Home NDC 79753-075 COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum
Product NDC 79753-075
11-digit product format 797530075
Labeler code 79753
Product ID 79753-075_51a93370-03f8-4573-9b72-0fbdf00cf4bf
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 AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 1.75; 5; 2; 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 CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum
Brand name suffix SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 1.75 g/100mL HOMOSALATE 5 g/100mL OCTISALATE 2 g/100mL OCTOCRYLENE 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 79753-075-02 COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad SpectrumSPF 50 100 mL in 1 TUBE LOTION 100 3 79753-075-02 COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad SpectrumSPF 50 1 in 1 CARTON LOTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-075 COOLA CLASSIC BODY SUNSCREEN GUAVA MANGO BROAD SPECTRUM SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [COOLA LLC] 3 Current NDC, 2 package rows 20241228_9a397a2c-4734-4dae-93dd-15c68e6c297d.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 79753-075-02 79753007502 1 TUBE in 1 CARTON (79753-075-02) / 100 mL in 1 TUBE 1 tube 2023-02-01 No No Current