JAFRA FRUTERIA COCO FRESCO LIP BALM- dimethicone gel

JAFRA Fruteria Coco Fresco Lip Balm by

Drug Labeling and Warnings

JAFRA Fruteria Coco Fresco Lip Balm by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International, Inc., Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Dimethicone 1%

Purpose

Skin protectant

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

Warnings

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.

KEEP OUT OF REACH OF CHILDREN

Directions

apply as needed

Inactive Ingredients

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/Aroma, Silica Dimethyl Silylate, Oleic / Linoleic / Linolenic Polyglycerides, Dimethicone, Pouteria Sapota Seed Oil, Tocopheryl Acetate, Benzyl Alcohol, Limonene.

SPL UNCLASSIFIED SECTION

Product label

INGREDIENTS AND APPEARANCE

JAFRA FRUTERIA COCO FRESCO LIP BALM 
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
SESAME OIL (UNII: QX10HYY4QV)
SHEA BUTTER (UNII: K49155WL9Y)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
CERESIN (UNII: Q1LS2UJO3A)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
AVOCADO OIL (UNII: 6VNO72PFC1)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-010-01	1 in 1 CARTON	06/01/2023
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2023

Labeler - Jafra Cosmetics International, Inc. (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-010)