FDA.reportPublic FDA data

COOLA Liplux Hydrating Oil SPF 30

Manufacturer
COOLA LLC
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:04

Label at a glance#

ProductCOOLA Liplux Hydrating Oil SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 10.0%

OTC - PURPOSE SECTION

Purpose

Suncreen

INDICATIONS & USAGE SECTION

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures 

(see Directions), decreases the risk of skin cancer and

early skin aging caused by the sun

WARNINGS SECTION

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.

OTC - STOP USE SECTION

Stop use and ask doctor if skin rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If product is swallowed, get

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions - Apply liberally 15 minutes before sun exposure & again after swimming or sweating. Apply at least every 2 hours.
Sun Protection Measures - To decrease your risk of cancer and early skin aging. Regularly use a sunscreen with a broad
spectrum SPF of 15 or higher and other sun protection
measures including: limit time in the sun, especially from: 10 a.m. - 2 p.m. and wear
long-sleeve shirts, pants, hats, and sunglasses.  Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients-​​Adipic Acid/Diglycol Crosspolymer,Camellia Oleifera Seed Oil (ORGANIC),Caprylic/Capric Triglyceride,Ethylhexylmethoxycrylene,Flavor,Glyceryl Caprylate,Helianthus Annus (Sunflower) Seed Oil (ORGANIC),Polyglyceryl-3 Diisostearate,Polyurethane-79,Punica Granatum Flower Extract,Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC),Sodium Saccharin,Tocopheryl Acetate

OTHER SAFETY INFORMATION

Other information

  • protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments?
Call 760-940-2125

COOLA Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF

30

70%+

Organic

COOLA​®

Liplux®

Hydrating Oil

​Golden Glow

Nourishes & Protects​​

Broad Spectrum SPF 30

0.11 FL OZ / 3.2 mL

©2021 COOLA. Distributed by: COOLA LLC, located in

Sunny & Cool San Diego, CA 92010.

Carton

COOLA BENTLYCOOLA BENTLY

Bottle

coola bottlecoola bottle

res

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-01879753-018-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)R9TPS68K19IACT
CAMELLIA OILT1PE06G0VEIACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
SUNFLOWER OIL3W1JG795YIIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PUNICA GRANATUM FLOWERD9B634V4GPIACT
JOJOBA OIL724GKU717MIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Liplux Hydrating Oil SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC2d2ad94c-ea13-43c0-ab7f-acecf4d2309f2023-12-20WarningsExact identifier
ndc (package): 79753-018-01
ndc (product): 79753-018
ndc11 (package): 79753001801
spl id: 20808356-02e6-4e90-8228-085e5b2f2ee0
spl set id: 2d2ad94c-ea13-43c0-ab7f-acecf4d2309f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.