IM SAFE FOR BABY AND SILVER- 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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Active Ingredient

Titamin Dioxide 3.57 %

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

IM SAFE FOR BABY AND SILVER 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72284-0005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.78 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72284-0005-11 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(72284-0005)

Revised: 3/2019
Document Id: 83186695-f094-45d0-e053-2a91aa0a827d
Set id: 83186695-f093-45d0-e053-2a91aa0a827d
Version: 1
Effective Time: 20190306
 
Normalest Co., Ltd.