IM TONE UP MULTI BASE- octyl methoxycinnamate, homosalate, octyl salicylate, titanium dioxide lotion

IM TONE UP MULTI BASE by

Drug Labeling and Warnings

IM TONE UP MULTI BASE by is a Otc medication manufactured, distributed, or labeled by Normalest Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

IM TONE UP MULTI BASE 
octyl methoxycinnamate, homosalate, octyl salicylate, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72284-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.78 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72284-0001-1	1 in 1 BOX	03/06/2019
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/06/2019

Labeler - Normalest Co., Ltd. (694812877)

Registrant - Normalest Co., Ltd. (694812877)

Establishment
Name	Address	ID/FEI	Business Operations
Normalest Co., Ltd.		694812877	manufacture(72284-0001)