Coola Classic Body Sunscreen Fragrance-free Spf 50

Coola Classic Body Sunscreen Fragrance-free Spf 50
SPL v6
SPL
SPL Set ID 57f2fdeb-2abc-4ad3-bb89-5faee883c0e5
Route
TOPICAL
Published
Effective Date 2020-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1.75 g) Homosalate (5.0 g) Octisalate (2.0 g) Octocrylene
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 Decyl Glucoside Dimethicone Glycerin 1,2-hexanediol 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 Sodium Hydroxide Disodium Phthalate Sorbitan Monooleate Sorbitan Monopalmitate Tropolone Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-06
Description

DRUG FACTS

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, Decyl Glucoside, Dimethicone, Glycerin

(ORGANIC), 1,2-Hexanediol, 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

Hydroxide, 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 5.0%

Octisalate 2.0%         Octocrylene 5.0%

Section 60561-8

Other Information

  • protect this product from excessive heat and direct sun
Package Label

                                      SPF

                                        50

                                     70% +

                                     Organic

                                     COOLA®

                                      Classic

                                Body Sunscreen

                                 Fragrance-Free

                                Ultra Lightweight

                            Hydrates & Nourishes

                              +Plant Protection®

                             Broad Spectrum SPF 50

                        Water Resistant (80 Minutes)

                              5 FL OZ / 148 mL

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

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.

                              www.coola.com

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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

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, Decyl Glucoside, Dimethicone, Glycerin

(ORGANIC), 1,2-Hexanediol, 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

Hydroxide, 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 5.0%

Octisalate 2.0%         Octocrylene 5.0%

Section 60561-8 (60561-8)

Other Information

  • protect this product from excessive heat and direct sun
Package Label

                                      SPF

                                        50

                                     70% +

                                     Organic

                                     COOLA®

                                      Classic

                                Body Sunscreen

                                 Fragrance-Free

                                Ultra Lightweight

                            Hydrates & Nourishes

                              +Plant Protection®

                             Broad Spectrum SPF 50

                        Water Resistant (80 Minutes)

                              5 FL OZ / 148 mL

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

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.

                              www.coola.com

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Tube

res

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Source: dailymed · Ingested: 2026-02-15T12:02:33.445422 · Updated: 2026-03-14T23:02:10.811423