NDC Code(s) : 61957-0101-1
Packager : Parfums Christian Dior

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dior Bronze Collagen Activ SPF 15 001 OXYBENZONE, OCTINOXATE, TITANIUM DIOXIDE POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61957-0101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE2 g in 100 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE6 g in 100 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE2.43 g in 100 g
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIPALMITOYL HYDROXYPROLINE(UNII: E6AHA53N1H)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
DIMETHICONE(UNII: 92RU3N3Y1O)
LAUROYL LYSINE(UNII: 113171Q70B)
INOSITOL(UNII: 4L6452S749)
SORBIC ACID(UNII: X045WJ989B)
BENZYL SALICYLATE(UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL(UNII: T7540GJV69)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
EUGENOL(UNII: 3T8H1794QW)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61957-0101-110 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 11/23/2010

PRINCIPAL DISPLAY PANEL

DIOR BRONZE

COLLAGEN-ACTIV SPF 15

001

HEALTHY TAN

001

DIOR BRONZE

COLLAGEN-ACTIV

SPF 15

SMOOTH PROTECTION BRONZER

AGE DEFENSE TECHNOLOGY

DIOR

10g      NET WT 0.35 OZ

PRINCIPAL DISPLAY PANEL

BronzeLabel

PRINCIPAL DISPLAY PANEL

BronzeLabel2