Coola Full Spectrum 360 Day Eye Cream Spf 30

Coola Full Spectrum 360 Day Eye Cream Spf 30
SPL v1
SPL
SPL Set ID 6d707620-6749-443f-b55f-5a77ff602f40
Route
TOPICAL
Published
Effective Date 2021-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.0 g) Homosalate (3.0 g) Octisalate (5.0 g) Octocrylene
Inactive Ingredients
1,2-hexanediol Aloe Vera Flower Aloe Vera Leaf Butylene Glycol Alkyl (c12-15) Benzoate Caprylyl Glycol Carthamus Tinctorius (safflower) Oleosomes Cetostearyl Alcohol Cetyl Palmitate Coccinia Grandis Leaf Corallina Officinalis Turmeric Dimethicone Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Glycerin Isododecane Jasminum Sambac Flower Azadirachta Indica Flower Holy Basil Leaf Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Propanediol Schinus Molle Fruiting Top Silicon Dioxide Sodium Hydroxide Phytate Sodium Sodium Polyacrylate (2500000 Mw) Eggplant Sorbitan Monooleate Sorbitan Monopalmitate Tetrahexyldecyl Ascorbate Cocoa Tropolone Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-08

Description

Drug Facts Active Ingredients Avobenzone 2.0%, Homosalate 2.0%, Octisalate 3.0%, Octocrylene 5.0%


Medication Information

Warnings and Precautions

Warnings

For external use onlyDo 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 product is swallowed, get medical help or contact

a 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 caused by the sun

Dosage and Administration

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 spection 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

Description

Drug Facts Active Ingredients Avobenzone 2.0%, Homosalate 2.0%, Octisalate 3.0%, Octocrylene 5.0%

Section 51727-6

Inactive Ingredients 1,2-HEXANEDIOL, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice

(ORGANIC), Amino Esters-1(JPN), Butylene Glycol, C12-15 Alkyl Benzoate, Caprylyl Glycol, Carthamus Tinctorius

(Safflower) Oleosomes, Cetearyl Alcohol , Cetyl Palmitate, Coccinia Indica Fruit Extract, Corallina Officinalis Extract,

Corallina Officinalis Powder, Curcuma Longa (Turmeric) Root Extract, Dimethicone, Dimethicone Crosspolymer,

Glycerin (ORGANIC), Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Flower Extract,

Melia Azadirachta Leaf Extract, Neopentyl Glycol Diheptanoate, Ocimum Basilicum (Basil) Flower/Leaf Extract,

Ocimum Sanctum Leaf Extract, Parfum, Polyacrylate Crosspolymer-6, Propanediol, Schinus Molle Extract, Silica,

Sodium Hydroxide, Sodium Phytate, Sodium Polyacrylate, Sodium Melongena (Eggplant) Fruit Extract, Sorbitan

Oleate, Sorbitan Palmitate, Tetrahexyldecyl Ascorbate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone, Water

Section 53413-1

Questions or comments? Call 760-940-2125

Section 55105-1

Purpose .........Suncreen

Section 55106-9

Drug Facts

Active Ingredients

Avobenzone 2.0%, Homosalate 2.0%, Octisalate 3.0%, Octocrylene 5.0%

Section 60561-8

Other information • protect this product from excessive heat and direct sun

Coola Label

SPF

30

70%+ Organic

COOLA​®

Day SPF 30 & Night

Eye Cream Duo

Full 360° Spectrum

With Vitamin C & Resveratrol

Stress from Blue Light, Pollution & Fatigue

Broad Spectrum SPF 30

0.8 FL OZ / 24 mL

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

Cool San Diego, CA 92010.  All Rights Reserved.  www.coola.com

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

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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 caused by the sun

Dosage and Administration (34068-7)

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 spection 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

Warnings and Precautions (34071-1)

Warnings

For external use onlyDo 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 product is swallowed, get medical help or contact

a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients 1,2-HEXANEDIOL, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice

(ORGANIC), Amino Esters-1(JPN), Butylene Glycol, C12-15 Alkyl Benzoate, Caprylyl Glycol, Carthamus Tinctorius

(Safflower) Oleosomes, Cetearyl Alcohol , Cetyl Palmitate, Coccinia Indica Fruit Extract, Corallina Officinalis Extract,

Corallina Officinalis Powder, Curcuma Longa (Turmeric) Root Extract, Dimethicone, Dimethicone Crosspolymer,

Glycerin (ORGANIC), Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Flower Extract,

Melia Azadirachta Leaf Extract, Neopentyl Glycol Diheptanoate, Ocimum Basilicum (Basil) Flower/Leaf Extract,

Ocimum Sanctum Leaf Extract, Parfum, Polyacrylate Crosspolymer-6, Propanediol, Schinus Molle Extract, Silica,

Sodium Hydroxide, Sodium Phytate, Sodium Polyacrylate, Sodium Melongena (Eggplant) Fruit Extract, Sorbitan

Oleate, Sorbitan Palmitate, Tetrahexyldecyl Ascorbate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone, Water

Section 53413-1 (53413-1)

Questions or comments? Call 760-940-2125

Section 55105-1 (55105-1)

Purpose .........Suncreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Avobenzone 2.0%, Homosalate 2.0%, Octisalate 3.0%, Octocrylene 5.0%

Section 60561-8 (60561-8)

Other information • protect this product from excessive heat and direct sun

Coola Label (COOLA Label)

SPF

30

70%+ Organic

COOLA​®

Day SPF 30 & Night

Eye Cream Duo

Full 360° Spectrum

With Vitamin C & Resveratrol

Stress from Blue Light, Pollution & Fatigue

Broad Spectrum SPF 30

0.8 FL OZ / 24 mL

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

Cool San Diego, CA 92010.  All Rights Reserved.  www.coola.com

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

res


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