Home NDC 70000-0535 Leader
Product NDC 70000-0535
11-digit product format 700000535
Labeler code 70000
Product ID 70000-0535_44fc8e0e-6b09-d5c7-e063-6394a90a8467
Type HUMAN OTC DRUG
Nonproprietary name avobenzone, homosalate, octisalate, octocrylene, oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler CARDINAL HEALTH, INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-12-03
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 30; 150; 50; 100; 60 mg/mL; 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 Leader
Brand name suffix Ultra Sheer SPF 100 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 150 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 100 mg/mL OXYBENZONE 60 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 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 70000-0535-1 LeaderUltra Sheer SPF 100 Sunscreen 89 mL in 1 TUBE LOTION 89 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0535 LEADER ULTRA SHEER SPF 100 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [CARDINAL HEALTH, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20241024_b5a467e0-a6ab-4136-8101-f22cc319de58.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 70000-0535-1 70000053501 89 mL in 1 TUBE (70000-0535-1) 89 ml 2019-12-03 0000-00-00 No No Current