Label: BEAUTIPHARM BODY MOISTURIZER SPF 10- sunscreen cream

  • 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

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)