NDC Code(s) : 51150-403-01, 51150-403-02
Packager : SICOS ET CIE

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Yves Saint Laurent All Hours Primer Broad Spectrum SPF 18 SunscreenOctinoxate LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51150-403
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate65 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
ISODODECANE(UNII: A8289P68Y2)
ALCOHOL(UNII: 3K9958V90M)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PERLITE(UNII: 0SG101ZGK9)
NYLON-12(UNII: 446U8J075B)
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER(UNII: EX0F4CZ66H)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER(UNII: WB5K9Y35Y9)
BISMUTH OXYCHLORIDE(UNII: 4ZR792I587)
BIS-PEG/PPG-14/14 DIMETHICONE(UNII: X2I70H0QJE)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE(UNII: 230K0823CE)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
TOCOPHEROL(UNII: R0ZB2556P8)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED(UNII: 1K09F3G675)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ROSA CENTIFOLIA FLOWER(UNII: CS4TE8FF7O)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51150-403-011 in 1 CARTON 06/01/2017
140 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:51150-403-021 mL in 1 PACKET Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2017

PRINCIPAL DISPLAY PANEL

image OF A CARTON