Beautipharm Eye Care Balm - FDA Label NDC 6889-0319

The following Structured Product Label (SPL) was submitted to the FDA by Linde Eckstein Gmbh + Co. Kg for the product Beautipharm Eye Care Balm (NDC 6889-0319). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding beautipharm® eye care balm, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Beautipharm® Eye Care Balm

Labelling Box 06116 (Fs Eye Care Balm 061016)

SPF 10

1 OZ. NET.WT. – 30 ml

Art. 03190

MADE IN GERMANY

Augencreme - Eye Cream – Oogcrème – Crema occhi – Crema Para Ojos

Ingredients: Aqua (Water), Ethylhexyl Methoxycinnamate, Octocrylene, Caprylic/Capric Triglyceride, Polysorbate 60, Theobroma Cacao (Cocoa) Seed Butter, Sorbitan Stearate, Steareth-7, Stearyl Alcohol, Glycerin, Benzyl Alcohol, Cetyl Hydroxyethylcellulose, Opuntia Ficus-Indica (Cactus) Flower Extract, Sodium Carbomer, Bisabolol, Tocopheryl Acetate, Vaccinium Myrtillus (Bilberry) Fruit Extract, Sodium Hyaluronate, Dehydroacetic Acid, Diazolidinyl Urea, Saccharum Officinarum (Sugar Cane) Extract, Allantoin, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Lactic Acid, Retinyl Palmitate, Acer Saccharum (Sugar Maple) Extract, Potassium Sorbate, Sodium Benzoate.

NL-Cosinta, Bleiswijk

KosmEck Italia – Bosisio Parini (LC)

CH-Intercosina AG, Aarberg

Eckstein Biokosmetik USA

Carlsbad, CA 92010

LINDE ECKSTEIN GMBH+CO.KG

90522 OBERASBACH · GERMANY

Drug Facts

Active Ingredients

Octocrylene 4%

Octyl methoxycinnamate 4%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

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 a doctor if rash occurs

• Keep out of reach of children

• If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure

• Reapply:

• after 40 minutes of 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 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

Inactive ingredients

Acer Saccharum (Sugar Maple) Extract, Allantoin, Aqua (Water), Benzyl Alcohol, Bisabolol, Caprylic/Capric Triglyceride, Cetyl Hydroxyethylcellulose, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Dehydroacetic Acid, Diazolidinyl Urea, Glycerin, Lactic Acid, Opuntia Ficus-Indica (Cactus) Flower Extract, Polysorbate 60, Potassium Sorbate, Retinyl Palmitate, Saccharum Officinarum (Sugar Cane) Extract, Sodium Benzoate, Sodium Carbomer, Sodium Hyaluronate, Sorbitan Stearate, Steareth-7, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Vaccinium Myrtillus (Bilberry) Fruit Extract.

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free +888 345 1950

Labelling Bottle 071016 (Gf Eye Care Balm 071016)

SPF10

1 OZ.NET.WT.– 30 ml