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

COOLA Classic Body Sunscreen Fragrance-Free by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

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 risk of skin cancer and
early skin aging caused by the sun.

WARNINGS

Warnings
For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes.
Rinse with water to remove.

STOP USE

Stop use and ask doctor if rash occurs.

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.

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 skin aging. To
decrease this risk, regularly use a sunscreen with a broad
spectrum SPF of 15 or higher and after sun protection.
measures including:
   limit time in the sun, especially from 10 a.m. – 2 p.m.
   wear long-sleeve shirts, pants, hats, and sunglasses.
Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

Other Information

• protect this product from excessive heat and direct sun

QUESTIONS

Questions or Comments? Call 760-940-2125

Package Label

                                      SPF
                                        50

                                     70% +
                                     Organic

                                     COOLA®

                                      Classic
                                Body Sunscreen
                                 Fragrance-Free

                                Ultra Lightweight
                            Hydrates & Nourishes
                              +Plant Protection®

                             Broad Spectrum SPF 50
                        Water Resistant (80 Minutes)

                              5 FL OZ / 148 mL

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

2020 COOLA. Distributed by: COOLA LLC, located in Sunny
& Cool San Diego, CA 92010. BIORUS / EU: 7170 Manage,
   Belgium / UK: London WC2H 9JQ. All Rights Reserved.
                              www.coola.com

Box

Tube

res

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.75 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
OPUNTIA FICUS-INDICA WHOLE (UNII: 23Z87HTQ6P)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
RASPBERRY SEED OIL (UNII: 9S8867952A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DISODIUM PHTHALATE (UNII: QB14YV193C)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
TROPOLONE (UNII: 7L6DL16P1T)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-145-51	1 in 1 BOX	11/06/2019
1		148 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	11/06/2019

Labeler - Bentley Laboratories, LLC (068351753)