FDA.reportPublic FDA data

JAFRA Fruteria Coco Fresco Lip Balm

Manufacturer
Distribuidora Comercial Jafra, S.A. de C.V. | Jafra Cosmetics International Inc
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:40:23

Label at a glance#

ProductJAFRA Fruteria Coco Fresco Lip Balm
Active ingredientDIMETHICONE
Label structure7 sections

Indications and uses

Helps prevent and temporarily protects and helps relieve chapped or cracked lips Helps prevent and protect from the drying effects of wind and cold weather

Dosage and administration

• apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent and temporarily protects and helps relieve chapped or cracked lips
  • Helps prevent and protect from the drying effects of wind and cold weather

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 in a few days
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

Polybutene, Bis-Diglyceryl Polyacyladipate-2, Sesamum Indicum (Sesame) Seed Oil, Butyrospermum Parkii (Shea) Butter, Prunus Armeniaca (Apricot) Kernel Oil, Ozokerite, Garcinia Indica Seed Butter, Persea Gratissima (Avocado) Oil, Flavor, Silica Dimethyl Silylate, Oleic / Linoleic / Linolenic Polyglycerides, Pouteria Sapota Seed Oil, Tocopheryl Acetate, Benzyl Alcohol, Limonene.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image 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
68828-010-01JAFRA Fruteria Coco Fresco Lip Balm1 in 1 CARTONGEL13
68828-010-01JAFRA Fruteria Coco Fresco Lip Balm15 mL in 1 TUBEGEL153

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-01068828-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
SESAME OILQX10HYY4QVIACT
SHEA BUTTERK49155WL9YIACT
APRICOT KERNEL OIL54JB35T06AIACT
CERESINQ1LS2UJO3AIACT
GARCINIA INDICA SEED BUTTERUS2H3D7800IACT
AVOCADO OIL6VNO72PFC1IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZYL ALCOHOLLKG8494WBHIACT
LIMONENE, (+)-GFD7C86Q1WIACT
POUTERIA SAPOTA WHOLEXOW0YP6U15IACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-12-26full-release2026-06-01 00:49:12

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
JAFRA Fruteria Coco Fresco Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.9895a320-8a74-4b27-9bf1-4b492f89888c2025-10-21WarningsExact identifier
ndc (package): 68828-010-01
ndc (product): 68828-010
ndc11 (package): 68828001001
spl id: 41ad5581-5b88-1c8b-e063-6294a90a2ba6
spl set id: 9895a320-8a74-4b27-9bf1-4b492f89888c

Reported adverse events (FAERS/openFDA)#

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