ROYAL JELLY SCAR BALM- dimethicone cream 
Jafra Cosmetics International Inc

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Active ingredient

Dimethicone 2%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin

Warning

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 in 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.

Direction

• apply as needed

Inactive ingredients

Water/Aqua, Caprylic/Capric Triglyceride, Aluminum Sucrose Octasulfate, Croton Lechleri Resin Extract, Glycerin, Royal Jelly, Honey/Mel, Withania Somniferia (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Polyglyceryl-3 Methylglucose Distearate, C12-15 Alkyl Benzoate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter) Fruit, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Theobroma Cocoa Seed Butter, Cetyl Alcohol, Rosa Moschata Seed Oil, Beta-Glucan, Saccharomyces Lysate Extract, Tocopheryl Acetate, DMDM Hydantoin, Panthenol, Diazolidinyl Urea, Trisodium EDTA

Product label

image description
ROYAL JELLY SCAR BALM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SUCRALFATE (UNII: XX73205DH5)  
CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
GLYCERIN (UNII: PDC6A3C0OX)  
ROYAL JELLY (UNII: L497I37F0C)  
HONEY (UNII: Y9H1V576FH)  
WITHANOLIDE D (UNII: XY366XV8JT)  
NELUMBO NUCIFERA WHOLE (UNII: 622D93A1R1)  
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)  
YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PANTHENOL (UNII: WV9CM0O67Z)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-004-011 in 1 CARTON06/15/2022
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01606/15/2022
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-004)

Revised: 12/2023
Document Id: 0daa6114-98bb-7f8b-e063-6294a90a6fc5
Set id: 27be84c1-0227-41ca-beb6-3855eff77e41
Version: 3
Effective Time: 20231229
 
Jafra Cosmetics International Inc