Coola Liplux Hydrating Oil Spf 30

Coola Liplux Hydrating Oil Spf 30
SPL v2
SPL
SPL Set ID 2d2ad94c-ea13-43c0-ab7f-acecf4d2309f
Route
TOPICAL
Published
Effective Date 2021-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 g) Homosalate (4.0 g) Octisalate (10.0 g) Octocrylene
Inactive Ingredients
Adipic Acid/diglycol Crosspolymer (20000 Mpa.s) Camellia Oil Caprylic/capric/lauric Triglyceride Ethylhexyl Methoxycrylene Glyceryl Caprylate Sunflower Oil Polyglyceryl-3 Diisostearate Medium-chain Triglycerides Punica Granatum Flower Jojoba Oil Saccharin Sodium .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-22

Description

Drug Facts Active Ingredients Avobenzone 3.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 10.0%


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.

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 & again after swimming or sweating. Apply at least every 2 hours.

Sun Protection Measures - To decrease your risk of cancer and early skin aging. 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. and wear

long-sleeve shirts, pants, hats, and sunglasses.  Children under 6 months: Ask a doctor

Description

Drug Facts Active Ingredients Avobenzone 3.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 10.0%

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 51727-6

Inactive Ingredients- ​Adipic Acid/Diglycol Crosspolymer,Camellia Oleifera Seed Oil (ORGANIC),Caprylic/Capric Triglyceride,Ethylhexylmethoxycrylene,Flavor,Glyceryl Caprylate,Helianthus Annus (Sunflower) Seed Oil (ORGANIC),Polyglyceryl-3 Diisostearate,Polyurethane-79,Punica Granatum Flower Extract,Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC),Sodium Saccharin,Tocopheryl Acetate

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 4.0%, Octisalate 4.0%, Octocrylene 10.0%

Section 60561-8

Other information

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

SPF

30

70%+

Organic

COOLA​®

Liplux®

Hydrating Oil

​Golden Glow

Nourishes & Protects ​​

Broad Spectrum SPF 30

0.11 FL OZ / 3.2 mL

©2021 COOLA. Distributed by: COOLA LLC, located in

Sunny & Cool San Diego, CA 92010.

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 - Apply liberally 15 minutes before sun exposure & again after swimming or sweating. Apply at least every 2 hours.

Sun Protection Measures - To decrease your risk of cancer and early skin aging. 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. and 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.

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 51727-6 (51727-6)

Inactive Ingredients- ​Adipic Acid/Diglycol Crosspolymer,Camellia Oleifera Seed Oil (ORGANIC),Caprylic/Capric Triglyceride,Ethylhexylmethoxycrylene,Flavor,Glyceryl Caprylate,Helianthus Annus (Sunflower) Seed Oil (ORGANIC),Polyglyceryl-3 Diisostearate,Polyurethane-79,Punica Granatum Flower Extract,Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC),Sodium Saccharin,Tocopheryl Acetate

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 4.0%, Octisalate 4.0%, Octocrylene 10.0%

Section 60561-8 (60561-8)

Other information

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

SPF

30

70%+

Organic

COOLA​®

Liplux®

Hydrating Oil

​Golden Glow

Nourishes & Protects ​​

Broad Spectrum SPF 30

0.11 FL OZ / 3.2 mL

©2021 COOLA. Distributed by: COOLA LLC, located in

Sunny & Cool San Diego, CA 92010.

Carton

Bottle

res


Advanced Ingredient Data


Raw Label Data

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