ROYAL JELLY BERRY POWERFUL LIP CARE- dimethicone stick

Royal Jelly Berry Powerful Lip Care by

Drug Labeling and Warnings

Royal Jelly Berry Powerful Lip Care by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Dimethicone 2.0%

Purpose

Skin Protectant

Uses

Helps prevent and temporarily protects chapped or cracked lips

Warnings

For external use only

When using this product do 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

INGREDIENTS AND APPEARANCE

ROYAL JELLY BERRY POWERFUL LIP CARE 
dimethicone stick

Product 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)
BENZYL BENZOATE (UNII: N863NB338G)

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 Drug	M016	10/13/2017

Labeler - Distribuidora Comercial Jafra, S.A. de C.V. (951612777)

Registrant - Jafra Cosmetics International, Inc. (031183599)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-704)