COOLA Classic Liplux Lip Balm SPF 30 - Original

COOLA Classic Liplux Lip Balm SPF 30 Original by

Drug Labeling and Warnings

COOLA Classic Liplux Lip Balm SPF 30 Original by is a Otc medication manufactured, distributed, or labeled by COOLA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COOLA CLASSIC LIPLUX LIP BALM SPF 30 ORIGINAL- avobenzone, octisalate, octocrylene stick 
COOLA, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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COOLA Classic Liplux Lip Balm SPF 30 - Original

Avobenzone – 2.9%
Octisalate – 4.9%
Octocrylene – 7.6%

Sunscreen

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.

• 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. If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure & again after 80 minutes of 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses.

Cocos Nucifera (Coconut) Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Butyloctyl Salicylate, Euphorbia Cerifera (Candelilla) Wax, Theobroma Grandiflorum Seed Butter (ORGANIC), Ricinus Communis (Castor) Seed Oil (ORGANIC), Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Polyhydroxystearic Acid, Bisabolol (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Rosa Canina Fruit Extract (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Caprylic/Capric Triglyceride, Linoleic Acid, Phytosterols, Phospholipids, Persea Gratissima (Avocado) Oil (ORGANIC), Tetrahexyldecyl Ascorbate, Carthamus Tinctorius (Safflower) Seed Oil, Aloe Barbadensis Leaf Extract, Stevia Rebaudiana Extract, Flavor

Protect this product from excessive heat and direct sun. May stain fabrics.

Call 760-940-2125

COOLA CLASSIC LIPLUX LIP BALM SPF 30 ORIGINAL 
avobenzone, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LINOLEIC ACID (UNII: 9KJL21T0QJ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
CASTOR OIL (UNII: D5340Y2I9G)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
LEVOMENOL (UNII: 24WE03BX2T)
AVOCADO OIL (UNII: 6VNO72PFC1)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559)
SOY STEROL (UNII: PL360EPO9J)
ROSEMARY (UNII: IJ67X351P9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SAFFLOWER OIL (UNII: 65UEH262IS)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
RASPBERRY SEED OIL (UNII: 9S8867952A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-067-01	1 in 1 CARTON	02/01/2021
1		4.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	02/01/2021

Labeler - COOLA, LLC (956990290)

Revised: 11/2022

Document Id: eeb420f0-c930-0d96-e053-2a95a90afe36

34390-5

Set id: eeb420f0-c92f-0d96-e053-2a95a90afe36

Version: 1

Effective Time: 20221130

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