TONYMOLY MY SUNNY WATERY SUN GEL- other skin care preparations gel 
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

Ethylhexyl Methoxycinnamate 6%

Purpose

Sunscreen

Use

This oil-free sun gel has a watery texture that applies softly and lightly to the skin, without leaving any sticky residue behind.

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.

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, ETHYLHEXYL SALICYLATE, ISOAMYL P-METHOXYCINNAMATE, BUTYLENE GLYCOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, TRIETHANOLAMINE, GLYCERIN, DIPROPYLENE GLYCOL, PEG/PPG-30/10 DIMETHICONE, CARBOMER, CAPRYLYL GLYCOL, C12-13 PARETH-23, DIVINYLDIMETHICONE/DIMETHICONE COPOLYMER, BEHENYL ALCOHOL, CETETH-10, FRAGRANCE, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALLANTOIN, CAPRYLHYDROXAMIC ACID, C12-13 PARETH-3, CHAMAECYPARIS OBTUSA LEAF EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, PORTULACA OLERACEA EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, NYMPHAEA ALBA FLOWER EXTRACT, ALOE BARBADENSIS LEAF JUICE, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, PLATINUM POWDER, POLYSORBATE 80

Principal Display Panel

product

TONYMOLY MY SUNNY WATERY SUN GEL 
other skin care preparations gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-122
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.252 g  in 45 g
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
OREGANO (UNII: 0E5AT8T16U)  
CHINESE CINNAMON (UNII: WS4CQ062KM)  
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALLANTOIN (UNII: 344S277G0Z)  
C12-13 PARETH-23 (UNII: J1WW1510L4)  
C12-13 PARETH-3 (UNII: DMC6N3419L)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETETH-10 (UNII: LF9X1PN3XJ)  
PEG/PPG-30/10 DIMETHICONE (UNII: J5JO20R8LH)  
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
AMILOXATE (UNII: 376KTP06K8)  
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)  
OCTISALATE (UNII: 4X49Y0596W)  
DOCOSANOL (UNII: 9G1OE216XY)  
WILLOW BARK (UNII: S883J9JDYX)  
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PLATINUM (UNII: 49DFR088MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-122-011 in 1 CARTON01/19/2016
145 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/14/2016
Labeler - Tonymoly Co., Ltd. (688216798)
Registrant - Tonymoly Co., Ltd. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar688732723manufacture(59078-122)

Revised: 2/2016
Document Id: 2af6e1bc-9945-188c-e054-00144ff88e88
Set id: 29ddb0ac-a375-1a20-e054-00144ff8d46c
Version: 3
Effective Time: 20160204
 
Tonymoly Co., Ltd.