Home NDC 79753-082 COOLA Dew Good Illuminating Body Melt SPF 40
Product NDC 79753-082
11-digit product format 797530082
Labeler code 79753
Product ID 79753-082_569a1ea5-3c67-4296-92c7-af9621c809b0
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octisalate, Octocrylene
Dosage form CREAM
Route TOPICAL
Labeler COOLA LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-24
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength 3; 4; 8 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 Dew Good Illuminating Body Melt SPF 40
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100mL OCTISALATE 4 g/100mL OCTOCRYLENE 8 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4X49Y0596W Internal UNII lookup 5A68WGF6WM Internal UNII lookup
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 79753-082-01 COOLA Dew Good Illuminating Body Melt SPF 40 100 mL in 1 TUBE CREAM 100 3 79753-082-02 COOLA Dew Good Illuminating Body Melt SPF 40 7 mL in 1 TUBE CREAM 7 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-082 COOLA DEW GOOD ILLUMINATING BODY MELT SPF 40 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [COOLA LLC] 3 Current NDC, 2 package rows 20240918_43d293f6-e13c-4ee9-89df-2a3ef0034e31.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 45 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 79753-082-01 79753008201 100 mL in 1 TUBE (79753-082-01) 100 ml 2024-06-24 No No Current 79753-082-02 79753008202 7 mL in 1 TUBE (79753-082-02) 7 ml 2024-06-24 No No Current