f7ec01-541c-a15a-e063-6294a90aa9df
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler CLINIQUE LABORATORIES LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-09
Substance OCTINOXATE; TITANIUM DIOXIDE
Active strength 75; 15 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 REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 75 mg/mL TITANIUM DIOXIDE 15 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 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 49527-118-01 REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O 50 mL in 1 JAR CREAM 50 1 49527-118-01 REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49527-118 REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O (OCTINOXATE, TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES LLC] 1 Current NDC, 2 package rows 20240210_10f7ec01-541b-a15a-e063-6294a90aa9df.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 Sample Exclude flag Status 49527-118-01 49527011801 1 JAR in 1 CARTON (49527-118-01) / 50 mL in 1 JAR 1 jar 2024-02-09 No No Current