Home NDC 79753-074 COOLA Classic Face Sunscreen Fragrance-Free
Product NDC 79753-074
11-digit product format 797530074
Labeler code 79753
Product ID 79753-074_684dd468-00d8-4824-8dd5-17a82f596573
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 2023-02-01
Substance OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength 20; 50; 50; 17.5 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 Face Sunscreen Fragrance-Free
Brand name suffix SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 20 mg/mL OCTOCRYLENE 50 mg/mL HOMOSALATE 50 mg/mL AVOBENZONE 17.5 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79753-074-01 COOLA Classic Face Sunscreen Fragrance-FreeSPF 50 1 in 1 CARTON LOTION 1 3 79753-074-01 COOLA Classic Face Sunscreen Fragrance-FreeSPF 50 50 mL in 1 TUBE LOTION 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-074 COOLA CLASSIC FACE SUNSCREEN FRAGRANCE-FREE SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA LLC] 3 Current NDC, 2 package rows 20241228_12ff4689-f7e2-49db-8848-608c61b41ef0.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 79753-074-01 79753007401 1 TUBE in 1 CARTON (79753-074-01) / 50 mL in 1 TUBE 1 tube 2023-02-01 No No Current