COOLA CLASSIC SUNSCREEN FRAGRANCE FREE- avobenzone, homosalate, octisalate, octocrylene lotion 
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 SUNSCREEN LOTION FRAGRANCE-FREE

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 4.5%

Octocrylene 8.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

-limit time in the sun, especially from 10 a.m.-2 p.m.

-wear long-sleeved shirts, pants, hats, and sunglasses

Other information

Inactive Ingredients

Alkyl Heptoate, Behenyl Alcohol, Butylated PVP, Butylene Glycol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Disodium EDTA, Ethylhexylglycerin, Gamma-Decalactone, Gamma-Nonalactone, Glycerin, Glyceryl Stearate, Heliotropine, Lauryl Alcohol, Lecithin, Linum Usitatissimum (Linseed) Seed Oil, Lycium Barbarum Fruit Extract, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Phenoxyethanol, Propylene Glycol, Raspberry Ketone, Rubus Idaeus (Raspberry) Seed Extract, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Triethyl Citrate, Vanillin, Water (Aqua)

Label

CA61410

CA00770

CA00761

COOLA CLASSIC SUNSCREEN FRAGRANCE FREE 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-045
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MONARDA DIDYMA LEAF (UNII: JY15982UBB)  
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)  
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
ALLYL HEPTANOATE (UNII: AU4CYG9V68)  
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PALMITIC ACID (UNII: 2V16EO95H1)  
LAURYL ALCOHOL (UNII: 178A96NLP2)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PIPERONAL (UNII: KE109YAK00)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%) (UNII: 4J4P6L645M)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
DOCOSANOL (UNII: 9G1OE216XY)  
VANILLIN (UNII: CHI530446X)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LINSEED OIL (UNII: 84XB4DV00W)  
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)  
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-045-72946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2018
Labeler - COOLA, LLC (956990290)

Revised: 11/2021
Document Id: cfeaf245-41af-644d-e053-2995a90a4a34
Set id: cfc21b1a-4a26-1573-e053-2995a90a2d50
Version: 2
Effective Time: 20211101
 
COOLA, LLC