MINI BERRY LIP BALM BLUEBERRY- octinoxate, titanium dioxide 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.

----------

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 5.00%, Titanium Dioxide 0.23%

INACTIVE INGREDIENT

Inactive ingredients: Polyglyceryl-2 Triisostearate, Petrolatum, Diisostearyl Malate, Bis-Diglyceryl Polyacyladipate-2, Polybutene, Benzophenone-3, Hydroxystearic Acid, Microcrystalline Wax, Silica Dimethyl Silylate, VP/Hexadecene Copolymer, Mica (CI 77019), Sorbitan Isostearate, Red 28 Lake (CI 45410), Fragrance(Parfum), Butylparaben, Tocopheryl Acetate, Methicone, Polyglyceryl-2 Diisostearate, Red 6 (CI 15850), Yellow 5 Lake (CI 19140), Vaccinium Angustifolium (Blueberry) Fruit Extract, Water, Butylene Glycol, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Phenoxyethanol, Methylparaben, Ethylparaben, Isobutylparaben, Propylparaben

PURPOSE

PURPOSE: Sunscreen

WARNINGS

Warnings: 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 children: Keep out of reach of babies and children

INDICATIONS & USAGE

INDICATIONS AND USAGE: Apply on lip with fingers

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

Image of carton

MINI BERRY LIP BALM BLUEBERRY 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.36 g  in 7.2 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.01 g  in 7.2 g
Inactive Ingredients
Ingredient NameStrength
Petrolatum (UNII: 4T6H12BN9U)  
Diisostearyl Malate (UNII: QBS8A3XZGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-038-017.2 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2013
Labeler - TONYMOLY CO., LTD. (688216798)
Registrant - TONYMOLY CO., LTD. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO., LTD.688216798repack(59078-038)
Establishment
NameAddressID/FEIBusiness Operations
COSMAX INC.689019313manufacture(59078-038)

Revised: 3/2015
Document Id: 7ea7cc72-29ec-4e7d-9cd4-8c69e9829ead
Set id: 13c6e626-c1ac-4710-8ddb-b52fa1c23dc1
Version: 2
Effective Time: 20150304
 
TONYMOLY CO., LTD.