Label: BERRY POWERFUL LIP CARE- dimethicone jelly

  • Category: HUMAN OTC DRUG LABEL

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 June 22, 2020

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  • ACTIVE INGREDIENT

    Active ingredient      Purpose

    Dimethicone 2.0%    Skin protectant

  • PURPOSE

    Uses

    Helps prevent and temporarily chapped or cracked lips

  • 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.

  • INDICATIONS & USAGE

    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
  • WARNINGS

    Warnings

    For external use only

    When using this product do not get into eyes

    Do not use deep on

    • Deep puncture wounds
    • Animal Bites
    • Serious burns
  • DOSAGE & ADMINISTRATION

    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, Silica Dimethyl Silylate, Silica, Terapeptide-45, Theobroma Cocoa Seed Butter, Tocopherol Acetate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water, Zea Mays (Corn) Starch.

  • PRINCIPAL DISPLAY PANEL

    Jafra Royal Jelly

    Berry Powerful Lip Care

    4 g NET WT .14 oz

    carton

  • INGREDIENTS AND APPEARANCE
    BERRY POWERFUL LIP CARE 
    dimethicone jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-278
    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
    BENZYL BENZOATE (UNII: N863NB338G)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-278-021 in 1 CARTON10/13/2017
    1NDC:68828-278-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/13/2017
    Labeler - JAFRA COSMETICS INTERNATIONA (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-278)
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