COOLA CLASSIC BODY SPF 50 FRAGRANCE FREE- avobenzone, homosalate, 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.

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Coola Classic Body Spray SPF 50 - Unscented

Avobenzone - 2.9%

Homosalate - 4.3%

Octisalate - 4.9%
Octocrylene - 9.5%

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, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Ethyl Ferulate

Call 760-940-2125

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COOLA CLASSIC BODY SPF 50 FRAGRANCE FREE 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)  
VINYL ACETATE (UNII: L9MK238N77)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
ETHYL FERULATE (UNII: 5B8915UELW)  
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-060-01177 mL in 1 CAN; Type 0: Not a Combination Product10/01/2019
2NDC:79753-060-0260 mL in 1 CAN; Type 0: Not a Combination Product07/01/2020
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: ed206ad8-bf17-5076-e053-2a95a90a4318
Set id: ed207afe-0b10-74c7-e053-2a95a90a9b87
Version: 1
Effective Time: 20221110
 
COOLA, LLC