ROYAL JELLY BERRY POWERFUL LIP CARE- dimethicone stick
JAFRA COSMETICS INTERNATIONAL

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.

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Royal Jelly Berry Powerful Lip Care

Active ingredient (s)

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. If swallowed, get medical help or contact a Poison Control center right away.

Directions

Apply as needed

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

image description

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/13/2017

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-704)

Revised: 2/2022

Document Id: d70a0d8c-8aba-557c-e053-2a95a90a6205

Set id: 09323fbe-76b5-48c6-80a7-c35b64110a7d

Version: 2

Effective Time: 20220202

JAFRA COSMETICS INTERNATIONAL