ISLEAF SATIN LIP AND CHEEK DUO CORAL ORANGE- dimethicone liquid

isLeaf Satin Lip and Cheek Duo Coral Orange by

Drug Labeling and Warnings

isLeaf Satin Lip and Cheek Duo Coral Orange by is a Otc medication manufactured, distributed, or labeled by C3 Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

dimethicone

INACTIVE INGREDIENT

wter butylene glycol, beeswax, etc

PURPOSE

for a gradient effect

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

For a gradient effect, apply only at the center and use the side of the cushion applicator to smudge the color outward to the corners of your mouth.

For cheeks, dot on cheeks and lightly smooth dotting by fingertip or applicator

WARNINGS

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISLEAF SATIN LIP AND CHEEK DUO CORAL ORANGE 
dimethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70818-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURYL ALCOHOL (UNII: 178A96NLP2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70818-005-01	4.5 g in 1 APPLICATOR; Type 0: Not a Combination Product	08/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/08/2017

Labeler - C3 Co., Ltd. (689846633)

Registrant - C3 Co., Ltd. (689846633)

Establishment
Name	Address	ID/FEI	Business Operations
C3 Co., Ltd.		689846633	label(70818-005) , manufacture(70818-005) , pack(70818-005)