Coola Refreshing Water Mist Sunscreen Spf 30

Coola Refreshing Water Mist Sunscreen Spf 30
SPL v2
SPL
SPL Set ID 998b6c00-1211-37b9-e053-2a95a90abed5
Route
TOPICAL
Published
Effective Date 2019-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Octisalate (50 mg) Homosalate (100 mg) Octocrylene (55 mg)
Inactive Ingredients
Water Jasminum Sambac Flower Soybean Glyceryl Stearate Se Ceteareth-12 Benzoic Acid Alcohol Aloe Vera Leaf Phytate Sodium Glycerin Medium-chain Triglycerides 1,2-hexanediol Tropolone Hyaluronate Sodium Butylene Glycol Caprylyl Glycol Cocoa Sodium Stearoyl Glutamate Schinus Molle Fruiting Top Ethyl Olivate Coconut Water Cetostearyl Alcohol Propanediol Lauryl Glucoside Cetearyl Isononanoate Cetyl Palmitate Polyoxyl 20 Cetostearyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-12-31

Description

Active ingredients Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.5%


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if skin rash occurs

Keep out of reach of children. If prodcut is swallowed, get medical help or contact Poison Control Center right away.

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

* shake well * apply liberally 15 minutes before sun exposure

* reapply: * after 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 rise, 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 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.5%

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), Butylene Glycol, Caprylyl Glycol, Ceteareth-12, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Citronellyl Acetate, Cocos Nucifera (ORGANIC Coconut) Water, Cyclamen Aldehyde, Ethylene Brassylate, Glycerin (ORGANIC), Glyceryl Stearate, Glycine Soja (Soybean) Extract, Hyaluronic Acid, Jasminum Sambac Leaf Cell Extract, Lauryl Glucoside, Methyl Dihydrojasmonate, Methylenedioxyphenyl Methylpropanal, Olive Oil Polyglyceryl-6 Esters, 1,2-Hexanediol, Propanediol, Schinus Molle Extract, Sodium Phytate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone

Section 51945-4

Section 53413-1

Questions or comments? Call 760-940-2125

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredients

Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.5%

Section 60561-8

Other information

* protect this product from excessive heat and direct sun


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

* shake well * apply liberally 15 minutes before sun exposure

* reapply: * after 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 rise, 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

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if skin rash occurs

Keep out of reach of children. If prodcut is swallowed, get medical help or contact Poison Control Center right away.

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), Butylene Glycol, Caprylyl Glycol, Ceteareth-12, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Citronellyl Acetate, Cocos Nucifera (ORGANIC Coconut) Water, Cyclamen Aldehyde, Ethylene Brassylate, Glycerin (ORGANIC), Glyceryl Stearate, Glycine Soja (Soybean) Extract, Hyaluronic Acid, Jasminum Sambac Leaf Cell Extract, Lauryl Glucoside, Methyl Dihydrojasmonate, Methylenedioxyphenyl Methylpropanal, Olive Oil Polyglyceryl-6 Esters, 1,2-Hexanediol, Propanediol, Schinus Molle Extract, Sodium Phytate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone

Section 51945-4 (51945-4)

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 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.5%

Section 60561-8 (60561-8)

Other information

* protect this product from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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