COOLA CLASSIC BODY SPF 30 TROPICAL COCONUT- avobenzone, octisalate, octocrylene spray 
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.

----------

Coola Classic Body Spray SPF 30 - Tropical Coconut

Avobenzone - 2.8%
Octisalate - 4.9%
Octocrylene - 7.6%

Sunscreen

Uses

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Alcohol (ORGANIC), Butyloctyl Salicylate, Methyl Dihydroabietate, Aloe Barbadensis Leaf Juice, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Opuntia Ficus-Indica Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Citric Acid, Dimethyl Heptenal, Gamma-Nonalactone, Sodium Benzoate, Maltol, Potassium Sorbate, Trans-2-hexenal, Triethyl Citrate, Vanillin, 5-Butyldihydro-2(3H)-Furanone

Call 760-940-2125

1

COOLA CLASSIC BODY SPF 30 TROPICAL COCONUT 
avobenzone, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MALTOL (UNII: 3A9RD92BS4)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
2-HEXENAL, (2E)- (UNII: 69JX3AIR1I)  
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)  
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)  
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)  
VANILLIN (UNII: CHI530446X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-062-01177 mL in 1 CAN; Type 0: Not a Combination Product10/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02010/01/2019
Labeler - COOLA, LLC (956990290)

Revised: 11/2022
Document Id: ed2246ed-eec8-e1af-e053-2995a90ad2e9
Set id: ed0f8249-aba8-b67c-e053-2a95a90af7eb
Version: 2
Effective Time: 20221110
 
COOLA, LLC