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Samhealthyskin B.B. SUNSCREEN BROAD SPECTRUM SPF 40 (Samhealthyskin.COM LLC)

Available Formats

Dosage Form Package Information Links
CREAM 50 mL in 1 BOTTLE, PUMP (57650-159-79) Label Information

Complete Samhealthyskin B.B. SUNSCREEN BROAD SPECTRUM SPF 40 Information

  • Samhealthyskin B.B. SUNSCREEN CREAM BROAD SPECTRUM SPF 40



  • Active ingredient

    Titanium Dioxide 10%


  • Purpose

    Sunscreen


  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • 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 swallowed, get medical help or contact Poison Control Center right away.


  • Directions

    For sunscreen use

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating

    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 value 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-sleeved shirts, pants, hats and sunglasses


    Children under 6 months of age: Ask a doctor


  • Other Information

    Protect the product in this container from excessive heat and direct sun.


  • Inactive ingredients

    WATER, MINERAL OIL, CYCLOMETHICONE, PROPYLENE GLYCOL, DIMETHICONE/PEG-10/15 CROSSPOLYMER, CETYL PEG/PPG-10/1 DIMETHICONE, TALC, IRON OXIDES, HYALURONIC ACID, BEESWAX, MICROCRYSTALLINE WAX, SHEA (BUTYROSPERMUM PARKII) BUTTER, TRIBEHENIN, SORBITAN SESQUIOLEATE, SOLUBLE COLLAGEN, TOCOPHERYL ACETATE, ALLANTOIN, TEA (CAMELLIA SINENSIS) LEAF EXTRACT, WHITE MULBERRY (MORUS ALBA) BARK EXTRACT, LICORICE (GLYCYRRHIZA GLABRA) ROOT EXTRACT, DIPOTASSIUM GLYCYRRHIZATE, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, DISODIUM EDTA, RED GINSENG (PANAX GINSENG)EXTRACT, SODIUM CHLORIDE, FRAGRANCE


  • Samhealthyskin B.B. SUNSCREEN CREAM BROAD SPECTRUM SPF 40 1.69oz/50ml (57650-159-79)

    Outer

    Inner


  • INGREDIENTS AND APPEARANCE
    SAMHEALTHYSKIN B.B. SUNSCREEN BROAD SPECTRUM SPF 40  
    titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57650-159
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 100 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    LICORICE (UNII: 61ZBX54883)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57650-159-79 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 04/25/2013
    Labeler - Samhealthyskin.COM LLC (067387798)
    Registrant - Samhealthyskin.COM LLC (067387798)
    Establishment
    Name Address ID/FEI Business Operations
    Art Nouveau 557796198 manufacture(57650-159)