Label: BERRY POWERFUL LIP CARE- dimethicone jelly
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-278-01, 68828-278-02 - Packager: JAFRA COSMETICS INTERNATIONA
- 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 June 22, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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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
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INGREDIENTS AND APPEARANCE
BERRY POWERFUL LIP CARE
dimethicone jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-278 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-278-02 1 in 1 CARTON 10/13/2017 1 NDC:68828-278-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/13/2017 Labeler - JAFRA COSMETICS INTERNATIONA (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-278)