Home NDC 54111-148 COOLA Refreshing Water Mist SPF 18
Product NDC 54111-148
11-digit product format 541110148
Labeler code 54111
Product ID 54111-148_aae99fc7-d6b1-44fc-a2d8-0004df757b85
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Bentley Laboratories, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-30
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 2; 10; 5; 5.5 g/100mL; g/100mL; g/100mL; g/100mL
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 COOLA Refreshing Water Mist SPF 18
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2 g/100mL HOMOSALATE 10 g/100mL OCTISALATE 5 g/100mL OCTOCRYLENE 5.5 g/100mL
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 54111-148-50 COOLA Refreshing Water Mist SPF 18 1 in 1 CARTON SPRAY 1 3 54111-148-50 COOLA Refreshing Water Mist SPF 18 50 mL in 1 BOTTLE SPRAY 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54111-148 COOLA REFRESHING WATER MIST SPF 18 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [BENTLEY LABORATORIES, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20231220_658bf3fe-2246-40b6-8cb1-969bfdaffd1b.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 54111-148-50 54111014850 1 BOTTLE in 1 CARTON (54111-148-50) / 50 mL in 1 BOTTLE 1 bottle 2020-07-30 2023-12-31 No No Current