COOLA MINERAL BODY SPF 30 TROPICAL COCONUT- zinc oxide lotion

COOLA Mineral Body SPF 30 Tropical Coconut by

Drug Labeling and Warnings

COOLA Mineral Body 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

Zinc Oxide - 14.2%

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
• 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 a 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
• Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours
• Sun Protection Measure: 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses.

INACTIVE INGREDIENT

Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), Cocos Nucifera (Coconut) Oil (ORGANIC), Butyloctyl Salicylate, Cetearyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Methyl Dihydroabietate, Sodium Stearoyl Glutamate, Coco-Glucoside, Acacia Senegal Gum (ORGANIC), Caesalpinia Spinosa Gum (ORGANIC), Sodium Hyaluronate, Glycerin, Laminaria Digitata Extract (ORGANIC), Butyrospermum Parkii (Shea) Butter (ORGANIC), Theobroma Cacao (Cocoa) Seed Butter (ORGANIC), Bisabolol (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Mauritia Flexuosa Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Persea Gratissima (Avocado) Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Opuntia Ficus-Indica Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Caprylhydroxamic Acid, Caprylyl Glycol, Sodium Gluconate, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Water, Citric Acid, Gamma-Nonalactone, Gamma-Octalactone, Caprylic/Capric Triglyceride, Trans-2-hexenal, Vanillin, Maltol, Dimethyl Heptenal

OTHER SAFETY INFORMATION

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

QUESTIONS

Call 760-940-2125

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLA MINERAL BODY SPF 30 TROPICAL COCONUT 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ACACIA (UNII: 5C5403N26O)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
VANILLIN (UNII: CHI530446X)
OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
COCO GLUCOSIDE (UNII: ICS790225B)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)
COCONUT OIL (UNII: Q9L0O73W7L)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
MALTOL (UNII: 3A9RD92BS4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
SAFFLOWER OIL (UNII: 65UEH262IS)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
DOCOSANOL (UNII: 9G1OE216XY)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ORANGE (UNII: 5EVU04N5QU)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
RASPBERRY SEED OIL (UNII: 9S8867952A)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
2-HEXENAL, (2E)- (UNII: 69JX3AIR1I)
ROSEMARY (UNII: IJ67X351P9)
SUNFLOWER OIL (UNII: 3W1JG795YI)
AVOCADO OIL (UNII: 6VNO72PFC1)
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-053-01	1 in 1 CARTON	11/01/2019
1		148 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 79753-053-02	1 in 1 CARTON	11/01/2019
2		100 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	M020	11/01/2019

Labeler - COOLA, LLC (956990290)