NDC Code(s) : 66184-420-01, 66184-420-02, 66184-420-03
Packager : Coty US LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ck one 3-in-1 face makeup Titanium Dioxide LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66184-420
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 Dioxide7.5 mL in 30 mL
Octinoxate (UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate 0.6 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Neopentyl Glycol (UNII: QI80HXD6S5)
Butylene Glycol (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
Tricaprin (UNII: O1PB8EU98M)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methyl Methacrylate (UNII: 196OC77688)
Caprylyl Glycol (UNII: 00YIU5438U)
Aluminum Dimyristate (UNII: J2KA067N9O)
Triethoxycaprylylsilane(UNII: LDC331P08E)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Disodium Stearoyl Glutamate (UNII: 45ASM2L11M)
Sorbic Acid (UNII: X045WJ989B)
Alaria Esculenta (UNII: EJ9JK8J58D)
Tocopherol (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66184-420-0130 mL in 1 CONTAINER
2NDC:66184-420-0230 mL in 1 BOX
3NDC:66184-420-0310 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/01/2012

LABELER - Coty US LLC(789573201)

REGISTRANT - Coty Inc.(958662223)

Establishment
Name Address ID/FEI Business Operations
Lancaster S.A.M. 401011325 manufacture

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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