Coola Full Spectrum 360 Refreshing Water Cream Spf 50

Drug Facts

Composition & Product

Active Ingredients

Avobenzone (3.0 g) Homosalate (5.0 g) Octisalate Octocrylene

Inactive Ingredients

Adipic Acid/diglycol Crosspolymer (20000 Mpa.s) Aloe Vera Flower Aloe Vera Leaf P-anisaldehyde Argan Oil Benzyl Acetate Levomenol Butylene Glycol Caprylhydroxamic Acid Carthamus Tinctorius (safflower) Oleosomes Citric Acid Monohydrate Coccinia Grandis Leaf Coconut Water Corallina Officinalis Turmeric .delta.-decalactone Ethyl Butyrate .gamma.-nonalactone .gamma.-octalactone Gluconolactone Glycerin Glyceryl Caprylate Glyceryl Monostearate Piperonal Hyaluronic Acid Isododecane Jasminum Sambac Flower Juniperus Deppeana Wood Oil Lecithin, Soybean Leuconostoc/radish Root Ferment Filtrate Azadirachta Indica Flower Azadirachta Indica Leaf Methyl Anthranilate Methyl Benzoate Methylbenzyl Acetate Mimosa Tenuiflora Bark Neopentyl Glycol Diheptanoate Nerolidol Ocimum Basilicum Flowering Top Holy Basil Leaf Phenylethyl Alcohol Propanediol Schinus Molle Fruiting Top Sodium Acrylate/styrene Sulfonate Copolymer (11000 Mw) Sodium Benzoate Sodium Hydroxide Sodium Stearoyl Glutamate Eggplant Cocoa .alpha.-tocopherol Acetate Triethyl Citrate Vanillin Water Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-02-08

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.

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 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 3.0%, Homosalate 5.0%, Octisalate 3.0%, Octocrylene 5.0%

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 51727-6

Inactive Ingredients

Adipic Acid/Diglycol Crosspolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, (ORGANIC)

Anisaldehyde*, Argania Spinosa Kernel Oil, Benzyl Acetate*, Bisabolol, Butylene Glycol, Caprylhydroxamic Acid,

Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Citric Acid, Coccinia Indica Fruit Extract, Cocos Nucifera

(Coconut) Water (ORGANIC), Corallina Officinalis Extract, Curcuma Longa (Turmeric) Root Extract, Delta-Decalactone*,

Ethyl Butyrate*, Gamma-Nonalactone*, Gamma-Octalactone*, Gluconolactone, Glycerin (ORGANIC), Glyceryl Caprylate,

Glyceryl Stearate, Heliotropine*, Hyaluronic Acid, Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Juniperus

Mexicana, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Leuconostoc Ferment Filtrate, Melia Azadirachta Flower

Extract, Melia Azadirachta Leaf Extract, Methyl Anthranilate*, Methyl Benzoate*, Methyl Benzyl Acetate*, Mimosa

Tenuiflora Bark Extract, Neopentyl Glycol Diheptanoate, Nerolidol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum

Sanctum Leaf Extract, Phenethyl Alcohol*, Propanediol, Schinus Molle Extract, Sodium Acrylates Copolymer, Sodium

Benzoate, Sodium Hydroxide, Sodium Stearoyl Glutamate, Solanum Melongena (Eggplant) Fruit Extract, Theobroma

Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Triethyl Citrate*, Vanillin, Water, Xanthan Gum

Section 53413-1

Questions or comments?

Call 760-940-2125

Section 55105-1

Purpose

Suncreen

Section 55106-9

Drug Facts

Active Ingredients

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

Section 60561-8

Other information

protect this product from excessive heat and direct sun

Coola Label

SPF

50

70%+

Organic

COOLA_®

Refreshing Water Cream

Sunscreen

1.5 FL OZ / 44 mL

Broad Spectrum SPF 70

Water Resistant (80 Minutes)

5.0 FL OZ / 148 mL

†Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

*Plant-derived scent constituent. See coola.com for additional detail.

Carton

Bottle

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 caused by the sun

Dosage and Administration (34068-7)

Directions

• 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 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 only

Do not use on damaged or broken skin

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

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 51727-6 (51727-6)

Inactive Ingredients

Adipic Acid/Diglycol Crosspolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, (ORGANIC)

Anisaldehyde*, Argania Spinosa Kernel Oil, Benzyl Acetate*, Bisabolol, Butylene Glycol, Caprylhydroxamic Acid,

Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Citric Acid, Coccinia Indica Fruit Extract, Cocos Nucifera

(Coconut) Water (ORGANIC), Corallina Officinalis Extract, Curcuma Longa (Turmeric) Root Extract, Delta-Decalactone*,

Ethyl Butyrate*, Gamma-Nonalactone*, Gamma-Octalactone*, Gluconolactone, Glycerin (ORGANIC), Glyceryl Caprylate,

Glyceryl Stearate, Heliotropine*, Hyaluronic Acid, Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Juniperus

Mexicana, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Leuconostoc Ferment Filtrate, Melia Azadirachta Flower

Extract, Melia Azadirachta Leaf Extract, Methyl Anthranilate*, Methyl Benzoate*, Methyl Benzyl Acetate*, Mimosa

Tenuiflora Bark Extract, Neopentyl Glycol Diheptanoate, Nerolidol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum

Sanctum Leaf Extract, Phenethyl Alcohol*, Propanediol, Schinus Molle Extract, Sodium Acrylates Copolymer, Sodium

Benzoate, Sodium Hydroxide, Sodium Stearoyl Glutamate, Solanum Melongena (Eggplant) Fruit Extract, Theobroma

Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Triethyl Citrate*, Vanillin, Water, Xanthan Gum

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 3.0%, Homosalate 5.0%, 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

50

70%+

Organic

COOLA_®

Refreshing Water Cream

Sunscreen

1.5 FL OZ / 44 mL

Broad Spectrum SPF 70

Water Resistant (80 Minutes)

5.0 FL OZ / 148 mL

†Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

*Plant-derived scent constituent. See coola.com for additional detail.

Carton

Bottle

res

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "34068-7": "Directions • 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 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", "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.", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask doctor if skin rash occurs", "51727-6": "Inactive Ingredients Adipic Acid/Diglycol Crosspolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, (ORGANIC) Anisaldehyde*, Argania Spinosa Kernel Oil, Benzyl Acetate*, Bisabolol, Butylene Glycol, Caprylhydroxamic Acid, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Citric Acid, Coccinia Indica Fruit Extract, Cocos Nucifera (Coconut) Water (ORGANIC), Corallina Officinalis Extract, Curcuma Longa (Turmeric) Root Extract, Delta-Decalactone*, Ethyl Butyrate*, Gamma-Nonalactone*, Gamma-Octalactone*, Gluconolactone, Glycerin (ORGANIC), Glyceryl Caprylate, Glyceryl Stearate, Heliotropine*, Hyaluronic Acid, Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Juniperus Mexicana, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Leuconostoc Ferment Filtrate, Melia Azadirachta Flower Extract, Melia Azadirachta Leaf Extract, Methyl Anthranilate*, Methyl Benzoate*, Methyl Benzyl Acetate*, Mimosa Tenuiflora Bark Extract, Neopentyl Glycol Diheptanoate, Nerolidol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Phenethyl Alcohol*, Propanediol, Schinus Molle Extract, Sodium Acrylates Copolymer, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Glutamate, Solanum Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Triethyl Citrate*, Vanillin, Water, Xanthan Gum", "53413-1": "Questions or comments? Call 760-940-2125", "55105-1": "Purpose Suncreen", "55106-9": "Drug Facts Active Ingredients Avobenzone 3.0%, Homosalate 5.0%, Octisalate 3.0%, Octocrylene 5.0%", "60561-8": "Other information protect this product from excessive heat and direct sun", "COOLA Label": "SPF 50 70%+ Organic COOLA ® Refreshing Water Cream Sunscreen 1.5 FL OZ / 44 mL Broad Spectrum SPF 70 Water Resistant (80 Minutes) 5.0 FL OZ / 148 mL ©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010. All Rights Reserved. †Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free *Plant-derived scent constituent. See coola.com for additional detail. Carton Bottle res"}

Coola Full Spectrum 360 Refreshing Water Cream Spf 50

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information