Coola Classic Face Sunscreen Fragrance-free Spf 50

Drug Facts

Composition & Product

Active Ingredients

Octisalate (20 mg) Octocrylene (50 mg) Homosalate (17.5 mg) Avobenzone

Inactive Ingredients

Sodium Hydroxide Xanthan Gum Water Tropolone Phytate Sodium Aloe Vera Leaf Decyl Glucoside Citric Acid Monohydrate Butylene Glycol 1,2-hexanediol Squalane Brassica Rapa Subsp. Oleifera Oil Cetostearyl Alcohol Sorbitan Monopalmitate Sorbitan Monooleate Methyl Dihydroabietate Sodium Benzoate Raspberry Seed Oil Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Silicon Dioxide Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Opuntia Ficus-indica Gluconolactone Carthamus Tinctorius Seedcake Dimethicone Meadowfoam Seed Oil Glycerin Safflower Oil Caprylyl Glycol Camelina Sativa Seed Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-02-01

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 rise 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 aging. To decrease this risk, regularly use a sunscreen with a broad spectrum 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-sleve shirts, pants, hats, and sunglasses

* children under 6 months: Ask a doctor

Description

Active Ingredients AVOBENZONE 1.75%, HOMOSALATE 5.0%, OCTISALATE 2.0%, 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 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),

Carthamus Tinctorius (Safflower) Oleosomes,

Water, Carthamus Tinctorius (Safflower) Seed Oil

(ORGANIC), Glycerin (ORGANIC), Polyacrylate

Crosspolymer-6, Limnanthes Alba

(Meadowfoam) Seed Oil, Mauritia Flexuosa

(Buriti) Fruit Oil, Rubus Idaeus (Raspberry) Seed

Oil, Squalane, Brassica Campestris (Rapeseed)

Seed Oil, Opuntia Ficus-Indica Flower Extract,

Camelina Sativa Seed Oil, Tropolone, Cetyl

Palmitate, Sodium Hydroxide, Citric Acid,

Cetearyl Alcohol, Caprylyl Glycol,

1,2-Hexanediol, Sorbitan Palmitate, Methyl

Dihydroabietate, Xanthan Gum, Dimethicone,

Sorbitan Oleate, Gluconolactone, Silica, Sodium

Phytate, Sodium Benzoate, Polysilicone-11,

Butylene Glycol, Decyl Glucoside

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

Product Labeling Coola Classic Face Sunscreen Fragrance Free Spf 50

SPF

50

70% +

Organic

COOLA

Classic

Face Sunscreen

FragranceiFree

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

1.7 FL OZ / 50 mL

2022 COOLA. Manufactured in the USA forDistributed by: COOLA LLC,

COOLA LLC, located in Sunny& Cool San Diego,

Carton

Tube

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 rise 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 aging. To decrease this risk, regularly use a sunscreen with a broad spectrum 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-sleve shirts, pants, hats, and sunglasses

* children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

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 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),

Carthamus Tinctorius (Safflower) Oleosomes,

Water, Carthamus Tinctorius (Safflower) Seed Oil

(ORGANIC), Glycerin (ORGANIC), Polyacrylate

Crosspolymer-6, Limnanthes Alba

(Meadowfoam) Seed Oil, Mauritia Flexuosa

(Buriti) Fruit Oil, Rubus Idaeus (Raspberry) Seed

Oil, Squalane, Brassica Campestris (Rapeseed)

Seed Oil, Opuntia Ficus-Indica Flower Extract,

Camelina Sativa Seed Oil, Tropolone, Cetyl

Palmitate, Sodium Hydroxide, Citric Acid,

Cetearyl Alcohol, Caprylyl Glycol,

1,2-Hexanediol, Sorbitan Palmitate, Methyl

Dihydroabietate, Xanthan Gum, Dimethicone,

Sorbitan Oleate, Gluconolactone, Silica, Sodium

Phytate, Sodium Benzoate, Polysilicone-11,

Butylene Glycol, Decyl Glucoside

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

Product Labeling Coola Classic Face Sunscreen Fragrance Free Spf 50 (Product Labeling - COOLA Classic Face Sunscreen Fragrance-Free SPF 50)

SPF

50

70% +

Organic

COOLA

Classic

Face Sunscreen

FragranceiFree

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

1.7 FL OZ / 50 mL

2022 COOLA. Manufactured in the USA forDistributed by: COOLA LLC,

COOLA LLC, located in Sunny& Cool San Diego,

Carton

Tube

Advanced Ingredient Data

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OLEIFERA OIL", "unii": "N4G8379626", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN MONOPALMITATE", "unii": "77K6Z421KU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN MONOOLEATE", "unii": "06XEA2VD56", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL DIHYDROABIETATE", "unii": "7666FJ0J9F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "RASPBERRY SEED OIL", "unii": "9S8867952A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)", "unii": "9E4CO0W6C5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)", "unii": "Q7UI015FF9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OPUNTIA FICUS-INDICA", "unii": "23Z87HTQ6P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLUCONOLACTONE", "unii": "WQ29KQ9POT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARTHAMUS TINCTORIUS SEEDCAKE", "unii": "DHQ13F4N2W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEADOWFOAM SEED OIL", "unii": "412ZHA4T4Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SAFFLOWER OIL", "unii": "65UEH262IS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMELINA SATIVA SEED OIL", "unii": "12824X01L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "17.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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 rise 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 aging. To decrease this risk, regularly use a sunscreen with a broad spectrum 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-sleve shirts, pants, hats, and sunglasses * children under 6 months: Ask a doctor", "34071-1": "Warnings For external use only", "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", "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), Carthamus Tinctorius (Safflower) Oleosomes, Water, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Glycerin (ORGANIC), Polyacrylate Crosspolymer-6, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Rubus Idaeus (Raspberry) Seed Oil, Squalane, Brassica Campestris (Rapeseed) Seed Oil, Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Tropolone, Cetyl Palmitate, Sodium Hydroxide, Citric Acid, Cetearyl Alcohol, Caprylyl Glycol, 1,2-Hexanediol, Sorbitan Palmitate, Methyl Dihydroabietate, Xanthan Gum, Dimethicone, Sorbitan Oleate, Gluconolactone, Silica, Sodium Phytate, Sodium Benzoate, Polysilicone-11, Butylene Glycol, Decyl Glucoside", "53413-1": "Questions or comments? Call 760-940-2125", "55105-1": "Purpose Sunscreen", "55106-9": "Active Ingredients AVOBENZONE 1.75%, HOMOSALATE 5.0%, OCTISALATE 2.0%, OCTOCRYLENE 5.0%", "60561-8": "Other Information * protect this product from excessive heat and direct sun * may stain fabrics", "Product Labeling - COOLA Classic Face Sunscreen Fragrance-Free SPF 50": "SPF 50 70% + Organic COOLA Classic Face Sunscreen FragranceiFree Broad Spectrum SPF 50 Water Resistant (80 Minutes) 1.7 FL OZ / 50 mL 2022 COOLA. Manufactured in the USA forDistributed by: COOLA LLC, COOLA LLC, located in Sunny& Cool San Diego, CA 92009. All Rights Reserved. ww.coola.com Carton Tube"}

Coola Classic Face Sunscreen Fragrance-free Spf 50

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information