Home NDC 70060-1901 Ultra Replenishing Sunscreen SPF 40
Product NDC 70060-1901
11-digit product format 700601901
Labeler code 70060
Product ID 70060-1901_09cca94c-caf2-1c88-e063-6294a90a90e5
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octisalate, Octocrylene, Zinc Oxyide cream
Dosage form CREAM
Route TOPICAL
Labeler CosMedical Technologies, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-09-16
Substance HOMOSALATE; OCTOCRYLENE; ZINC OXIDE; OCTISALATE
Active strength 80; 50; 80; 50 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 Ultra Replenishing Sunscreen SPF 40
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 80 mg/mL OCTOCRYLENE 50 mg/mL ZINC OXIDE 80 mg/mL OCTISALATE 50 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70060-1901-1 Ultra Replenishing Sunscreen SPF 40 50 mL in 1 BOTTLE, PLASTIC CREAM 50 5 70060-1901-2 Ultra Replenishing Sunscreen SPF 40 1.5 mL in 1 PACKET CREAM 1.5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70060-1901 ULTRA REPLENISHING SUNSCREEN SPF 40 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAM) CREAM [COSMEDICAL TECHNOLOGIES, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20231116_92ad5d7a-9adb-7d55-e053-2995a90a80e7.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 242 of 353 · 7,041 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 70060-1901-1 70060190101 50 mL in 1 BOTTLE, PLASTIC (70060-1901-1) 50 ml 2019-09-16 0000-00-00 No No Current 70060-1901-2 70060190102 1.5 mL in 1 PACKET (70060-1901-2) 1.5 ml 2019-09-16 0000-00-00 Yes No Current