IM SAFE FOR SENSITIVE SKIN- titanium dioxide lotion

IM SAFE FOR SENSITIVE SKIN by

Drug Labeling and Warnings

IM SAFE FOR SENSITIVE SKIN 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 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

INGREDIENTS AND APPEARANCE

IM SAFE FOR SENSITIVE SKIN 
titanium dioxide lotion

Product 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)