JAFRA FRUTERIA COCO FRESCO LIP BALM- dimethicone gel
Jafra Cosmetics International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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.

Product label

image description

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/01/2023

Labeler - Jafra Cosmetics International, Inc. (041676479)

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