NDC Code(s) : 51150-362-01, 51150-362-02, 51150-362-03, 51150-362-04, 51150-362-05
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 Foundation Broad Spectrum SPF 20 SunscreenOctinoxate LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51150-362
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
ALCOHOL(UNII: 3K9958V90M)
ISODODECANE(UNII: A8289P68Y2)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (11 MICRONS)(UNII: Z570VEV8XK)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
ISOHEXADECANE(UNII: 918X1OUF1E)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
PERLITE(UNII: 0SG101ZGK9)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
BENZYL ALCOHOL(UNII: LKG8494WBH)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)(UNII: 255PIF62MS)
BIOTIN(UNII: 6SO6U10H04)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51150-362-011 in 1 CARTON 06/01/2017
125 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:51150-362-02125 mL in 1 BOTTLE Type 0: Not a Combination Product06/01/2017
3NDC:51150-362-031 in 1 CARTON 06/01/2017
310 mL in 1 BOTTLE Type 0: Not a Combination Product06/01/2017
4NDC:51150-362-041 in 1 CARTON 06/01/2017
45 mL in 1 BOTTLE Type 0: Not a Combination Product06/01/2017
5NDC:51150-362-051 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