COOLA BARE REPUBLIC CLEARSCREEN SPF100- 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.

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COOLA BARE REPUBLIC CLEARSCREEN SPF100 LOTION

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

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

Water, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Dimethicone Copolymer, Behenyl Alcohol, Diisopropyl Sebacate, Lauryl Lactate, Glyceryl Behenatae,Vitis Vinifera (Grape) Seed Extract, Daucus Carota Sativa (Carrot) Extract, Rubus Idaeus (Raspberry) Seed Extract, Sodium Hyaluronate, Glycerin, Ethylhexylglycerin, Chlorphenesin, Polyurethane-62, Silica, Ammonium Acryloyldimethyltaurate/VP Copolymer, Trideceth-6, Tocopherol, Arachidyl Alcohol, Arachidyl Glucoside, Lecithin, Sodium Phytate

Label

BR10223_v03

COOLA BARE REPUBLIC CLEARSCREEN SPF100 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CARROT SEED OIL (UNII: 595AO13F11)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
POLYURETHANE-62 (UNII: TBK645J3J8)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-021-0159 mL in 1 TUBE; Type 0: Not a Combination Product10/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/21/2021
Labeler - COOLA, LLC (956990290)

Revised: 1/2023
Document Id: f14d0b44-0fc5-9633-e053-2a95a90afa6d
Set id: f14cf2b8-b110-1210-e053-2995a90a0102
Version: 1
Effective Time: 20230102
 
COOLA, LLC