COOLA CLEAR CALIFORNIA SUMMERS- octocrylene avobenzone octisalate homosalate spray

Coola Clear California Summers by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone 2.9%, Homosalate 4.0%, Octisalate 4.9%, Octocrylene 9.5%

PURPOSE

Purpose

Sunscreeen

INDICATIONS & USAGE

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

Warnings

For external use only

Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures about 120ºF. Do not use in the presence of a flame or spark, or while smoking.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

WHEN USING

When using this product keep away from face to avoid breaking. Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as it could cause surface to become slippery. Do not apply in windy conditions. Use in a well-venitilated area.

STOP USE

Stop use and ask doctor if skin rash occurs.

DO NOT USE

Do not use on damaged or broken skin.

DOSAGE & ADMINISTRATION

Shake Well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. -Reapply: -After 80 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 this risk, regularly use a sunscreen with a broad specturm SPF of 15 or higher and other sun protection measures including: -Limit time in the sun, especially from: 10am - 2pm. -Wear long sleeve shirt, pants, hat and sunglasses -Children under 6 months; Ask a doctor

QUESTIONS

Questions or comments? Call 760-940-2125

INACTIVE INGREDIENT

Alcohol (ORGANIC), Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuose (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Ethyl Ferulate, Fragrance (Natural)

OTHER SAFETY INFORMATION

Other Information -May stain fabrics -Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLA CLEAR CALIFORNIA SUMMERS 
octocrylene avobenzone octisalate homosalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.08 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	71.25 g  in 100 g
OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)	0.002 g  in 100 g
MONOISOBUTYL MALEATE (UNII: KDC7836164)	1 g  in 100 g
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)	4.8 g  in 100 g
RUBUS IDAEUS (RASPBERRY) SEED OIL (UNII: 9S8867952A)	0.01 g  in 100 g
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)	0.002 g  in 100 g
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS)	0.01 g  in 100 g
ETHYL FERULATE (UNII: 5B8915UELW)	0.7 g  in 100 g
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL (UNII: 412ZHA4T4Y)	0.01 g  in 100 g
BRASSICA CAMPESTRIS (RAPESEED) SEED OIL (UNII: N4G8379626)	0.006 g  in 100 g
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)	0.01 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-104-01	140 g in 1 CAN; Type 0: Not a Combination Product	05/19/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/19/2025

Labeler - COOLA, LLC (956990290)