FDA.reportPublic FDA data

COOLA Liplux Hydrating Oil SPF 30

Product NDC
79753-018
11-digit product format
797530018
Labeler code
79753
Product ID
79753-018_20808356-02e6-4e90-8228-085e5b2f2ee0
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
OIL
Route
TOPICAL
Labeler
COOLA LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-22
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 4; 4; 10 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COOLA Liplux Hydrating Oil SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE4 g/100mL
OCTISALATE4 g/100mL
OCTOCRYLENE10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-018-01COOLA Liplux Hydrating Oil SPF 301 in 1 CARTONOIL12
79753-018-01COOLA Liplux Hydrating Oil SPF 303.2 mL in 1 BOTTLEOIL3.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-018COOLA LIPLUX HYDRATING OIL SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [COOLA LLC]2Current NDC, Legacy NDC, 2 package rows20231221_2d2ad94c-ea13-43c0-ab7f-acecf4d2309f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-018-01797530018011 BOTTLE in 1 CARTON (79753-018-01) / 3.2 mL in 1 BOTTLE1 bottle2020-12-220000-00-00NoNoCurrent