Home NDC 49527-083-01 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30
Product NDC 49527-083
Requested package NDC 49527-083-01
11-digit product format 495270083
Labeler code 49527
Product ID 49527-083_0a35474f-c644-433e-e063-6294a90a3a75
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE
Dosage form CREAM
Route TOPICAL
Labeler CLINIQUE LABORATORIES LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-12
Substance AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE
Active strength 30; 70; 35; 45 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 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 70 mg/mL OCTINOXATE 35 mg/mL OCTISALATE 45 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49527-083-01 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 1 in 1 CARTON CREAM 1 2 49527-083-01 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 50 mL in 1 JAR CREAM 50 2 49527-083-02 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 75 mL in 1 JAR CREAM 75 2 49527-083-02 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 1 in 1 CARTON CREAM 1 2 49527-083-03 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 1 in 1 CARTON CREAM 1 2 49527-083-03 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 15 mL in 1 JAR CREAM 15 2 49527-083-04 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 1 in 1 CARTON CREAM 1 2 49527-083-04 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 5 mL in 1 JAR CREAM 5 2 49527-083-05 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 30 mL in 1 JAR CREAM 30 2 49527-083-05 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49527-083 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 (AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC] 2 Current NDC, 10 package rows 20231116_fb841fd7-0c78-01a1-e053-6394a90a4382.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 49527-083-01 49527008301 1 JAR in 1 CARTON (49527-083-01) / 50 mL in 1 JAR 1 jar 2023-05-12 No No Current