IM SAFE FOR BABY AND SILVER- titanium dioxide lotion

IM SAFE FOR BABY AND SILVER by

Drug Labeling and Warnings

IM SAFE FOR BABY AND SILVER 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 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

INGREDIENTS AND APPEARANCE

IM SAFE FOR BABY AND SILVER 
titanium dioxide lotion

Product 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)