COOLA CLASSIC SUNSCREEN STICK SPF 30 - TROPICAL COCONUT- avobenzone 3.0%, octisalate 4.0%, octocrytene 7.0% stick

COOLA Classic Sunscreen Stick SPF 30 - Tropical Coconut by

Drug Labeling and Warnings

COOLA Classic Sunscreen Stick SPF 30 - Tropical Coconut by is a Otc medication manufactured, distributed, or labeled by COOLA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Avobenzone 3.0%, Octisalate 4.0%, Octocrylene 7.0%

Purpose

Suncreen

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 on damaged or broken skin

When using this product keep out of eyes.

Rinse with water to remove.

Do not use on damaged or broken skin

Stop use and ask doctor if skin 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 spection
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-sleeve shirts, pants, hats, and sunglasses
●Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients
1,2-Hexanediol, Bisabolol, Bis-Octyldodecyl Dimer Dilinoleate/Propanediol Copolymer,
Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Camellia Oleifera
Seed Oil (ORGANIC), Caprylic/Capric Triglyceride (ORGANIC), Carthamus Tinctorius
(Safflower) Seed Oil (ORGANIC), Dimethyl Heptenal*, Gamma-Nonalactone*,
Gamma-Octalactone*, Hydroxystearic Acid, Limnanthes Alba (Meadowfoam) Seed Oil,
Maltol*, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract,
Polyester-8, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Silica Dimethyl Silylate,
Trans-2-Hexenal*, Triethyl Citrate*, VANILLIN* OR VANADIUM*???*

OTHER SAFETY INFORMATION

Other information

• may stain fabrics
• protect this product from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

Questions or comments?
Call 760-940-2125

COOLA Label

SPF

30

70%+

Organic

COOLA​®

Classic

Sunscreen Stick

Tropical Coconut

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

+Plant Protection®

0.6 OZ / 17.0 g

©2021 COOLA. Distributed by: COOLA LLC, located in Sunny &

Cool San Diego, CA 92010.  All Rights Reserved.  www.coola.com

Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
*Plant-derived scent constituent. See coola.com for additional detail.

Carton

Canister

res

INGREDIENTS AND APPEARANCE

COOLA CLASSIC SUNSCREEN STICK SPF 30 - TROPICAL COCONUT 
avobenzone 3.0%, octisalate 4.0%, octocrytene 7.0% stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.0 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LEVOMENOL (UNII: 24WE03BX2T)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)
CAMELLIA OIL (UNII: T1PE06G0VE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
10-HYDROXYSTEARIC ACID (UNII: 384M5B7IFL)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MALTOL (UNII: 3A9RD92BS4)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
OPUNTIA FICUS-INDICA LEAF (UNII: 5VM709H93V)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
RASPBERRY SEED OIL (UNII: 9S8867952A)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
2-HEXENAL, (2E)- (UNII: 69JX3AIR1I)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
VANILLIN (UNII: CHI530446X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-016-01	1 in 1 CARTON	02/08/2021
1		17 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/08/2021

Labeler - COOLA LLC (956990290)