Label: BEAUTIPHARM BODY MOISTURIZER SPF 10- sunscreen cream
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Contains inactivated NDC Code(s)
NDC Code(s): 6889-0315-01, 6889-0315-02 - Packager: Linde Eckstein GmbH + Co. KG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 5, 2016
If you are a consumer or patient please visit this version.
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Beautipharm® Body Moisturizer
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
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Beautipharm® Body Moisturizer
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
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INGREDIENTS AND APPEARANCE
BEAUTIPHARM BODY MOISTURIZER SPF 10
sunscreen creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:6889-0315 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 250 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 10 g in 250 mL Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:6889-0315-02 1 in 1 BOX 11/24/2016 1 NDC:6889-0315-01 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/30/2014 Labeler - Linde Eckstein GmbH + Co. KG (316104744) Registrant - Linde Eckstein GmbH + Co. KG (316104744) Establishment Name Address ID/FEI Business Operations Linde Eckstein GmbH + Co. KG 316104744 manufacture(6889-0315)