IM TONE UP MULTI BASE- octyl methoxycinnamate, homosalate, octyl 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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3

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

IM TONE UP MULTI BASE 
octyl methoxycinnamate, homosalate, octyl salicylate, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72284-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.78 g  in 50 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)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72284-0001-11 in 1 BOX03/06/2019
150 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 finalpart35203/06/2019
Labeler - Normalest Co., Ltd. (694812877)
Registrant - Normalest Co., Ltd. (694812877)
Establishment
NameAddressID/FEIBusiness Operations
Normalest Co., Ltd.694812877manufacture(72284-0001)

Revised: 3/2019
Document Id: 8356801e-f5e4-5c0e-e053-2a91aa0acb78
Set id: 8356801e-f5e3-5c0e-e053-2a91aa0acb78
Version: 1
Effective Time: 20190306
 
Normalest Co., Ltd.