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.

Active Ingredient

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 10.0%

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 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

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.

Active Ingredient (55106-9)

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 10.0%

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

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 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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