Label: ROYAL JELLY BERRY POWERFUL LIP CARE- dimethicone stick

  • NDC Code(s): 68828-704-01, 68828-704-02
  • Packager: JAFRA COSMETICS INTERNATIONAL
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient (s)

    Dimethicone 2.0%

  • Purpose

    Skin Protectant

  • Uses

    • Helps prevent and temporarily protects chapped or cracked lips

  • Warnings

    For external use only

    When using this productdo not get into eyes

    Stop use and ask a doctor if
    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    Do not use on
    • deep or puncture wounds
    • animal bites
    • serious burns

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control center right away.

  • Directions

    • Apply as needed
  • INACTIVE INGREDIENT

    Inactive ingredients

    Beeswax/Cera Alba, Benzyl Benzoate, Boron Nitride, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Diglyceryl Adipate/Caprate/Caprylate/Hydroxystearate/Isostearate/Stearate, Dipropylene Glycol, Ethylhexylglycerin, Flavor/Aroma, Glycerin, Glycine Soya (Soybean) Germ Extract, Hydrogenated Lecithin, Lecithin, Maltodextrin, Microcrystalline Wax (Cera Microcrystallina), Oryza Sativa (Rice) Bran Extract, Phenethyl Alcohol, Phospholipids, Phytosteryl Canola Glycerides, Polyglyceryl-3 Diisostearate, Prunus Amygdalus dulcis (sweet Almond) Oil. Prunus Armeniaca (Apricot) Kernel Oil, Ricinus Communis (castor) seed Oil, Royal Jelly, Sesamum Indicum (sesame) seed oil, Silica Dimethyl Silylate, Silica, Terapeptide-45, Theobroma Cocoa Seed Butter, Tocopherol Acetate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water, Zea Mays (Corn) Starch.

  • Product label

    image description
  • INGREDIENTS AND APPEARANCE
    ROYAL JELLY BERRY POWERFUL LIP CARE 
    dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN GERM (UNII: JBW2VHD14M)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    WATER (UNII: 059QF0KO0R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ROYAL JELLY (UNII: L497I37F0C)  
    SESAME OIL (UNII: QX10HYY4QV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-704-021 in 1 CARTON10/13/2017
    1NDC:68828-704-013.7 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/13/2017
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-704)