Home NDC 79753-045 COOLA CLASSIC SUNSCREEN FRAGRANCE FREE
Product NDC 79753-045
11-digit product format 797530045
Labeler code 79753
Product ID 79753-045_45ede361-ecc1-0474-e063-6294a90a9c2d
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler COOLA, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-01
Substance HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength 100; 30; 80; 45 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 COOLA CLASSIC SUNSCREEN FRAGRANCE FREE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 100 mg/mL AVOBENZONE 30 mg/mL OCTOCRYLENE 80 mg/mL OCTISALATE 45 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 79753-045-72 COOLA CLASSIC SUNSCREEN FRAGRANCE FREE 946 mL in 1 BOTTLE LOTION 946 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-045 COOLA CLASSIC SUNSCREEN FRAGRANCE FREE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241025_cfc21b1a-4a26-1573-e053-2995a90a2d50.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 109 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 79753-045-72 79753004572 946 mL in 1 BOTTLE (79753-045-72) 946 ml 2018-01-01 0000-00-00 No No Current