NDC Code(s) : 66472-038-01
Packager : Benefit Cosmetics, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 04 MEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66472-038
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE50 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE47 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
NYLON-12(UNII: 446U8J075B)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ISOTRIDECYL ISONONANOATE(UNII: WEF51750MT)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
POLYGLYCERYL-2 DIISOSTEARATE(UNII: DG195GP57P)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
ALUMINUM OXIDE(UNII: LMI26O6933)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
TOCOPHEROL(UNII: R0ZB2556P8)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
STEARYL GLYCYRRHETINATE(UNII: 3YYE6VJS0P)
XANTHAN GUM(UNII: TTV12P4NEE)
ACACIA(UNII: 5C5403N26O)
SODIUM STEARATE(UNII: QU7E2XA9TG)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
SERINE(UNII: 452VLY9402)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
BISMUTH OXYCHLORIDE(UNII: 4ZR792I587)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66472-038-0135 mL in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/13/2013

PRINCIPAL DISPLAY PANEL

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