MY SUNNY POWDE RY FINISH SUN MILK- titanium dioxide, octinoxate, zinc oxide 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 ingredient: Titanium Dioxide 4.15%, Ethylhexyl Methoxycinnamate 4.0%, Zinc Oxide 2.88%

INACTIVE INGREDIENT

Inactive Ingredient: Water, Cyclopentasiloxane, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Silica, Bis-PEG/PPG-14/14 Dimethicone, Polymethyl Methacrylate, 4-Methylbenzylidene Camphor, Hexyldecyl Myristoyl Methylaminopropionate, Quaternium-18 Bentonite, Sorbitan Sesquioleate, Tilia Platyphyllos Flower Extract, Anthemis Nobilis Flower Water, Lavandula Angustifolia (Lavender) Flower Water, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Fragrance, Magnesium Sulfate, Codium Tomentosum Extract, Hydrogen Dimethicone, Aloe Barbadensis Leaf Juice, Enteromorpha Compressa Extract, Nymphaea Alba Flower Extract, Sodium Benzoate, Glycerin, Disodium EDTA, Potassium Sorbate, Pseudoalteromonas Ferment Extract, CI 77492, Alcohol, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Ecklonia Cava Extract, Mesembryanthemum Crystallinum Extract, CI 77491, Citric Acid, Sodium Hyaluronate, Ethylhexylglycerin, PVP, Platinum Powder

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. When using this product do not get into eyes. Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DESCRIPTION

Use: Helps prevent and relieve chapped or cracked skin.

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MY SUNNY POWDE RY FINISH SUN MILK 
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.86 g  in 45 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.80 g  in 45 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.29 g  in 45 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-309-021 in 1 CARTON05/01/2016
1NDC:59078-309-0145 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2016
Labeler - TONYMOLY CO.,LTD (688216798)
Registrant - TONYMOLY CO.,LTD (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO.,LTD688216798manufacture(59078-309)

Revised: 6/2016
Document Id: 0032aaf3-6958-468d-ac2b-7c8ab30dc572
Set id: ad7c9932-79bb-4810-a1b0-6e6f0a75da47
Version: 1
Effective Time: 20160614
 
TONYMOLY CO.,LTD