TONYMOLY FACE MIX SKIN MAKEUP BASE 02 MIX LAVENDAR SPF20- other skin care preparations lotion 
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 Ingredients

Dimethicone 1.00%, Ethylhexyl Methoxycinnamate 4.00%, Glycerin 2.00%, Titanium Dioxide 9.45%, Zinc Oxide 1.00%

Purpose

Skin Protectant

Use

SPF20 PA++

4-in-1 makeip base for healthy skin tone and clean and balanced skin.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Keep out of reach of children

Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Directions

After using our basic skin care products, apply an appropriate amount evenly to the face and gently pat to have an smooth finish.

Inactive Ingredients

Water, Cyclopentasiloxane, Nelumbo Nucifera Flower Water, Cyclohexasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclomethicone, PEG10 Dimethicone, Dicaprylyl Carbonate, Hexyldecyl Myristoyl Methylaminopropionate, Maltitol, Disteardimonium Hectorite, Ultramarines (CI 77007), Magnesium Sulfate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Tribehenin, Cetyl PEG/PPG10/1 Dimethicone, Ceresin, Fragrance(Parfum), Triethoxycaprylylsilane, Methyl Methacrylate Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Disodium EDTA, Boron Nitride, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydrolyzed Collagen, Ceramide 3, Sodium Hyaluronate, Ascorbic Acid, Butylene Glycol, Polysilicone11, Aspalathus Linearis Extract, Lilium Candidum Flower Extract, Borago Officinalis Extract, Salvia Officinalis (Sage) Leaf Extract, Centaurea Cyanus Flower Extract, Anthemis Nobilis Flower Extract, Trimethylsiloxysilicate, Copernicia Cerifera (Carnauba) Wax

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product

TONYMOLY FACE MIX SKIN MAKEUP BASE 02 MIX LAVENDAR SPF20 
other skin care preparations lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-138
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.6 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.835 g  in 30 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.3 g  in 30 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.3 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
ULTRAMARINE BLUE (UNII: I39WR998BI)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ)  
BORAGO OFFICINALIS WHOLE (UNII: 69R58A6YLI)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
WATER (UNII: 059QF0KO0R)  
NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
CERESIN (UNII: Q1LS2UJO3A)  
CERAMIDE 3 (UNII: 4370DF050B)  
ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)  
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE (UNII: 1959TW0O9A)  
MALTITOL (UNII: D65DG142WK)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-138-011 in 1 CARTON01/19/2016
130 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/14/2016
Labeler - Tonymoly Co., Ltd. (688216798)
Registrant - Tonymoly Co., Ltd. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax689049693manufacture(59078-138)

Revised: 2/2016
Document Id: 2abb1649-6b3a-50b7-e054-00144ff8d46c
Set id: 2a41fdd9-9fa4-4e10-e054-00144ff88e88
Version: 2
Effective Time: 20160201
 
Tonymoly Co., Ltd.