Home NDC 79753-057 COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush
Product NDC 79753-057
11-digit product format 797530057
Labeler code 79753
Product ID 79753-057_106b77f6-5900-2120-e063-6294a90af8d0
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler COOLA, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-02-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 3.6; 3 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 Mineral Liplux Lip Balm SPF 30 Summer Crush
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 3.6 g/100g ZINC OXIDE 3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79753-057-01 COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush 4.2 g in 1 TUBE STICK 4.2 4 79753-057-01 COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush 1 in 1 CARTON STICK 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-057 COOLA MINERAL LIPLUX LIP BALM SPF 30 SUMMER CRUSH (ZINC OXIDE) STICK [COOLA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240203_edc6754e-dabb-5bff-e053-2a95a90a7390.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 79753-057-01 79753005701 1 TUBE in 1 CARTON (79753-057-01) / 4.2 g in 1 TUBE 1 tube 2019-02-01 0000-00-00 No No Current