Label: BEAUTIPHARM ALL DAY MOISTURIZING BALM 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® 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

  • INGREDIENTS AND APPEARANCE
    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)