Home NDC 59450-947 Avobenzone, Homosalate, Octisalate
Product NDC 59450-947
11-digit product format 594500947
Labeler code 59450
Product ID 59450-947_4bd25620-3cc1-fefa-e063-6294a90a845b
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate
Dosage form LOTION
Route TOPICAL
Labeler The Kroger Co.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-22
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength 30; 120; 50 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 Avobenzone, Homosalate, Octisalate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 120 mg/mL OCTISALATE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup
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 59450-947-30 Avobenzone, Homosalate, Octisalate 177 mL in 1 TUBE LOTION 177 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59450-947 AVOBENZONE, HOMOSALATE, OCTISALATE LOTION [KROGER] 2 Current NDC, 1 package rows 20250426_644ec129-15c9-4ac1-8362-5b4c2e58ab9a.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 59450-947-30 59450094730 177 mL in 1 TUBE (59450-947-30) 177 ml 2024-10-29 No No Current