COOLA CLASSIC BODY SUNSCREEN GUAVA MANGO BROAD SPECTRUM SPF 50- avobenzone homosalate octisalate octocrylene lotion

COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum by

Drug Labeling and Warnings

COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum 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,
Flavor*, 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
                                  Guava Mango

                                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
   *Naturally derived. See coola.com for additional detail.

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.
         Questions or Comments? Call 760-940-2125
                              www.coola.com

Box

Tube

res

INGREDIENTS AND APPEARANCE

COOLA CLASSIC BODY SUNSCREEN GUAVA MANGO BROAD SPECTRUM  SPF 50
avobenzone homosalate octisalate octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-142
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 FLOWER (UNII: 83YSP51SMA)
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)
PHYTATE SODIUM (UNII: 88496G1ERL)
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: 54111-142-50	1 in 1 CARTON	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)