BEAUTIPHARM EYE CARE BALM SPF 10- sunscreen cream 
Linde Eckstein GmbH + Co. KG

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Beautipharm® Eye Care Balm

Beautipharm® Eye Care Balm

Labelling Box 06116

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

Beautipharm® Eye Care Balm

Labelling Bottle 071016

SPF10

1 OZ.NET.WT.– 30 ml

Art. 03190

MADE IN GERMANY

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

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

BEAUTIPHARM EYE CARE BALM  SPF 10
sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:6889-0319
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.33 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.33 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 9.335 g  in 30 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 3.33 g  in 30 mL
POLYSORBATE 60 (UNII: CAL22UVI4M) 3.33 g  in 30 mL
COCOA BUTTER (UNII: 512OYT1CRR) 3.33 g  in 30 mL
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) 3.33 g  in 30 mL
STEARETH-7 (UNII: 820H8P0BYX) 1 g  in 30 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 1 g  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 g  in 30 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) 0.3 g  in 30 mL
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT) 0.3 g  in 30 mL
OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA) 0.3 g  in 30 mL
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.16 g  in 30 mL
LEVOMENOL (UNII: 24WE03BX2T) 0.1 g  in 30 mL
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.1 g  in 30 mL
BILBERRY (UNII: 9P2U39H18W) 0.1 g  in 30 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.1 g  in 30 mL
DEHYDROACETIC ACID (UNII: 2KAG279R6R) 0.09 g  in 30 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 0.03 g  in 30 mL
SUGARCANE (UNII: 81H2R5AOH3) 0.03 g  in 30 mL
ALLANTOIN (UNII: 344S277G0Z) 0.03 g  in 30 mL
ORANGE (UNII: 5EVU04N5QU) 0.01 g  in 30 mL
LEMON (UNII: 24RS0A988O) 0.01 g  in 30 mL
LACTIC ACID (UNII: 33X04XA5AT) 0.01 g  in 30 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.01 g  in 30 mL
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC) 0.003 g  in 30 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.001 g  in 30 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.001 g  in 30 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:6889-0319-021 in 1 BOX11/24/2016
1NDC:6889-0319-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/30/2014
Labeler - Linde Eckstein GmbH + Co. KG (316104744)
Registrant - Linde Eckstein GmbH + Co. KG (316104744)
Establishment
NameAddressID/FEIBusiness Operations
Linde Eckstein GmbH + Co. KG316104744manufacture(6889-0319)

Revised: 10/2016
Document Id: ac6690d1-8064-4b48-b448-8dc3ad06cf4a
Set id: e3f96cc8-c6fc-4761-b230-e79f19397698
Version: 2
Effective Time: 20161005
 
Linde Eckstein GmbH + Co. KG