COOLA LIPLUX HYDRATING OIL SPF 30- avobenzone, homosalate, octisalate, octocrylene oil

COOLA Liplux Hydrating Oil SPF 30 by

Drug Labeling and Warnings

COOLA Liplux Hydrating Oil SPF 30 by is a Otc medication manufactured, distributed, or labeled by COOLA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

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

Purpose

Suncreen

INDICATIONS & USAGE

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

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.

Stop use and ask doctor if skin rash occurs

KEEP OUT OF REACH OF CHILDREN

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

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

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

QUESTIONS

Questions or comments?
Call 760-940-2125

COOLA Label

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

Bottle

res

INGREDIENTS AND APPEARANCE

COOLA LIPLUX HYDRATING OIL SPF 30 
avobenzone, homosalate, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
CAMELLIA OIL (UNII: T1PE06G0VE)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)
JOJOBA OIL (UNII: 724GKU717M)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-018-01	1 in 1 CARTON	12/22/2020
1		3.2 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/22/2020

Labeler - COOLA LLC (956990290)