COOLA MINERAL SUN SILK CREME SUNSCREEN SPF 30- zinc oxide lotion

COOLA Mineral Sun Silk Creme Sunscreen by

Drug Labeling and Warnings

COOLA Mineral Sun Silk Creme Sunscreen by is a Otc medication manufactured, distributed, or labeled by COOLA LLC, Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredients

Zinc Oxide 15.8%

PURPOSE

Purpose

Sunscreen

WARNINGS AND PRECAUTIONS

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 prodcut is swallowed, get medical help or contact Poison Control Center right away.

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.

DOSAGE & ADMINISTRATION

Directions

* shake well * apply liberally 15 minutes before sun exposure

* reapply: * after 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 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

Water, Caprylic/Capric Triglyceride, Dimethicone,
Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice
Powder, Jasminum Sambac (Jasmine) Leaf Cell
Extract, Theobroma Cacao (Cocoa) Seed Extract,
Schinus Molle Extract, Niacinamide, Hydroxyethyl
Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,
Propanediol, Butylene Glycol, Polyisobutene,
Methylpropanediol, Cetearyl Alcohol, Glyceryl Stearate
Citrate, PEG-7 Trimethylolpropane Coconut Ether,
Caprylyl Glycol, Sorbitan Isostearate,
Polyquaternium-80, Glyceryl Caprylate,
Didecyldimonium Chloride

OTHER SAFETY INFORMATION

Other information

* protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments? Call 760-940-2125

INSTRUCTIONS FOR USE

How to use:

Apply daily to cleansed skin,

15 minutes before sun exposure.

Dispense into palm of hand and

apply evenly across face and

neck using upward strokes,

QUESTIONS

Questionsor Comments? Call 760-940-2125

Package Labeling

SPF

30

COOLA

MINERAL SUN SILK CREME

SUNSCREEN SPF 30

1.5 FL OZ /44 mL

©2021 COOLA. Distributed by: COOLA LLC, located in

Sunny & Cool San Diego, CA 92010. All Rights Reserved.

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INGREDIENTS AND APPEARANCE

COOLA MINERAL SUN SILK CREME SUNSCREEN  SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	158 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCOA (UNII: D9108TZ9KG)
SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
NIACINAMIDE (UNII: 25X51I8RD4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PROPANEDIOL (UNII: 5965N8W85T)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)
POLYQUATERNIUM-80 (UNII: 3N8LGV97HR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-070-01	1 in 1 BOX	02/01/2023
1		44 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 not final	part352	02/01/2023

Labeler - COOLA LLC (956990290)

Registrant - Bentley Laboratories, LLC (068351753)