PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]

PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]
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NDC 69888-103-01, 69888-103-02
Set ID d22d0785-c0c8-4c6b-b088-9f4f9435e49b
Category HUMAN OTC DRUG LABEL
Packager Royal Springs Cosmetics USA, LLC
Generic Name
Product Class Adenosine Receptor Agonist
Product Number
Application Number
  • Active ingredients

    Dimethicone (2.5%)
    Niacinamide (2%)
    Panthenol (0.5%)
    Adenosine (0.04%)

  • Purpose

    skin protectant

  • Keep out of reach of children

    - Do not swallow. In case of accidental ingestion, seek professional assistance.

  • Uses

    Skin brightening and wrinkle care. Keep skin soft and smooth.

  • Warnings

    For external use only
    Do not use when Your skin is red, inflamed, irritated or painful
    When using this product
    - Do not apply on other parts of the body
    - Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    - Do not apply directly to wound or open cut.
    Stop use and ask doctor if rash or irritation on skin develops and lasts.
    Store at room temperature

  • Directions

    Use for final step of skin care. Apply 1g amount in the palm of hand per application. Rub into skin and pat lightly.

  • Inactive ingredients

    Water, Butylene Glycol, Macadamia integrifolia seed oil, Sodium hyaluronate, Glycerin, Cyclohexasiloxane, Cyclopentasiloxane, Sodium Acrylate/Acryloyldimethyltaurate Copolymer, Isohexadecane, Polysorbate 80, Cetyl dimethicone, Cetyl ethylhexanoate, Olea europaea (olive) fruit oil, Titanium Dioxide, Dimethicone/Dimethicone Crosspolymer, Aloe Barbadensis Leaf Extract, Glyceryl Stearate, Cetyl PEG/PPG-10/1 Dimethicone, Hydrolyzed peaprotein, Lecithin, Squalane, Phytosterols, Ceramide 3, Butyspermumpurkii(shea butter), Betaine, Caprylyl Glycol, Allantoin, Beta-Glucan, Dipotassium Glycyrrhizate, Tocopheryl Acetate, Disodium EDTA

  • PRIMEROSE WHITE MILKY CB CREAM

    white milky

  • INGREDIENTS AND APPEARANCE
    PRIMEROSE WHITE MILKY CB 
    dimethicone, niacinamide, panthenol, adenosine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69888-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.025   in 80 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.02   in 80 mL
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.005   in 80 mL
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.0004   in 80 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    SQUALANE (UNII: GW89575KF9)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BETAINE (UNII: 3SCV180C9W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69888-103-021 in 1 PACKAGE02/13/2018
    1NDC:69888-103-0180 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/13/2018
    Labeler - Royal Springs Cosmetics USA, LLC (079837692)
    Registrant - Royal Springs Cosmetics USA, LLC (079837692)
    Establishment
    NameAddressID/FEIBusiness Operations
    Royal Springs Cosmetics USA, LLC079837692relabel(69888-103)
    Establishment
    NameAddressID/FEIBusiness Operations
    Royal Springs Cosmetic Co., Ltd.689514344manufacture(69888-103)

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