BEAUTIPHARM BODY MOISTURIZER 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.

----------

Beautipharm® Body Moisturizer

Beautipharm® Body Moisturizer

Labelling Box 061016

SPF 10

8.3 OZ. NET.WT. – 250 ml

Art. 03150

MADE IN GERMANY

Körperlotion - Body Lotion – Body Lotion – Lozione corpo – Lotión Corporal

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

Labelling Bottle 071116

SPF 15

8.3 OZ. NET.WT. – 250 ml

Art. 03150

Made in Germany

Körperlotion - Body Lotion – Body Lotion – Lozione corpo – Lotión Corporal

Ingredients: Aqua (Water), Caprylic Capric Triglyceride, Ethylhexyl Methoxycinnamate, Decyl Oleate, Octocrylene, Polysorbate 60, Theobroma Cacao (Cocoa) Seed Butter, Fructose, Glycerin, Sorbitan Stearate, Steareth-7, Benzyl Alcohol, Stearyl Alcohol, Sodium Carbomer, Opuntia Ficus-Indica (Cactus) Flower Extract, Bisabolol, Tocopheryl Acetate, Vaccinium Myrtillus (Bilberry) Fruit Extract, 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

I-KosmEck, Bosisio Parini (LC)

CH-Intercosina AG, Aarberg

Eckstein Biokosmetik USA

Carlsbad, CA 92010

LINDE ECKSTEIN GMBH+CO.KG

90522 OBERASBACH · GERMANY

BEAUTIPHARM BODY MOISTURIZER  SPF 10
sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:6889-0315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 250 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE10 g  in 250 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 119.125 g  in 250 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 25 g  in 250 mL
DECYL OLEATE (UNII: ZGR06DO97T) 25 g  in 250 mL
POLYSORBATE 60 (UNII: CAL22UVI4M) 7.5 g  in 250 mL
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) 7.5 g  in 250 mL
FRUCTOSE (UNII: 6YSS42VSEV) 7.5 g  in 250 mL
GLYCERIN (UNII: PDC6A3C0OX) 7.5 g  in 250 mL
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) 7.5 g  in 250 mL
STEARETH-7 (UNII: 820H8P0BYX) 7.5 g  in 250 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) 2.5 g  in 250 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 2.5 g  in 250 mL
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 2.5 g  in 250 mL
OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA) 2.5 g  in 250 mL
LEVOMENOL (UNII: 24WE03BX2T) 2.5 g  in 250 mL
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.75 g  in 250 mL
BILBERRY (UNII: 9P2U39H18W) 0.75 g  in 250 mL
DEHYDROACETIC ACID (UNII: 2KAG279R6R) 0.75 g  in 250 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 0.25 g  in 250 mL
SUGARCANE (UNII: 81H2R5AOH3) 0.25 g  in 250 mL
ALLANTOIN (UNII: 344S277G0Z) 0.25 g  in 250 mL
ORANGE (UNII: 5EVU04N5QU) 0.075 g  in 250 mL
LEMON (UNII: 24RS0A988O) 0.075 g  in 250 mL
LACTIC ACID (UNII: 33X04XA5AT) 0.075 g  in 250 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.075 g  in 250 mL
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC) 0.025 g  in 250 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.025 g  in 250 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.025 g  in 250 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:6889-0315-021 in 1 BOX11/24/2016
1NDC:6889-0315-01250 mL in 1 BOTTLE, PLASTIC; 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(6889-0315)

Revised: 10/2016
Document Id: d9cc1665-7218-4df7-9f35-eae243f800bf
Set id: bcf83511-9fe2-4583-ac6b-e3e1573b9a78
Version: 2
Effective Time: 20161005
 
Linde Eckstein GmbH + Co. KG