Home NDC 11344-943 Avobenzone, Homosalate, Octisalate
Product NDC 11344-943
11-digit product format 113440943
Labeler code 11344
Product ID 11344-943_4ceb123b-d7bf-f068-e063-6394a90af7a1
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate
Dosage form SPRAY
Route TOPICAL
Labeler Nice-Pak Products, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-08
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength 30; 120; 50 mg/g; mg/g; mg/g
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/g HOMOSALATE 120 mg/g OCTISALATE 50 mg/g
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 11344-943-34 Avobenzone, Homosalate, Octisalate 156 g in 1 BOTTLE, SPRAY SPRAY 156 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11344-943 AVOBENZONE, HOMOSALATE, OCTISALATE SPRAY [CONSUMER PRODUCT PARTNERS, LLC] 1 Current NDC, 1 package rows 20241109_af052521-bfa6-4142-a10b-ef51f474a077.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 11344-943-34 11344094334 156 g in 1 BOTTLE, SPRAY (11344-943-34) 156 g 2024-11-08 No No Current