TONYMOLY MY SUNNY WATERPROOF SUN BLOCK- suntan gels, creams, and liquids 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 Ingredients

Dipropylene Glycol 4.00%, Glycerin 2.00%, Titanium Dioxide 3.51%, Zinc Oxide 13.44%

Purpose

Sunscreen SPF50++

Use

This perfect sun block uses a strong UV protection system that is resistant against water, sweat, and sebum secretion. It is gentle on skin and protects the skin from harmful external factors when exposed to the outdoors.

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

During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet sunlight.

Inactive Ingredients

WATER, CYCLOPENTASILOXANE, PEG-10 DIMETHICONE, BUTYLOCTYL SALICYLATE, DICAPRYLYL CARBONATE, BIOSACCHARIDE GUM-1, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, METHYL METHACRYLATE CROSSPOLYMER, METHICONE, PORTULACA OLERACEA EXTRACT, ALUMINUM HYDROXIDE, DIMETHICONE, PHENOXYETHANOL, CALCIUM ALUMINUM BOROSILICATE, FRAGRANCE, STEARIC ACID, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, POLYGLYCERYL-6 POLYRICINOLEATE, TOCOPHERYL ACETATE, MICROCRYSTALLINE CELLULOSE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CHAMAECYPARIS OBTUSA LEAF EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, CELLULOSE GUM, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, NYMPHAEA ALBA FLOWER EXTRACT, ALOE BARBADENSIS LEAF JUICE, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, PLATINUM POWDER, POLYSORBATE 80

Principal Display Panel

Carton

TONYMOLY MY SUNNY WATERPROOF SUN BLOCK 
suntan gels, creams, and liquids cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8.064 g  in 60 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.106 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
WILLOW BARK (UNII: S883J9JDYX)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-108-021 in 1 CARTON01/14/2016
160 g in 1 TUBE; 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
Kolmar688732723manufacture(59078-108)

Revised: 2/2016
Document Id: 2ad097f6-6547-67d0-e054-00144ff8d46c
Set id: 2964e6c5-6ce1-3052-e054-00144ff8d46c
Version: 5
Effective Time: 20160202
 
Tonymoly Co., Ltd.