Drug Facts

Active Ingredients

Zinc Oxide 13.63%

Purpose

Suncreen

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

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.

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 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 Ingredients
Helianthus Annus (Sunflower) Seed Oil (ORGANIC), caprylic/Capric Triglyceride
(ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Ozokerite,
Polymethylsilsesquioxane, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica,
Trimethoxybenzylidene Pentanedione, Butyrospermum Parkii (Shea) Butter (ORGANIC),
1,2-Heanediol Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic
Acid, Limnanthese Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil (ORGANIC),
Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Optuntia Ficus-Indica Seed Oil (ORGANIC)

Other information

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

Questions or comments?
Call 760-940-2125

COOLA Label

SPF

70%+

Organic

COOLA®

Classic

Sunscreen Stick

Fragrance-Free

Broad Spectrum SPF 50

Water-Resistant (80 Minutes)

+Plant Protection®

Net Wt. 0.6 OZ / 17.0 g

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

COOLA 032-Outer

COOLA 032 Inner

res

MINERAL SUNSCREEN STICK SPF 50 FRAGRANCE-FREE
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79753-032
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	13.63 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SUNFLOWER OIL (UNII: 3W1JG795YI)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CERESIN (UNII: Q1LS2UJO3A)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)
SHEA BUTTER (UNII: K49155WL9Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYL FERULATE (UNII: 5B8915UELW)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
RASPBERRY SEED OIL (UNII: 9S8867952A)
OPUNTIA FICUS-INDICA WHOLE (UNII: 23Z87HTQ6P)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79753-032-01	1 in 1 CARTON	01/16/2023
1		17 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/16/2023

Labeler - COOLA LLC (956990290)

COOLA Mineral Sunscreen Stick SPF 50

COOLA Label