COOLA BARE REPUBLIC CLEARSCREEN SPF50- avobenzone, homosalate, octisalate, octocrylene lotion

COOLA BARE REPUBLIC CLEARSCREEN SPF50 by

Drug Labeling and Warnings

COOLA BARE REPUBLIC CLEARSCREEN SPF50 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 9.0%

Octisalate 4.0%

Octocrylene 5.0%

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

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash occurs.

Keep out of the reach of children

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

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

• children under 6 months of age: 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 this product from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

Behenyl Alcohol, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Gluoside, Cetearyl Olivate, Cetyl Palmitate, Chlorophenesin, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium Hyaluronate, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Sorbitan Palmitate, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl (Vitamin E), Vitis Vinifera (Grape) Seed Oil, VP/Hexadecene Copolymer, Water, Xanthan Gum

Label

INGREDIENTS AND APPEARANCE

COOLA BARE REPUBLIC CLEARSCREEN SPF50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL PALMITATE (UNII: 5ZA2S6B08X)
WATER (UNII: 059QF0KO0R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CETYL ALCOHOL (UNII: 936JST6JCN)
RASPBERRY SEED OIL (UNII: 9S8867952A)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHLORPHENESIN (UNII: I670DAL4SZ)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARROT SEED OIL (UNII: 595AO13F11)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITAN OLIVATE (UNII: MDL271E3GR)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
GRAPE SEED OIL (UNII: 930MLC8XGG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHYTATE SODIUM (UNII: 88496G1ERL)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-014-71	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

Labeler - COOLA, LLC (956990290)