ISLEAF SATIN LIP AND CHEEK DUO BERRY RED- dimethicone liquid 
C3 Co., Ltd.

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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Drug Facts

dimethicone

wter butylene glycol, beeswax, etc

for a gradient effect

keep out of reach of the children

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

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.

for external use only

label

ISLEAF SATIN LIP AND CHEEK DUO BERRY RED 
dimethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70818-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAURYL ALCOHOL (UNII: 178A96NLP2)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70818-004-014.5 g in 1 APPLICATOR; Type 0: Not a Combination Product08/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/08/2017
Labeler - C3 Co., Ltd. (689846633)
Registrant - C3 Co., Ltd. (689846633)
Establishment
NameAddressID/FEIBusiness Operations
C3 Co., Ltd.689846633label(70818-004) , manufacture(70818-004) , pack(70818-004)

Revised: 8/2017
Document Id: 5636f97e-88d4-6c64-e054-00144ff8d46c
Set id: 5636f97e-88d3-6c64-e054-00144ff8d46c
Version: 1
Effective Time: 20170808
 
C3 Co., Ltd.