COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100- avobenzone, homosalate, octisalate, octocrylene spray

COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100 by

Drug Labeling and Warnings

COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100 by is a Otc medication manufactured, distributed, or labeled by COOLA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

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

FLAMMABLE:

do not use near heat, flame or while smoking

avoid long term storage above 104°F (40°C)

Do not use

• on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove. do not puncture or incinerate. Contents under pressure. do not store at temperatures above 120° F.

​Stop use and ask doctor if​

• rash occurs.

Keep out of reach of children.

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

Directions

spray liberally and spread evenly 15 minutes before sun exposure

hold can 4-6 inches away fromskin to apply

do not spray into face. Spray into hand and apply to face.

• Do not apply in windy conditions

use in well ventilated, but not windy areas

reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

• children under 6 months: Ask a doctor

• 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 value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

protect the product in this container from excessive heat and direct sun
may stain or damage some fabrics, materials or surfaces

Inactive ingredients

SD Alcohol 40-B, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Octylacrylamide Copolymer, Diisopropyl Sebacate, Lauryl Lactate, Fragrance (Natural Fragrance), Caprylic/Capric Triglyceride, Glycerin, Rubus Idaeus (Red Raspberry) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil

Label

INGREDIENTS AND APPEARANCE

COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ALCOHOL (UNII: 3K9958V90M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
RASPBERRY SEED OIL (UNII: 9S8867952A)
LAURYL LACTATE (UNII: G5SU0BFK7O)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CARROT SEED OIL (UNII: 595AO13F11)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-023-01	170 g in 1 CAN; Type 0: Not a Combination Product	09/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/23/2021

Labeler - COOLA, LLC (956990290)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(79753-023)