Home NDC 79753-067 COOLA Classic Liplux Lip Balm SPF 30 Original
Product NDC 79753-067
11-digit product format 797530067
Labeler code 79753
Product ID 79753-067_190de8e0-4ba5-fb2f-e063-6294a90a9a2f
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octisalate, Octocrylene
Dosage form STICK
Route TOPICAL
Labeler COOLA, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-01
Substance OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength 4.9; 2.9; 7.6 g/100g; g/100g; g/100g
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 Liplux Lip Balm SPF 30 Original
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 4.9 g/100g AVOBENZONE 2.9 g/100g OCTOCRYLENE 7.6 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4X49Y0596W Internal UNII lookup G63QQF2NOX 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 79753-067-01 COOLA Classic Liplux Lip Balm SPF 30 Original 1 in 1 CARTON STICK 1 3 79753-067-01 COOLA Classic Liplux Lip Balm SPF 30 Original 4.2 g in 1 TUBE STICK 4.2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-067 COOLA CLASSIC LIPLUX LIP BALM SPF 30 ORIGINAL (AVOBENZONE, OCTISALATE, OCTOCRYLENE) STICK [COOLA, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240524_eeb420f0-c92f-0d96-e053-2a95a90afe36.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 Marketing end Sample Exclude flag Status 79753-067-01 79753006701 1 TUBE in 1 CARTON (79753-067-01) / 4.2 g in 1 TUBE 1 tube 2021-02-01 0000-00-00 No No Current