COOLA SPF 30 MINERAL SUNSCREEN FRAGRANCE FREE- zinc oxide spray

Coola SPF 30 Mineral Sunscreen Fragrance Free by

Drug Labeling and Warnings

Coola SPF 30 Mineral Sunscreen Fragrance Free by is a Otc medication manufactured, distributed, or labeled by COOLA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide - 14.5%

PURPOSE

Sunscreen

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
• Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. Do not use in the presence of a flame or spark, or while smoking.
• Do not use on damaged or broken skin
• When using this product keep away from face to avoid breathing in Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as could cause surface to become slippery. Do not apply in windy conditions. Use in a well ventilated area.
• 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.

Directions

Shake well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. When properly used, mineral sunscreens will leave a whitish tint when first applied.

Reapply: after 80 minutes of swimming or sweating immediately afrer 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

OTHER SAFETY INFORMATION

• May stain fabrics
• Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), WaterSimmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil (ORGANIC), Methyl Dihydroabietate, Bentonite, Cetearyl Alcohol, Aloe Barbadensis Leaf Juice (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Opuntia Ficus-Indica Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Shea Butter Ethyl Esters, Propanediol, Glycerin (ORGANIC), Coco-Glucoside, Laminaria Digitata (Algae) Extract (ORGANIC), Microcrystalline Cellulose, Cellulose Gum, Sodium Stearoyl Glutamate, Caprylhydroxamic Acid, Caprylyl Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Citric Acid

QUESTIONS

Call 760-940-2125

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLA SPF 30 MINERAL SUNSCREEN FRAGRANCE FREE 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
BENTONITE (UNII: A3N5ZCN45C)
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LEVOMENOL (UNII: 24WE03BX2T)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ROSEMARY (UNII: IJ67X351P9)
ORANGE (UNII: 5EVU04N5QU)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERIN (UNII: PDC6A3C0OX)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
JOJOBA OIL (UNII: 724GKU717M)
COCONUT OIL (UNII: Q9L0O73W7L)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
RASPBERRY SEED OIL (UNII: 9S8867952A)
OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-049-01	148 mL in 1 CAN; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/01/2019

Labeler - COOLA, LLC (956990290)