Coola SPF 30 Classic Lip Balm Tinted

Tinted Liplux by

Drug Labeling and Warnings

Tinted Liplux by is a Otc medication manufactured, distributed, or labeled by Bell International Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TINTED LIPLUX- spf 30 classic lipstick 
Bell International Laboratories, Inc

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 SPF 30 Classic Lip Balm Tinted

Active Ingredient

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 7.6%

Purpose

Sunscreens

Uses

Helps prevent sunburn. If used as directed wtih 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. If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure & agan 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, especialyl from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

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

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

Call 760-940-2125

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TINTED LIPLUX 
spf 30 classic lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76150-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ROSEMARY (UNII: IJ67X351P9)  
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
CASTOR OIL (UNII: D5340Y2I9G)  
COCONUT OIL (UNII: Q9L0O73W7L)  
JOJOBA OIL (UNII: 724GKU717M)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
LEVOMENOL (UNII: 24WE03BX2T)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
SWEET POTATO (UNII: M9WGG9Z9GK)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
RADISH (UNII: EM5RP35463)  
BEHENYL BEHENATE (UNII: K8NU647RJ0)  
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
REBAUDIOSIDE A (UNII: B3FUD0528F)  
ACACIA (UNII: 5C5403N26O)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76150-315-324.2 g in 1 TUBE; Type 0: Not a Combination Product07/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/21/2021
Labeler - Bell International Laboratories, Inc (967781555)

Revised: 7/2021