Coola Classic Body Sunscreen Pina Colada Broad Spectrum Spf 30

Drug Facts

Composition & Product

Active Ingredients

Avobenzone (1.75 g) Homosalate (2.5 g) Octisalate (1.5 g) Octocrylene (3.75 g)

Inactive Ingredients

Aloe Vera Leaf Brassica Rapa Subsp. Oleifera Oil Butylene Glycol Camelina Sativa Seed Oil Caprylyl Glycol Carthamus Tinctorius Seed Oleosomes Safflower Oil Cetostearyl Alcohol Cetyl Palmitate Citric Acid Monohydrate Decyl Glucoside Dimethicone Glycerin 1,2-hexanediol Hydrolyzed Jojoba Esters (acid Form) Jojoba Oil, Randomized Meadowfoam Seed Oil Mauritia Flexuosa Fruit Oil Methyl Dihydroabietate Opuntia Ficus-indica Whole Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Raspberry Seed Oil Silicon Dioxide Disodium Phthalate Sorbitan Monooleate Sorbitan Monopalmitate Tropolone Water Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-11-06

Medication Information

Warnings and Precautions

Warnings

For external use only.

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

spectrum SPF of 15 or higher and after 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

Section 42229-5

DRUG FACTS

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 rash occurs.

Section 50567-7

When using this product keep out of eyes.

Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Brassica

Campestris (Rapeseed) Seed Oil, Butylene Glycol,

Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus

Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius

(Safflower) Seed Oil (ORGANIC), Cetearyl Alcohol, Cetyl

Palmitate, Citric Acid, Decyl Glucoside, Dimethicone,

Flavor*, Glycerin (ORGANIC), 1,2-Hexanediol, Hydrolyzed

Jojoba Esters, Jojoba Esters, Limnanthes Alba

(Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit

Oil, Methyl Dihydroabietate, Opuntia Ficus-Indica Flower

Extract, Polyacrylate Crosspolymer-6, Polysilicone-11,

Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium

Phytate, Sorbitan Oleate, Sorbitan Palmitate, Tropolone,

Water, Xanthan Gum

Section 53413-1

Questions or Comments? Call 760-940-2125

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients

Avobenzone 1.75% Homosalate 2.5%

Octisalate 1.5% Octocrylene 3.75%

Section 60561-8

Other Information

protect this product from excessive heat and direct sun

Package Label

SPF

30

70% +

Organic

COOLA^®

Classic

Body Sunscreen

Pina Colada

   Ultra Lightweight

                           Hydrates & Nourishes

                             +Plant Protection^®

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

5 FL OZ / 148 mL

Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

*Naturally derived. See coola.com for additional detail.

2020 COOLA. Distributed by: COOLA LLC, located in Sunny

& Cool San Diego, CA 92010. BIORUS / EU: 7170 Manage,

Belgium / UK: London WC2H 9JQ. All Rights Reserved.

Questions or Comments? Call 760-940-2125

www.coola.com

Box

Tube

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 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

spectrum SPF of 15 or higher and after 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.

Section 42229-5 (42229-5)

DRUG FACTS

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 rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes.

Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Brassica

Campestris (Rapeseed) Seed Oil, Butylene Glycol,

Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus

Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius

(Safflower) Seed Oil (ORGANIC), Cetearyl Alcohol, Cetyl

Palmitate, Citric Acid, Decyl Glucoside, Dimethicone,

Flavor*, Glycerin (ORGANIC), 1,2-Hexanediol, Hydrolyzed

Jojoba Esters, Jojoba Esters, Limnanthes Alba

(Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit

Oil, Methyl Dihydroabietate, Opuntia Ficus-Indica Flower

Extract, Polyacrylate Crosspolymer-6, Polysilicone-11,

Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium

Phytate, Sorbitan Oleate, Sorbitan Palmitate, Tropolone,

Water, Xanthan Gum

Section 53413-1 (53413-1)

Questions or Comments? Call 760-940-2125

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Avobenzone 1.75% Homosalate 2.5%

Octisalate 1.5% Octocrylene 3.75%

Section 60561-8 (60561-8)

Other Information

protect this product from excessive heat and direct sun

Package Label

SPF

30

70% +

Organic

COOLA^®

Classic

Body Sunscreen

Pina Colada

   Ultra Lightweight

                           Hydrates & Nourishes

                             +Plant Protection^®

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

5 FL OZ / 148 mL

Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

*Naturally derived. See coola.com for additional detail.

2020 COOLA. Distributed by: COOLA LLC, located in Sunny

& Cool San Diego, CA 92010. BIORUS / EU: 7170 Manage,

Belgium / UK: London WC2H 9JQ. All Rights Reserved.

Questions or Comments? Call 760-940-2125

www.coola.com

Box

Tube

res

Advanced Ingredient Data

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"strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROLYZED JOJOBA ESTERS (ACID FORM)", "unii": "UDR641JW8W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL, RANDOMIZED", "unii": "7F0EV20QYL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEADOWFOAM SEED OIL", "unii": "412ZHA4T4Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": 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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 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 spectrum SPF of 15 or higher and after 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.", "42229-5": "DRUG FACTS", "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 rash occurs.", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin.", "51727-6": "Inactive Ingredients Aloe Barbadensis Leaf Juice (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Butylene Glycol, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Cetearyl Alcohol, Cetyl Palmitate, Citric Acid, Decyl Glucoside, Dimethicone, Flavor*, Glycerin (ORGANIC), 1,2-Hexanediol, Hydrolyzed Jojoba Esters, Jojoba Esters, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Methyl Dihydroabietate, Opuntia Ficus-Indica Flower Extract, Polyacrylate Crosspolymer-6, Polysilicone-11, Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium Phytate, Sorbitan Oleate, Sorbitan Palmitate, Tropolone, Water, Xanthan Gum", "53413-1": "Questions or Comments? Call 760-940-2125", "55105-1": "Purpose Sunscreen", "55106-9": "Active Ingredients Avobenzone 1.75% Homosalate 2.5% Octisalate 1.5% Octocrylene 3.75%", "60561-8": "Other Information protect this product from excessive heat and direct sun", "Package Label": " SPF 30 70% + Organic COOLA ® Classic Body Sunscreen Pina Colada Ultra Lightweight Hydrates & Nourishes +Plant Protection ® Broad Spectrum SPF 30 Water Resistant (80 Minutes) 5 FL OZ / 148 mL Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free *Naturally derived. See coola.com for additional detail. 2020 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010. BIORUS / EU: 7170 Manage, Belgium / UK: London WC2H 9JQ. All Rights Reserved. Questions or Comments? Call 760-940-2125 www.coola.com Box Tube res"}

Coola Classic Body Sunscreen Pina Colada Broad Spectrum Spf 30

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information