NDC Code(s) : 76485-1037-1
Packager : Rimmel Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Long Lasting Finish with Comfort Serum Titanium Dioxide, Octinoxate LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76485-1037
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE2.9574 g in 301 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.8325 g in 301 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
TALC(UNII: 7SEV7J4R1U)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
MAGNESIUM SULFATE(UNII: DE08037SAB)
ZINC STEARATE(UNII: H92E6QA4FV)
DIMETHICONE(UNII: 92RU3N3Y1O)
AMODIMETHICONE (1300 CST)(UNII: 3V7U636DWN)
LAURETH-7(UNII: Z95S6G8201)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIHYDROXYSTEARIN(UNII: 06YD7896S3)
CHLORPHENESIN(UNII: I670DAL4SZ)
DIMETHICONOL (100000 CST)(UNII: OSA9UP217S)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
XANTHAN GUM(UNII: TTV12P4NEE)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
GLYCERIN(UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
FRUCTOSE(UNII: 6YSS42VSEV)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
UREA(UNII: 8W8T17847W)
LAURETH-4(UNII: 6HQ855798J)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
BUTYLPHENYL METHYLPROPIONAL(UNII: T7540GJV69)
ALLANTOIN(UNII: 344S277G0Z)
maltose(UNII: XJ6S9RV06F)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SODIUM SULFATE(UNII: 0YPR65R21J)
TREHALOSE(UNII: B8WCK70T7I)
BENZYL SALICYLATE(UNII: WAO5MNK9TU)
GERANIOL(UNII: L837108USY)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
ISOMETHYL-.ALPHA.-IONONE(UNII: 9XP4LC555B)
DEXTROSE(UNII: IY9XDZ35W2)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)(UNII: 255PIF62MS)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76485-1037-130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/01/2014

PRINCIPAL DISPLAY PANEL

Drug Facts Box

PRINCIPAL DISPLAY PANEL

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