COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50- titanium dioxide, zinc oxide lotion

COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50 by

Drug Labeling and Warnings

COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50 by is a Otc medication manufactured, distributed, or labeled by COOLA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 3.5%, Zinc Oxide 7.25%

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 the reach of children

If 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 value 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-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Amyris Balsamifera Bark Oil, Blue-Green (Algae) Extract (ORGANIC), Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Cananga Odorata Flower Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Chlorphenesin, Citrus Paradisi (Grapefruit) Peel Oil, Cocos Nucifera (Coconut) Oil (ORGANIC), Ethylhexylglycerin, Glycerin (ORGANIC), Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Magnesium Sulfate, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Neopentyl Glycol Diheptanoate, Olive Oil Polyglyceryl-6 Esters, Opuntia Ficus-Indica Flower Extract, Pelargonium Graveolens Flower Oil, Polyglyceryl-6 Pentaoleate, Polymethyl Methacrylate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Triethyl Citrate, VP/Hexadecene Copolymer., Water

Other information

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Label

INGREDIENTS AND APPEARANCE

COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	35 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	72.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
COCONUT OIL (UNII: Q9L0O73W7L)
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
GRAPEFRUIT OIL (UNII: YR377U58W9)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CANANGA OIL (UNII: 8YOY78GNNX)
CHLORPHENESIN (UNII: I670DAL4SZ)
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
RASPBERRY SEED OIL (UNII: 9S8867952A)
JOJOBA OIL (UNII: 724GKU717M)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
SAFFLOWER OIL (UNII: 65UEH262IS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
OPUNTIA TUNA FLOWERING TOP (UNII: R4AS8333O2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-040-01	148 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2019
2	NDC: 79753-040-02	100 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2019
3	NDC: 79753-040-72	946 mL in 1 TUBE; Type 0: Not a Combination Product	01/18/2023
4	NDC: 79753-040-03	41 mL in 1 TUBE; Type 0: Not a Combination Product	09/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2019

Labeler - COOLA, LLC (956990290)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(79753-040)