Coola Classic Face Sunscreen Cucumber Broad Spectrum Spf 30

Coola Classic Face Sunscreen Cucumber Broad Spectrum Spf 30
SPL v2
SPL
SPL Set ID dec3b0d1-f06e-4acf-8ba2-64167e774abc
Route
TOPICAL
Published
Effective Date 2023-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 Amyris Balsamifera Oil 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 Citronellyl Acetate Orange Oil Decanal Decyl Glucoside Dimethicone 2,6-dimethyl-5-heptenal Glycerin 1,2-hexanediol 3-hexen-1-ol, (3z)- Hexenyl Acetate, (2z)- Hexyl Acetate Hydrolyzed Jojoba Esters (acid Form) Jojoba Oil, Randomized Meadowfoam Seed Oil Linalyl Acetate Mauritia Flexuosa Fruit Oil Methyl Dihydroabietate Nerol 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 Squalane Triethyl Citrate 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 40 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), Amyris

Balsamifera Bark Oil*, 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,

Citronellyl Acetate*, Citrus Aurantium Dulcis

(Orange) Peel Oil*, Decanal*, Decyl Glucoside,

Dimethicone, Dimethyl Heptenal*, Glycerin

(ORGANIC), 1,2-Hexanediol, 3-Hexenol*,

Hexenyl Acetate*, Hexyl Acetate*, Hydrolyzed

Jojoba Esters, Jojoba Esters, Limnanthes Alba

(Meadowfoam) Seed Oil, Linalyl Acetate*,

Mauritia Flexuosa (Buriti) Fruit Oil, Methyl

Dihydroabietate, Nerol*, Opuntia Ficus-Indica

Flower Extract, Polyacrylate, Crosspolymer-6,

Polysilicone-11, Rubus Idaeus (Raspberry) Seed

Oil, Silica, Sodium Phytate, Sorbitan Oleate,

Sorbitan Palmitate, Squalane, Triethyl Citrate*,

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 Coola Classic Face Sunscreen Cucumber Broad Spectrum Spf 30

  NEEDS OUTER BOX LABELING INSERTED    

                                    SPF

                                       30

                                    70% +

                                    Organic

                                    COOLA®

                                    Classic

                              Face Sunscreen

                                  Cucumbar

                               Non-Greasy

                           Ultralight Hydration

                             +Plant Protection®

                          Broad Spectrum SPF 30

                     Water Resistant (40 Minutes)

                          .85 FL OZ / 25 mL

2021 COOLA. Distributed by: COOLA LLC,

located in Sunny & Cool San Diego, CA 92010. ,

   All Rights Reserved.  www.coola.com

Box TO DELETE OLD!!!!!!

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 40 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), Amyris

Balsamifera Bark Oil*, 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,

Citronellyl Acetate*, Citrus Aurantium Dulcis

(Orange) Peel Oil*, Decanal*, Decyl Glucoside,

Dimethicone, Dimethyl Heptenal*, Glycerin

(ORGANIC), 1,2-Hexanediol, 3-Hexenol*,

Hexenyl Acetate*, Hexyl Acetate*, Hydrolyzed

Jojoba Esters, Jojoba Esters, Limnanthes Alba

(Meadowfoam) Seed Oil, Linalyl Acetate*,

Mauritia Flexuosa (Buriti) Fruit Oil, Methyl

Dihydroabietate, Nerol*, Opuntia Ficus-Indica

Flower Extract, Polyacrylate, Crosspolymer-6,

Polysilicone-11, Rubus Idaeus (Raspberry) Seed

Oil, Silica, Sodium Phytate, Sorbitan Oleate,

Sorbitan Palmitate, Squalane, Triethyl Citrate*,

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 Coola Classic Face Sunscreen Cucumber Broad Spectrum Spf 30 (Package Label - COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30)

  NEEDS OUTER BOX LABELING INSERTED    

                                    SPF

                                       30

                                    70% +

                                    Organic

                                    COOLA®

                                    Classic

                              Face Sunscreen

                                  Cucumbar

                               Non-Greasy

                           Ultralight Hydration

                             +Plant Protection®

                          Broad Spectrum SPF 30

                     Water Resistant (40 Minutes)

                          .85 FL OZ / 25 mL

2021 COOLA. Distributed by: COOLA LLC,

located in Sunny & Cool San Diego, CA 92010. ,

   All Rights Reserved.  www.coola.com

Box TO DELETE OLD!!!!!!

Tube

res

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Source: dailymed · Ingested: 2026-02-15T12:05:06.855470 · Updated: 2026-03-14T23:06:27.679265