Coola Classic Body Sunscreen Guava Mango Broad Spectrum Spf 50

Coola Classic Body Sunscreen Guava Mango Broad Spectrum Spf 50
SPL v3
SPL
SPL Set ID 9a397a2c-4734-4dae-93dd-15c68e6c297d
Route
TOPICAL
Published
Effective Date 2023-04-05
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 Flower 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 Phytate Sodium Sorbitan Monooleate Sorbitan Monopalmitate Tropolone Water Xanthan Gum

Identifiers & Packaging

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

Flavor*, 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
  • may stain fabrics
Package Label

                                      SPF

                                       50

                                      70% +

                                     Organic

                                     COOLA

                                     Classic

                                Body Sunscreen

                                  Guava Mango

                                Ultra Lightweight

                             Hydrates & Nourishes

                              +Plant Protection®

                          Broad Spectrum SPF 50

                      Water Resistant (80 Minutes)

                             3.4 FL OZ / 100 mL

2020 COOLA. Distributed by: COOLA LLC,

located in Sunny& Cool San Diego, CA 92009.

All Rights Reserved. ww.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, Decyl Glucoside, Dimethicone,

Flavor*, 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
  • may stain fabrics
Package Label

                                      SPF

                                       50

                                      70% +

                                     Organic

                                     COOLA

                                     Classic

                                Body Sunscreen

                                  Guava Mango

                                Ultra Lightweight

                             Hydrates & Nourishes

                              +Plant Protection®

                          Broad Spectrum SPF 50

                      Water Resistant (80 Minutes)

                             3.4 FL OZ / 100 mL

2020 COOLA. Distributed by: COOLA LLC,

located in Sunny& Cool San Diego, CA 92009.

All Rights Reserved. ww.coola.com

Box

Tube

res

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Source: dailymed · Ingested: 2026-02-15T12:05:05.899918 · Updated: 2026-03-14T23:06:25.914429