Label: IM TONE UP MULTI BASE- octyl methoxycinnamate, homosalate, octyl salicylate, titanium dioxide lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 72284-0001-1 - Packager: Normalest Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 6, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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 lotionProduct 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)