ISLEAF SHINE SMOOTH LIP GLAZE SOFT PINK- mineral oil 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

mineral oil

polybutene, lauryl alcohol, etc

skin protectant

keep out of reach of the children

Open the cap, press the button to put suitable amount on the applicator and apply evenly. Keep in a place away from direct sunlight with the cap closed after use

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 SHINE SMOOTH LIP GLAZE SOFT PINK 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70818-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) 2 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70818-010-012.5 mL 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(70818-010) , pack(70818-010) , manufacture(70818-010)

Revised: 8/2017
Document Id: 57c9c06f-d40b-2851-e053-2a91aa0aa09e
Set id: 57c70385-eaa7-1cab-e053-2991aa0ae974
Version: 2
Effective Time: 20170828
 
C3 Co., Ltd.