SUNTIQUE IM TONE UP MULTI BASE- homosalate, ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide lotion 
Normalest 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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SUNTIQUE I'M TONE UP MULTI BASE
120 mL

SUNTIQUE I'M TONE UP MULTI BASE

Active ingredients

Octyl Methoxycinnamate 7%

Homosalate 6%

Octyl Salicylate 4.5%

Titanium Dioxide 3.5%

Inactive ingredients

Water, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Dicaprylyl Carbonate, Propanediol, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Houttuynia Cordata Extract, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Synthetic Fluorphlogopite, Methyl Methacrylate Crosspolymer, Phenoxyethanol, Squalane, Aluminum Stearate, Fragrance, Fructooligosaccharides, Polyhydroxystearic Acid, Saccharide, Hydrolysate, Pullulan, Alumina, 1,2-Hexanediol, Aluminum Hydroxide, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Iron Oxides (CI 77492), Triethoxycaprylylsilane, Disodium EDTA, Sorbitan Isostearate, Iron Oxides (CI 77491), Echium Plantagineum Seed Oil, Butylene Glycol, Glycerin, Tin Oxide, Alcohol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Malva Sylvestris (Mallow) Extract ,Melissa Officinalis Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Veronica Officinalis Extract, Tocopherol, Sodium Hydroxide

SUNTIQUE IM TONE UP MULTI BASE 
homosalate, ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72284-0012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE8.4 g  in 120 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.2 g  in 120 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.4 g  in 120 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.2 g  in 120 mL
Inactive Ingredients
Ingredient NameStrength
SQUALANE (UNII: GW89575KF9)  
FOSFRUCTOSE (UNII: M7522JYX1H)  
INVERT SUGAR (UNII: ED959S6ACY)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERIN (UNII: PDC6A3C0OX)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
PROPANEDIOL (UNII: 5965N8W85T)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SALVIA HISPANICA SEED (UNII: NU0OLX06F8)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALCOHOL (UNII: 3K9958V90M)  
CARDIOSPERMUM HALICACABUM WHOLE (UNII: 185RQ97K0V)  
MALVA SYLVESTRIS WHOLE (UNII: I01732476C)  
PRIMULA VERIS (UNII: W6LFQ57E4M)  
VERONICA OFFICINALIS WHOLE (UNII: 9EHR580PSP)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72284-0012-11 in 1 BOX07/27/2020
1120 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 finalpart35207/27/2020
Labeler - Normalest Co., Ltd. (694812877)
Registrant - Normalest Co., Ltd. (694812877)
Establishment
NameAddressID/FEIBusiness Operations
COSON Co., Ltd._Osan Plant689847210manufacture(72284-0012)

Revised: 7/2020
Document Id: ab7baaca-46a0-c872-e053-2a95a90a5509
Set id: ab7bade7-fed5-4f98-e053-2a95a90a9da2
Version: 1
Effective Time: 20200728
 
Normalest Co., Ltd.