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

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
IngredientStrength
TITANIUM DIOXIDE3.6 g/100g
ZINC OXIDE3 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-057-01COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush4.2 g in 1 TUBESTICK4.24
79753-057-01COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush1 in 1 CARTONSTICK14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-057COOLA MINERAL LIPLUX LIP BALM SPF 30 SUMMER CRUSH (ZINC OXIDE) STICK [COOLA, LLC]4Current NDC, Legacy NDC, 2 package rows20240203_edc6754e-dabb-5bff-e053-2a95a90a7390.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-057-01797530057011 TUBE in 1 CARTON (79753-057-01) / 4.2 g in 1 TUBE1 tube2019-02-010000-00-00NoNoCurrent