Home NDC 49527-073 PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50
Product NDC 49527-073
11-digit product format 495270073
Labeler code 49527
Product ID 49527-073_079bb7e2-552c-cf0e-e063-6394a90a74c8
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE and ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler CLINIQUE LABORATORIES LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-01-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 63; 40 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 PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 63 mg/mL ZINC OXIDE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49527-073-01 PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50 30 mL in 1 BOTTLE LOTION 30 9 49527-073-01 PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50 1 in 1 CARTON LOTION 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49527-073 PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES LLC] 9 Current NDC, Legacy NDC, 2 package rows 20231014_68cfcbc2-a214-437e-9956-f77c90d74888.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 49527-073-01 49527007301 1 BOTTLE in 1 CARTON (49527-073-01) / 30 mL in 1 BOTTLE 1 bottle 2017-01-01 0000-00-00 No No Current