COOLA SPF 50 CLASSIC- sunscreen face mist spray

Coola by

Drug Labeling and Warnings

Coola by is a Otc medication manufactured, distributed, or labeled by COOLA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 9.5%

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 store at temperatures above 120 F.

Do not use in the presence of a flame or spark, or while smoking.

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 doctor if skin rash occurs.

Keep out of reach of children.

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

Directions

SHAKE WELL before use.

With your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face.

Wait until dry.

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes minutes of swimming or sweating

-Immediately after towel drying

-At least every 2 hours

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other protection measures including:

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

-Wear long sleeves shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Inactive Ingredients

Alcohol (ORGANIC), Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Polyester-8, Fragrance (Natural), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Brassica Campestris (Rapeseed) Seed Oil, Camellia Sinensis Leaf Extract (ORGANIC),Glycyrrhiza Glabra (Licorice) Root Extract (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Bisabolol (ORGANIC), Glycerin (ORGANIC), Water, Ethyl Ferulate, Diisooctyl Succinate

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments

Call 760-940-2125

Package Label

INGREDIENTS AND APPEARANCE

COOLA  SPF 50 CLASSIC
sunscreen face mist spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
SAFFLOWER OIL (UNII: 65UEH262IS)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
VINYL ACETATE (UNII: L9MK238N77)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)
DICAPRYL SUCCINATE (UNII: 8XD1ZF2M1M)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
LEVOMENOL (UNII: 24WE03BX2T)
ETHYL FERULATE (UNII: 5B8915UELW)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)
RASPBERRY SEED OIL (UNII: 9S8867952A)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-033-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/02/2021

Labeler - COOLA LLC (956990290)