Coola Dew Good Illuminating Serum Probiotic Sunscreen Spf 30

Coola Dew Good Illuminating Serum Probiotic Sunscreen Spf 30
SPL v1
SPL
SPL Set ID cc7ae92d-613d-47a7-929f-d3d1dc3558b5
Route
TOPICAL
Published
Effective Date 2021-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 g) Octisalate (4.0 mg) Octocrylene (8.0 mg)
Inactive Ingredients
Aloe Vera Leaf Butyloctyl Salicylate Glycerin Ammonium Acryloyldimethyltaurate/vp Copolymer Bismuth Oxychloride Lactobacillus Fermentum Jasminum Sambac Flower Cocoa Schinus Molle Fruiting Top Water Titanium Dioxide Ethyl Ferulate Tropolone Mica Hydroxyacetophenone Propanediol Butylene Glycol Sodium Stearoyl Glutamate 1,2-hexanediol Caprylyl Glycol Ethylhexyl Hydroxystearate Maltodextrin Phytate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-02-01

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

• 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 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, Butolyctyl Salicylate,

Glycerin, Ammonium Acryloldimethyltaurate/VP

Copolymer, Bismuth Oxychloride, Lactobacillus

Ferment, Jasmine Sambach (Jasmine) Leaf Cell

Extract, Theodora Cacao (Cocoa) Seed Extract,

Schinus Molle Extract, Water, Titanium Dioxide, Ethyl

Ferulate, Tropolone, Mica, Hydroxyacetophenone,

Propanediol, Butylene Glycol, Sodium Stearoyl,

Glutamats, 1,2-Hexanediol, Caprylyl Glycol,

Ethylhexyl Hydroxystearate, Maltodextrin, Sodium

Phylate, Fragrance (Natural)

Section 53413-1

Questions or Comments? Call 760-940-2125

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients

Avobenzone 3.0%, Octisalate 4.0%, Octocrylene 8.0%

Section 60561-8

Other Information

  • protect this product from excessive heat and direct sun
Coola Dew Good Package Label

SPF

30

70%

Organic

COOLA®

Dew Good

Illuminating Serum

Probiotic Sunscreen

1.15 FL OZ / 35 mL

Distributed by: COOLA LLC,

Locate at 6023 Innovation Way in

Sunny and Cool San Diego, CA 92009

www.coola.com

Carton

Bottle

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

• 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 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, Butolyctyl Salicylate,

Glycerin, Ammonium Acryloldimethyltaurate/VP

Copolymer, Bismuth Oxychloride, Lactobacillus

Ferment, Jasmine Sambach (Jasmine) Leaf Cell

Extract, Theodora Cacao (Cocoa) Seed Extract,

Schinus Molle Extract, Water, Titanium Dioxide, Ethyl

Ferulate, Tropolone, Mica, Hydroxyacetophenone,

Propanediol, Butylene Glycol, Sodium Stearoyl,

Glutamats, 1,2-Hexanediol, Caprylyl Glycol,

Ethylhexyl Hydroxystearate, Maltodextrin, Sodium

Phylate, Fragrance (Natural)

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 3.0%, Octisalate 4.0%, Octocrylene 8.0%

Section 60561-8 (60561-8)

Other Information

  • protect this product from excessive heat and direct sun
Coola Dew Good Package Label (COOLA Dew Good Package Label)

SPF

30

70%

Organic

COOLA®

Dew Good

Illuminating Serum

Probiotic Sunscreen

1.15 FL OZ / 35 mL

Distributed by: COOLA LLC,

Locate at 6023 Innovation Way in

Sunny and Cool San Diego, CA 92009

www.coola.com

Carton

Bottle

res


Advanced Ingredient Data


Raw Label Data

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