COOLA Classic Liplux Lip Balm SPF 30 - Tinted

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]

COOLA CLASSIC LIPLUX LIP BALM SPF 30 TINTED- 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 - Tinted

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), 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

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

Call 760-940-2125

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COOLA CLASSIC LIPLUX LIP BALM SPF 30 TINTED 
avobenzone, octisalate, octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79753-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
SWEET POTATO (UNII: M9WGG9Z9GK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ACACIA (UNII: 5C5403N26O)  
RADISH (UNII: EM5RP35463)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79753-019-011 in 1 CARTON07/01/2021
14.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02007/01/2021
Labeler - COOLA, LLC (956990290)

Revised: 12/2022

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