Coola Refreshing Water Mist Sunscreen Spf 30

Coola Refreshing Water Mist Sunscreen Spf 30
SPL v1
SPL
SPL Set ID 99d86e48-3c0e-4dec-e053-2995a90a7d05
Route
TOPICAL
Published
Effective Date 2018-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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

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

* 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 risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and othersunprotection 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 43685-7

Warnings



For external use only

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 lsononanoate, 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)

* 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 risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and othersunprotection 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

Section 43685-7 (43685-7)

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), Butylene Glycol, Caprylyl Glycol, Ceteareth-12, Ceteareth-20, Cetearyl Alcohol, Cetearyl lsononanoate, 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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