FDA.reportPublic FDA data

Berry Powerful Lip Care

Manufacturer
JAFRA COSMETICS INTERNATIONA | Jafra Manufacturing, S.A. de C.V.
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:18:33

Label at a glance#

ProductBerry Powerful Lip Care
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient      Purpose

Dimethicone 2.0%    Skin protectant

OTC - PURPOSE SECTION

Uses

Helps prevent and temporarily chapped or cracked lips

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.

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

When using this product do not get into eyes

Do not use deep on

  • Deep puncture wounds
  • Animal Bites
  • Serious burns

DOSAGE & ADMINISTRATION SECTION

Directions

Apply as needed.

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jafra Royal Jelly

Berry Powerful Lip Care

4 g NET WT .14 oz

cartoncarton

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68828-278-022022-01-28C16284748780-19d75b9d0-6c8b-f424-e053-dadaa90a57ceRoyal Jelly Berry Powerful Lip Care
68828-278-022020-06-22C16284748780-19d75b9d0-6c8b-f424-e053-dadaa90a57ceRoyal Jelly Berry Powerful Lip Care
68828-278-022020-01-31C16284748780-19d75b9d0-6c8b-f424-e053-dadaa90a57ceRoyal Jelly Berry Powerful Lip Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-278-01Berry Powerful Lip Care4 g in 1 TUBEJELLY44
68828-278-02Berry Powerful Lip Care1 in 1 CARTONJELLY14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-278BERRY POWERFUL LIP CARE (DIMETHICONE) JELLY [JAFRA COSMETICS INTERNATIONA]4Legacy NDC, 2 package rows20200623_3bcd8012-7ec1-4dea-aa9d-5eb4abf7f09b.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
68828-27868828-278-01, 68828-278-02

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
BENZYL BENZOATEN863NB338GIACT
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
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
a8b440d1-7f12-3699-e053-2a95a90a7a483bcd8012-7ec1-4dea-aa9d-5eb4abf7f09b2020-06-22WarningsExact identifier
spl id: a8b440d1-7f12-3699-e053-2a95a90a7a48
spl set id: 3bcd8012-7ec1-4dea-aa9d-5eb4abf7f09b

Reported adverse events (FAERS/openFDA)#

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