Home NDC 79753-076 COOLA Classic Body Sunscreen Tropical Coconut
Product NDC 79753-076
11-digit product format 797530076
Labeler code 79753
Product ID 79753-076_a0a84e34-88b1-43ef-9dc6-d375e69d71c2
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 15; 37.5; 22.5; 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 Body Sunscreen Tropical Coconut
Brand name suffix SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 15 mg/mL OCTOCRYLENE 37.5 mg/mL HOMOSALATE 22.5 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79753-076-01 COOLA Classic Body Sunscreen Tropical CoconutSPF 30 148 mL in 1 TUBE LOTION 148 2 79753-076-01 COOLA Classic Body Sunscreen Tropical CoconutSPF 30 1 in 1 CARTON LOTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-076 COOLA CLASSIC BODY SUNSCREEN TROPICAL COCONUT SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA LLC] 2 Current NDC, 2 package rows 20241228_55ad5d2f-a855-491e-a287-13689f8abff1.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 79753-076-01 79753007601 1 TUBE in 1 CARTON (79753-076-01) / 148 mL in 1 TUBE 1 tube 2023-02-01 No No Current