BEAUTIPHARM ALL DAY MOISTURIZING 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® All Day Moisturizing Balm

Beautipharm® All Day Moisturizing Balm

Labelling Box 061016

SPF 10

1.66 OZ.NET.WT – 50 ml

Art. 03120

MADE IN GERMANY

Gesichtscreme - Facial Cream – Gezichtscrème – Crema viso – Crema Facial

Ingredients: Aqua (Water), Glycerin, Ethylhexyl Methoxycinnamate, Octocrylene, Caprylic/Capric Triglyceride, Decyl Oleate, Theobroma Cacao (Cocoa) Seed Butter, Polysorbate 60, Phenoxyethanol, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Bisabolol, Opuntia Ficus-Indica (Cactus) Flower Extract, Tocopheryl Acetate, Vaccinium Myrtillus (Bilberry) Fruit Extract, Diazolidinyl Urea, Ethylhexylglycerin, 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, Acrylates / C 10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aqua (Water), Bisabolol, Caprylic/Capric Triglyceride, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Decyl Oleate, Diazolidinyl Urea, Ethylhexylglycerin, Glycerin, Lactic Acid, Opuntia Ficus-Indica (Cactus) Flower Extract, Phenoxyethanol, Polysorbate 60, Potassium Sorbate, Retinyl Palmitate, Saccharum Officinarum (Sugar Cane) Extract, Sodium Benzoate, 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® All Day Moisturizing Balm

Labelling Bottle 071016

SPF 10

1.66 OZ. NET.WT.– 50 ml


Art. 03120

MADE IN GERMANY

Gesichtscreme - Facial Cream – Gezichtscrème – Crema viso – Crema Facial

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 ALL DAY MOISTURIZING BALM  SPF 10
sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:6889-0312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 20.625 g  in 50 mL
GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 50 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 5 g  in 50 mL
DECYL OLEATE (UNII: ZGR06DO97T) 5 g  in 50 mL
COCOA BUTTER (UNII: 512OYT1CRR) 5 g  in 50 mL
POLYSORBATE 60 (UNII: CAL22UVI4M) 1.5 g  in 50 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 1.0 g  in 50 mL
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 1.0 g  in 50 mL
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) 0.5 g  in 50 mL
OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA) 0.5 g  in 50 mL
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.25 g  in 50 mL
BILBERRY (UNII: 9P2U39H18W) 0.15 g  in 50 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 0.15 g  in 50 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.15 g  in 50 mL
SUGARCANE (UNII: 81H2R5AOH3) 0.05 g  in 50 mL
ALLANTOIN (UNII: 344S277G0Z) 0.05 g  in 50 mL
ORANGE (UNII: 5EVU04N5QU) 0.015 g  in 50 mL
LEMON (UNII: 24RS0A988O) 0.015 g  in 50 mL
LACTIC ACID (UNII: 33X04XA5AT) 0.015 g  in 50 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.015 g  in 50 mL
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC) 0.005 g  in 50 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.005 g  in 50 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.005 g  in 50 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:6889-0312-021 in 1 BOX11/24/2016
1NDC:6889-0312-0150 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(6889-0312)

Revised: 10/2016
Document Id: 6f4409a6-8d27-4838-a4ab-15f094dc40e7
Set id: fa788dd0-0506-472c-86f4-b81d2ae7c0fc
Version: 2
Effective Time: 20161005
 
Linde Eckstein GmbH + Co. KG