CLASSIC SPORT UNSCENTED SPF 30 BROAD SPECTRUM- sunscreen lotion 
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 50 Classic Sport Sunscreen Lotion Unscented

Active Ingredient

Avobenzone 2.8%, Octinoxate 4.7%, Octisalate 4.9%, Octocrylene 7.7%

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. Rinse with water to remove.

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

reapply:

  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, 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 10am-2pm
  • wear long-sleeve shirts, pants, hats and sunglasses

Children under 6 months: Ask a doctor

Inactive Ingredients

Agave Americana Leaf Extract (ORGANIC), Alcohol (ORGANIC), Arnica Montana Flower Extract (ORGANIC), Beeswax (ORGANIC), Citric Acid, Citrus Aurantium Dulcis (ORGANIC Orange) Fruit Water, Dicaprylyl Carbonate, Glycerin (ORGANIC), Hydrogenated Methyl Abietate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Limum Usitatissimum (ORGANIC Linseed) Seed Oil, Persea Gratissima (ORGANIC Avocado) Oil, Plankton Extract, Sodium Stearoyl Glutamate, Sorbitol/Sebacic Acid Copolymer Behenate, Tocopherol, Trisodium Ethylenediamine Disuccinate, Xanthan Gum

Other information

Protect this product from excessive heat and direct sun

PDP

PDP

CLASSIC SPORT UNSCENTED  SPF 30 BROAD SPECTRUM
sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-141
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.7 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.7 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
SOYBEAN OIL (UNII: 241ATL177A)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
ORANGE (UNII: 5EVU04N5QU)  
LINSEED OIL (UNII: 84XB4DV00W)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALCOHOL (UNII: 3K9958V90M)  
AGAVE AMERICANA LEAF (UNII: 8511ZMP5QK)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76150-141-10148 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201501/01/2021
Labeler - Bell International Laboratories, Inc (967781555)

Revised: 1/2021
 
Bell International Laboratories, Inc