FDA.reportPublic FDA data

Royal Jelly Berry Powerful Lip Care

Manufacturer
Distribuidora Comercial Jafra, S.A. de C.V. | Jafra Cosmetics International, Inc.
Effective date
2025-11-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:43:23

Label at a glance#

ProductRoyal Jelly Berry Powerful Lip Care
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

• Helps prevent and temporarily protects chapped or cracked lips

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Dimethicone 2.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

• Helps prevent and temporarily protects chapped or cracked lips

Warnings

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 within a few days
Do not use on
• deep or puncture wounds
• animal bites
• serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 INGREDIENT SECTION

Inactive ingredients

Prunus Armeniaca (Apricot) Kernel Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea) Butter, Sesamum Indicum (Sesame) Seed Oil, Beeswax/Cera Alba, Microcrystalline Wax, Ricinus Communis (Castor) Seed Oil, Oryza Sativa (Rice) Bran Extract, Bis-Diglyceryl Polyacyladipate-2, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soya (Soybean) Germ Extract, Silica, Boron Nitride, Benzyl Benzoate, Carthamus Tinctorius (Safflower) Seed Oil, Silica Dimethyl Silylate, Zea Mays (Corn) Starch, Phytosteryl Canola Glycerides, Lecithin, Vaccinium Angustifolium (Blueberry) Fruit Extract, Caprylic/Capric Triglyceride, Polyglyceryl-3 Diisostearate, Royal Jelly Powder, Water, Flavor, Glycerin, Tocopheryl Acetate, Dipropylene Glycol, Hydrogenated Lecithin, Phenethyl Alcohol, Royal Jelly, Ethylhexylglycerin, Maltodextrin, Tetrapeptide-45

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-704-01Royal Jelly Berry Powerful Lip Care3.7 g in 1 CYLINDERSTICK3.76
68828-704-02Royal Jelly Berry Powerful Lip Care1 in 1 CARTONSTICK16

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-70468828-704-01, 68828-704-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORON NITRIDE2U4T60A6YDIACT
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER OIL65UEH262ISIACT
DIPROPYLENE GLYCOLE107L85C40IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
SOYBEAN GERMJBW2VHD14MIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
RICE BRANR60QEP13ICIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
ALMOND OIL66YXD4DKO9IACT
APRICOT KERNEL OIL54JB35T06AIACT
CASTOR OILD5340Y2I9GIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
COCOA BUTTER512OYT1CRRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LOWBUSH BLUEBERRYG90PX41VP0IACT
WATER059QF0KO0RIACT
STARCH, CORNO8232NY3SJIACT
WHITE WAX7G1J5DA97FIACT
ROYAL JELLYL497I37F0CIACT
SESAME OILQX10HYY4QVIACT
BENZYL BENZOATEN863NB338GIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-01-02full-release2026-06-01 00:50:31

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 Berry Powerful Lip CareDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.09323fbe-76b5-48c6-80a7-c35b64110a7d2025-11-05WarningsExact identifier
ndc (package): 68828-704-01
ndc (package): 68828-704-02
ndc (product): 68828-704
ndc11 (package): 68828070402
ndc11 (package): 68828070401
spl id: 42d8496f-20e8-0550-e063-6294a90ae42a
spl set id: 09323fbe-76b5-48c6-80a7-c35b64110a7d

Reported adverse events (FAERS/openFDA)#

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