COOLA CLEAR SKIN OIL-FREE MOISTURIZER SPF 30- zinc oxide sunscreen cream

COOLA Clear Skin Oil-Free Moisturizer SPF 30 by

Drug Labeling and Warnings

COOLA Clear Skin Oil-Free Moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by COOLA LLC, Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Zinc Oxide 14.7%

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.

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 at least every 2 hours
● use a water resistant sunscreen if swimming or sweating
● 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 INGREDIENT

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Caprylic/Capric
Triglyceride (ORGANIC), Glycerin (ORGANIC), Glyceryl
Stearate Citrate, Niacinamide, Butylene Glycol, Butyloctyl
Salicylate, Ethylhexyl Methoxycrylene, Hydroxyethyl
Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,
Water, Jasminum Sambac (Jasmine) Leaf Cell Extract,
Theobroma Cacao (Cocoa) Seed Extract, Centella Asiatica
Leaf Extract, Tropolone, Schinus Molle Extract, Isostearic
Acid, Citric Acid (ORGANIC), Polyhydroxystearic Acid,
Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer,
Isoamyl Laurate, 1,2-Hexanediol, Caprylyl Glycol,
Tocopheryl Acetate, Sodium Phytate

OTHER SAFETY INFORMATION

Other information

• protect this product from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

Questions or comments?
Call 760-940-2125

COOLA Clear Skin Oil-Free Moisturizer SPF 30 Label

COOLA

Clear Skin

Oil-Free Moisturizer

Zinc Oxide Sunscreen

Broad Spectrum SPF 30

1.1 FL OZ / 33 mL

© 2024 COOLA

Manufactured in the USA for

COOLA LLC, locatedin sunny

San Diego, CA 92009.

All Rights Reserved.

www.coola.com

res

INGREDIENTS AND APPEARANCE

COOLA CLEAR SKIN OIL-FREE MOISTURIZER SPF 30 
zinc oxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	14.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
WATER (UNII: 059QF0KO0R)
JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
COCOA (UNII: D9108TZ9KG)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
TROPOLONE (UNII: 7L6DL16P1T)
SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)
ISOSTEARIC ACID (UNII: X33R8U0062)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHYTATE SODIUM (UNII: 88496G1ERL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-080-01	1 in 1 CARTON	01/01/2024
1		33 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2024

Labeler - COOLA LLC (956990290)

Registrant - Bentley Laboratories, LLC (068351753)