FDA.reportPublic FDA data

Royal Jelly Scar Balm

Manufacturer
Distribuidora Comercial Jafra, S.A. de C.V. | Jafra Cosmetics International Inc
Effective date
2025-01-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:50:32

Label at a glance#

ProductRoyal Jelly Scar Balm
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

Temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

• apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve chapped or cracked skin

Warning

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Questions?Call 1-800-551-2345 or visit www.jafra.com

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244642dimethicone 2 % Topical CreamPSN4
244642dimethicone 20 MG/ML Topical CreamSCD4
244642dimethicone 2 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01e96ee1-fe82-0132-025c-ec1559bf8b6eProduct name520260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cdProduct name320240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-004-01Royal Jelly Scar Balm1 in 1 CARTONCREAM14
68828-004-01Royal Jelly Scar Balm30 mL in 1 TUBECREAM304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-004ROYAL JELLY SCAR BALM (DIMETHICONE) CREAM [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.]4Current NDC, Legacy NDC, 2 package rows20250104_27be84c1-0227-41ca-beb6-3855eff77e41.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-00468828-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SUCRALFATEXX73205DH5IACT
CROTON LECHLERI RESINGGG6W25C63IACT
GLYCERINPDC6A3C0OXIACT
ROYAL JELLYL497I37F0CIACT
HONEYY9H1V576FHIACT
WITHANIA SOMNIFERA FLOWER2HZ95R7082IACT
NELUMBO NUCIFERA WHOLE622D93A1R1IACT
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATEW19EIO0DBEIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SHEA BUTTERK49155WL9YIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
COCOA BUTTER512OYT1CRRIACT
CETYL ALCOHOL936JST6JCNIACT
ROSA MOSCHATA SEED OILT031ZE559TIACT
YEAST .BETA.-D-GLUCAN44FQ49X6UNIACT
SACCHAROMYCES LYSATER85W246Z1CIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DMDM HYDANTOINBYR0546TOWIACT
PANTHENOLWV9CM0O67ZIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EDETATE TRISODIUM420IP921MBIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Royal Jelly Scar BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.27be84c1-0227-41ca-beb6-3855eff77e412025-01-02WarningsExact identifier
ndc (package): 68828-004-01
ndc (product): 68828-004
ndc11 (package): 68828000401
spl id: 2abe23d8-4c52-217d-e063-6394a90afbba
spl set id: 27be84c1-0227-41ca-beb6-3855eff77e41

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.