Home NDC 11344-109 Sunscreen SPF 30
Product NDC 11344-109
11-digit product format 113440109
Labeler code 11344
Product ID 11344-109_4cd62cba-075b-7448-e063-6394a90ab48d
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Nice-Pak Products, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-01
Substance HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength 100; 50; 70; 30 mg/g; 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 Sunscreen SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 100 mg/g OCTISALATE 50 mg/g OCTOCRYLENE 70 mg/g AVOBENZONE 30 mg/g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11344-109-14 Sunscreen SPF 30 156 g in 1 CAN SPRAY 156 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11344-109 SUNSCREEN SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [CONSUMER PRODUCT PARTNERS, LLC] 1 Current NDC, 1 package rows 20240302_08237b4c-4e5c-4b12-9510-2f8d64ab7f3a.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 11344-109-14 11344010914 156 g in 1 CAN (11344-109-14) 156 g 2024-03-01 No No Current