Label: IM SAFE FOR SENSITIVE SKIN- titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72284-0007-1 - Packager: Normalest Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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 April 23, 2019
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PRINCIPAL DISPLAY PANEL
Active Ingredients
Titanium Dioxide
Inactive Ingredients
Water, Propanediol, Phenyl Trimethicone, Dicaprylyl Carbonate, Methylpropanediol, Cyclopentasiloxane,1,2-Hexanediol, Glycereth-26, Methyl Trimethicone, Polyglyceryl-2 Caprate, Methyl Methacrylate Crosspolymer, Styrene/Acrylates Copolymer ,Sucrose Stearate, Tromethamine, Simmondsia Chinensis (Jojoba) Seed Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cellulose Gum, Hydroxypropyl Methylcellulose, Cetyl Hydroxyethylcellulose, Stearic Acid, Alumina, Betaine, Trehalose, Glyceryl Caprylate, Butylene Glycol, Pentylene Glycol, Ethylhexylglycerin, Squalane, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Madecassoside, Butylene Glycol Dicaprylate/Dicaprate, Carbomer, Polyacrylate Crosspolymer-6, t-Butyl Alcohol
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INGREDIENTS AND APPEARANCE
IM SAFE FOR SENSITIVE SKIN
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72284-0007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.785 g in 50 mL Inactive Ingredients Ingredient Name Strength SUCROSE STEARATE (UNII: 274KW0O50M) BETAINE (UNII: 3SCV180C9W) TREHALOSE (UNII: B8WCK70T7I) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) PENTYLENE GLYCOL (UNII: 50C1307PZG) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SQUALANE (UNII: GW89575KF9) CENTELLA ASIATICA (UNII: 7M867G6T1U) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) WATER (UNII: 059QF0KO0R) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PROPANEDIOL (UNII: 5965N8W85T) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) JOJOBA OIL (UNII: 724GKU717M) TROMETHAMINE (UNII: 023C2WHX2V) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALOE VERA LEAF (UNII: ZY81Z83H0X) MADECASSOSIDE (UNII: CQ2F5O6YIY) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) HYPROMELLOSES (UNII: 3NXW29V3WO) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) GLYCERETH-26 (UNII: NNE56F2N14) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72284-0007-1 1 in 1 BOX 04/24/2019 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 04/24/2019 Labeler - Normalest Co., Ltd. (694812877) Registrant - Normalest Co., Ltd. (694812877) Establishment Name Address ID/FEI Business Operations Normalest Co., Ltd. 694812877 manufacture(72284-0007)