Label: IM SAFE FOR BABY AND SILVER- titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72284-0005-1 - 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
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PRINCIPAL DISPLAY PANEL
Inactive Ingredients
Water, Propanediol, Phenyl Trimethicone, Dicaprylyl Carbonate, Methylpropanediol, Cyclomethicone, 1,2-Hexanediol, Glycereth-26, Methyl Trimethicone, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Polyglyceryl-2 Caprate, Methyl Methacrylate Crosspolymer, Sucrose Stearate, Fructooligosaccharides, Saccharide Hydrolysate, Simmondsia Chinensis (Jojoba) Seed Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cellulose Gum, Tromethamine, Hydroxypropyl Methylcellulose, Cetyl Hydroxyethylcellulose, Stearic Acid, Alumina, Betaine, Trehalose, Pullulan, Glyceryl Caprylate, Ethylhexylglycerin, Squalane, Butylene Glycol, Pentylene Glycol, Aloe Barbadensis Leaf Extract, Madecassoside, C12-15 Alkyl Benzoate, Sodium Hyaluronate, Aluminum Stearate, Polyhydroxystearic Acid
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INGREDIENTS AND APPEARANCE
IM SAFE FOR BABY AND SILVER
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72284-0005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.78 g in 50 mL Inactive Ingredients Ingredient Name Strength DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) METHYLPROPANEDIOL (UNII: N8F53B3R4R) CYCLOMETHICONE (UNII: NMQ347994Z) SALVIA HISPANICA SEED (UNII: NU0OLX06F8) FOSFRUCTOSE (UNII: M7522JYX1H) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) TROMETHAMINE (UNII: 023C2WHX2V) BETAINE (UNII: 3SCV180C9W) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SQUALANE (UNII: GW89575KF9) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) MADECASSOSIDE (UNII: CQ2F5O6YIY) INVERT SUGAR (UNII: ED959S6ACY) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SUCROSE STEARATE (UNII: 274KW0O50M) TREHALOSE (UNII: B8WCK70T7I) PULLULAN (UNII: 8ZQ0AYU1TT) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPANEDIOL (UNII: 5965N8W85T) HYPROMELLOSES (UNII: 3NXW29V3WO) STEARIC ACID (UNII: 4ELV7Z65AP) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) WATER (UNII: 059QF0KO0R) GLYCERETH-26 (UNII: NNE56F2N14) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) CENTELLA ASIATICA (UNII: 7M867G6T1U) HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 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:72284-0005-1 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(72284-0005)