Label: ROYAL JELLY BERRY POWERFUL LIP CARE- dimethicone stick
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- NDC Code(s): 68828-704-01, 68828-704-02
- Packager: JAFRA COSMETICS INTERNATIONAL
- 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 May 11, 2022
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- ACTIVE INGREDIENT
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
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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, 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.
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INGREDIENTS AND APPEARANCE
ROYAL JELLY BERRY POWERFUL LIP CARE
dimethicone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-704 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-704-02 1 in 1 CARTON 10/13/2017 1 NDC:68828-704-01 3.7 g in 1 CYLINDER; 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 INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Distribuidora Comercial Jafra, S.A. de C.V. 951612777 manufacture(68828-704)
