Home NDC 79753-019 COOLA Classic Liplux Lip Balm SPF 30 Tinted
Product NDC 79753-019
11-digit product format 797530019
Labeler code 79753
Product ID 79753-019_2e947974-f005-ecaa-e063-6294a90ad877
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 2021-07-01
Substance OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength 7.6; 4.9; 2.9 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 Tinted
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 7.6 g/100g OCTISALATE 4.9 g/100g AVOBENZONE 2.9 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup 4X49Y0596W Internal UNII lookup G63QQF2NOX 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 79753-019-01 COOLA Classic Liplux Lip Balm SPF 30 Tinted 4.2 g in 1 TUBE STICK 4.2 6 79753-019-01 COOLA Classic Liplux Lip Balm SPF 30 Tinted 1 in 1 CARTON STICK 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-019 COOLA CLASSIC LIPLUX LIP BALM SPF 30 TINTED (AVOBENZONE, OCTISALATE, OCTOCRYLENE) STICK [COOLA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20250223_eec6e7c8-17fe-f34b-e053-2995a90a78a0.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 242 of 353 · 7,041 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 79753-019-01 79753001901 1 TUBE in 1 CARTON (79753-019-01) / 4.2 g in 1 TUBE 1 tube 2021-07-01 0000-00-00 No No Current