Coola Refreshing Water Plumping Gel Serum Spf 30

Coola Refreshing Water Plumping Gel Serum Spf 30
SPL v1
SPL
SPL Set ID 51d5862a-8f2c-40c6-a749-5ad6f9420143
Route
TOPICAL
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 g) Homosalate (6.0 g) Octisalate (5.0 g) Octocrylene (7.0 g)
Inactive Ingredients
Aloe Vera Leaf Alcohol Ammonium Acryloyldimethyltaurate/vp Copolymer Butyloctyl Salicylate Ethylhexyl Methoxycrylene Hyaluronic Acid Coconut Water Alaria Esculenta Aloe Vera Flower Jasminum Officinale Leaf Azadirachta Indica Leaf Azadirachta Indica Flower Corallina Officinalis Coccinia Grandis Fruit Eggplant Cocoa Turmeric Holy Basil Leaf Ocimum Basilicum Flowering Top Schinus Molle Fruiting Top Medium-chain Triglycerides Water Ethyl Ferulate Propanediol Butylene Glycol 1,2-hexanediol Caprylyl Glycol Triethyl Citrate Starch, Tapioca Glycerin .gamma.-nonalactone Tropolone Juniperus Deppeana Wood Oil .gamma.-octalactone Benzyl Acetate Phenylethyl Alcohol Mimosa Tenuiflora Bark Vanillin Piperonal P-anisaldehyde .delta.-decalactone Methylbenzyl Acetate Ethyl Butyrate Methyl Anthranilate Methyl Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Drug Facts Active Ingredients Avobenzone 3.0%, Homosalate 6.0%, Octisalate 5.0%, Octocrylene 7.0%


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

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 at least every 2 hours

● use a water resistant sunscreen if wimming or sweating

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

spection 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-sleeve shirts, pants, hats, and sunglasses

  ●children under 6 months: Ask a doctor

Description

Drug Facts Active Ingredients Avobenzone 3.0%, Homosalate 6.0%, Octisalate 5.0%, Octocrylene 7.0%

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 51727-6

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Alcohol Denat (ORGANIC),

Ammonium Acryloyldimethyltaurate/VP Copolymer Butyloctyl

Salicylate, Ethylhexyl Methoxycrylene, Hyaluronic Acid, Cocos Nucifera

(Coconut) Fruit Water (ORGANIC), Alaria Esculenta Extract, Aloe

Barbadensis Flower Extract, Jasminum Sambac (Jasmine) Leaf Cell

Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract,

Corallina Officinalis Extract, Coccinia Indica Fruit Extract, Solanum

Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed

Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum

(Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus

Molle Extract, Caprylic/Capric Triglyceride, Water, Ethyl Ferulate,

Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Triethyl

Citrate*, Tapioca Starch, Glycerin, Gamma-Nonalactone*, Tropolone,

Juniperus Mexicana Oil*, Gamma-Octalactone*, Benzyl Acetate*,

Phenylethyl Alcohol*, Mimosa Tenuiflora Bark Extract*, Vanillin*,

Heliotropine*, Anisaldehyde*, Delta-Decalactone*, Methylbenzyl

Acetate*, Ethyl Butyrate*, Methyl Anthranilate*, Methyl Benzoate*

*Plant derived scent constituent. See coola.com for additional detail.

Section 53413-1

Questions or comments? Call 760-940-2125

Section 55105-1

Purpose

Suncreen

Section 55106-9

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 6.0%, Octisalate 5.0%, Octocrylene 7.0%

Section 60561-8

Other information

  • protect this product from excessive heat and direct sun
Coola Refreshing Water Plumping Gel Serum Labeling

COOLA®

Refreshing Water

Plumping Gel Serum

Sunscreen

Broad Spectrum SPF 30

©2024 COOLA

Manufactured in the USA for

COOLA LLC, located in sunny

San Diego, CA 92009.

All Rights Reserved.

www.coola.com



Carton

Bottle

Tube

Sachet

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 at least every 2 hours

● use a water resistant sunscreen if wimming or sweating

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

spection 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-sleeve 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

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 51727-6 (51727-6)

Inactive Ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Alcohol Denat (ORGANIC),

Ammonium Acryloyldimethyltaurate/VP Copolymer Butyloctyl

Salicylate, Ethylhexyl Methoxycrylene, Hyaluronic Acid, Cocos Nucifera

(Coconut) Fruit Water (ORGANIC), Alaria Esculenta Extract, Aloe

Barbadensis Flower Extract, Jasminum Sambac (Jasmine) Leaf Cell

Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract,

Corallina Officinalis Extract, Coccinia Indica Fruit Extract, Solanum

Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed

Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum

(Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus

Molle Extract, Caprylic/Capric Triglyceride, Water, Ethyl Ferulate,

Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Triethyl

Citrate*, Tapioca Starch, Glycerin, Gamma-Nonalactone*, Tropolone,

Juniperus Mexicana Oil*, Gamma-Octalactone*, Benzyl Acetate*,

Phenylethyl Alcohol*, Mimosa Tenuiflora Bark Extract*, Vanillin*,

Heliotropine*, Anisaldehyde*, Delta-Decalactone*, Methylbenzyl

Acetate*, Ethyl Butyrate*, Methyl Anthranilate*, Methyl Benzoate*

*Plant derived scent constituent. See coola.com for additional detail.

Section 53413-1 (53413-1)

Questions or comments? Call 760-940-2125

Section 55105-1 (55105-1)

Purpose

Suncreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 6.0%, Octisalate 5.0%, Octocrylene 7.0%

Section 60561-8 (60561-8)

Other information

  • protect this product from excessive heat and direct sun
Coola Refreshing Water Plumping Gel Serum Labeling (COOLA Refreshing Water Plumping Gel Serum - Labeling)

COOLA®

Refreshing Water

Plumping Gel Serum

Sunscreen

Broad Spectrum SPF 30

©2024 COOLA

Manufactured in the USA for

COOLA LLC, located in sunny

San Diego, CA 92009.

All Rights Reserved.

www.coola.com



Carton

Bottle

Tube

Sachet

res


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