BERRY POWERFUL LIP CARE- dimethicone jelly

Berry Powerful Lip Care by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

Whenusing 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

INGREDIENTS AND APPEARANCE

BERRY POWERFUL LIP CARE 
dimethicone jelly

Product 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)