COOLA CLASSIC FACE SUNSCREEN FRAGRANCE-FREE SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

COOLA Classic Face Sunscreen Fragrance-Free by

Drug Labeling and Warnings

COOLA Classic Face Sunscreen Fragrance-Free by is a Otc medication manufactured, distributed, or labeled by COOLA LLC, Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

AVOBENZONE 1.75%, HOMOSALATE 5.0%, OCTISALATE 2.0%, OCTOCRYLENE 5.0%

PURPOSE

Purpose  

Sunscreen

INDICATIONS & USAGE

Uses

* helps prevent sunburn

* if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun

WARNINGS AND PRECAUTIONS

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 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.

DOSAGE & ADMINISTRATION

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

* Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleve shirts, pants, hats, and sunglasses

* children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Aloe Barbadensis Leaf Juice (ORGANIC),
Carthamus Tinctorius (Safflower) Oleosomes,
Water, Carthamus Tinctorius (Safflower) Seed Oil
(ORGANIC), Glycerin (ORGANIC), Polyacrylate
Crosspolymer-6, Limnanthes Alba
(Meadowfoam) Seed Oil, Mauritia Flexuosa
(Buriti) Fruit Oil, Rubus Idaeus (Raspberry) Seed
Oil, Squalane, Brassica Campestris (Rapeseed)
Seed Oil, Opuntia Ficus-Indica Flower Extract,
Camelina Sativa Seed Oil, Tropolone, Cetyl
Palmitate, Sodium Hydroxide, Citric Acid,
Cetearyl Alcohol, Caprylyl Glycol,
1,2-Hexanediol, Sorbitan Palmitate, Methyl
Dihydroabietate, Xanthan Gum, Dimethicone,
Sorbitan Oleate, Gluconolactone, Silica, Sodium
Phytate, Sodium Benzoate, Polysilicone-11,
Butylene Glycol, Decyl Glucoside

OTHER SAFETY INFORMATION

Other Information

* protect this product from excessive heat and direct sun

* may stain fabrics

QUESTIONS

Questions or comments? Call 760-940-2125

Product Labeling - COOLA Classic Face Sunscreen Fragrance-Free SPF 50

SPF
50

70% +
Organic

COOLA

Classic
Face Sunscreen
FragranceiFree

Broad Spectrum SPF 50
Water Resistant (80 Minutes)

1.7 FL OZ / 50 mL

2022 COOLA. Manufactured in the USA forDistributed by: COOLA LLC,

COOLA LLC, located in Sunny& Cool San Diego,

CA 92009. All Rights Reserved. ww.coola.com

Carton

Tube

INGREDIENTS AND APPEARANCE

COOLA CLASSIC FACE SUNSCREEN FRAGRANCE-FREE  SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	17.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
TROPOLONE (UNII: 7L6DL16P1T)
PHYTATE SODIUM (UNII: 88496G1ERL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SQUALANE (UNII: GW89575KF9)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
RASPBERRY SEED OIL (UNII: 9S8867952A)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
CARTHAMUS TINCTORIUS SEEDCAKE (UNII: DHQ13F4N2W)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
GLYCERIN (UNII: PDC6A3C0OX)
SAFFLOWER OIL (UNII: 65UEH262IS)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-074-01	1 in 1 CARTON	02/01/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2023

Labeler - COOLA LLC (956990290)

Registrant - Bentley Laboratories, LLC (068351753)