TONYMOLY KISS KISS LIP ESSENCE BALM- octinoxate cream 
TONYMOLY 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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ACTIVE INGREDIENT

Active Ingredient: Ethylhexyl Methoxycinnamate 5%

INACTIVE INGREDIENT

Inactive Ingredients:
Polyglyceryl-2 Triisostearate, Polybutene, Diisostearyl Malate, Petrolatum, Pentaerythrityl Tetraethylhexanoate, Microcrystalline Wax, Benzophenone-3, Hydroxystearic Acid, Silica Dimethyl Silylate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Fragrance(Parfum), Butylparaben, Tocopheryl Acetate, Yellow 6 Lake (CI 15985), Water, Honey Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warning:
1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children

INDICATIONS AND USAGE

Indications and usage: Melt onto fingers and softly spread it on the lips

DOSAGE AND ADMINISTRATION

Dosage and administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

TONYMOLY KISS KISS LIP ESSENCE BALM 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.36 g  in 7.2 g
Inactive Ingredients
Ingredient NameStrength
Petrolatum (UNII: 4T6H12BN9U)  
Silica Dimethyl Silylate (UNII: EU2PSP0G0W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-046-017.2 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2014
Labeler - TONYMOLY CO., LTD. (688216798)
Registrant - TONYMOLY CO., LTD. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO., LTD.688216798manufacture(59078-046)

Revised: 6/2014
Document Id: 53cc4347-b0da-4dfb-b9ed-e13dd2846ff5
Set id: 71b73c2e-bdb8-4202-b491-42f2b7881e05
Version: 1
Effective Time: 20140625
 
TONYMOLY CO., LTD.