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

COOLA Classic Liplux Lip Balm SPF 30 Tinted by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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.

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.

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.

INACTIVE INGREDIENT

Cocos Nucifera (Coconut) Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Euphorbia Cerifera (Candelilla) Wax, Theobroma Grandiflorum Seed Butter (ORGANIC), Ricinus Communis (Castor) Seed Oil (ORGANIC), Tapioca Starch (ORGANIC), Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Butyloctyl Salicylate, Calcium Sodium Borosilicate, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Polyhydroxystearic Acid, Titanium Dioxide, Maltodextrin, Flavor, Bisabolol (ORGANIC), Ipomoea Batatas Tuber Extract, Acacia Senegal Gum, Stevia Rebaudiana Extract, Octyldodecyl Oleate, Iron Oxides, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Citric Acid, Rosa Canina Fruit Extract (ORGANIC), Raphanus Sativus (Radish) Root Extract, Persea Gratissima (Avocado) Oil (ORGANIC), Tetrahexyldecyl Ascorbate, Caprylic/Capric Triglyceride, Tocopherol (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil, Linoleic Acid, Phospholipids, Phytosterols, Aloe Barbadensis Leaf Extract

OTHER SAFETY INFORMATION

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

QUESTIONS

Call 760-940-2125

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-019
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)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
CASTOR OIL (UNII: D5340Y2I9G)
LEVOMENOL (UNII: 24WE03BX2T)
AVOCADO OIL (UNII: 6VNO72PFC1)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)
ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559)
SOY STEROL (UNII: PL360EPO9J)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
ROSEMARY (UNII: IJ67X351P9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SAFFLOWER OIL (UNII: 65UEH262IS)
RASPBERRY SEED OIL (UNII: 9S8867952A)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
SWEET POTATO (UNII: M9WGG9Z9GK)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, TAPIOCA (UNII: 24SC3U704I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ACACIA (UNII: 5C5403N26O)
RADISH (UNII: EM5RP35463)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-019-01	1 in 1 CARTON	07/01/2021
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 Drug	M020	07/01/2021

Labeler - COOLA, LLC (956990290)