Coola Mineral Sun Silk Crème Sunscreen Spf 30

Coola Mineral Sun Silk Crème Sunscreen Spf 30
SPL v2
SPL
SPL Set ID bb9dd9a9-ec01-4e94-9172-3a72e68a417a
Route
TOPICAL
Published
Effective Date 2023-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (158 mg)
Inactive Ingredients
Water Cocoa Schinus Molle Fruiting Top Polyisobutylene (1000 Mw) Polyhydroxystearic Acid (2300 Mw) Niacinamide Methylpropanediol Jasminum Sambac Flower Medium-chain Triglycerides Butylene Glycol Sorbitan Isostearate Propanediol Didecyldimonium Chloride Aloe Vera Leaf Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Dimethicone Caprylyl Glycol Cetostearyl Alcohol Glyceryl Caprylate Glyceryl Stearate Citrate Peg-7 Trimethylolpropane Coconut Ether Polyquaternium-80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-01

Description

Active ingredients Zinc Oxide 15.8%


Medication Information

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.

Indications and 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 cause by the sun.

Dosage and Administration

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

Description

Active ingredients Zinc Oxide 15.8%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask doctor if skin rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Section 51727-6

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

Section 53413-1

Questions or comments? Call 760-940-2125

Section 55105-1

Purpose

Sunscreen

Section 59845-8

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,

Section 60561-8

Other information



* protect this product from excessive heat and direct sun

Drug Facts

Active ingredients

Zinc Oxide 15.8%

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.

res


Structured Label Content

Indications and Usage (34067-9)

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 cause by the sun.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if skin rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or comments? Call 760-940-2125

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 59845-8 (59845-8)

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,

Section 60561-8 (60561-8)

Other information



* protect this product from excessive heat and direct sun

Drug Facts (DRUG FACTS)

Active ingredients

Zinc Oxide 15.8%

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.

res


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