NDC Code(s) : 46007-202-12
Packager : Skin Authority LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AGE DEFYING MOISTURIZER AVOBENZONE OCTINOXATE OCTISALATE OXYBENZONE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46007-202
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2 g in 100 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE6 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
DIPROPYLENE GLYCOL DIBENZOATE(UNII: 6OA5ZDY41O)
PPG-15 STEARYL ETHER BENZOATE(UNII: 80D2J6361M)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
CYCLOMETHICONE(UNII: NMQ347994Z)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CORN OIL(UNII: 8470G57WFM)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
FUCUS VESICULOSUS(UNII: 535G2ABX9M)
PANTHENOL(UNII: WV9CM0O67Z)
DIPALMITOYL HYDROXYPROLINE(UNII: E6AHA53N1H)
TOCOPHEROL(UNII: R0ZB2556P8)
GLYCERIN(UNII: PDC6A3C0OX)
CETYL PHOSPHATE(UNII: VT07D6X67O)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
POLYSILICONE-15(UNII: F8DRP5BB29)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)(UNII: J2S07SB0YL)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
STEARIC ACID(UNII: 4ELV7Z65AP)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
PPG-5-CETETH-20(UNII: 4AAN25P8P4)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
ECHINACEA PURPUREA(UNII: QI7G114Y98)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SQUALANE(UNII: GW89575KF9)
ALLANTOIN(UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL LINOLEATE, D-(UNII: G0N132Q0ED)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
PYRIDOXINE DIPALMITATE(UNII: HB49XCT029)
STEARYL GLYCYRRHETINATE(UNII: 3YYE6VJS0P)
MILLET(UNII: TJR6B3R47P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46007-202-1250 mL in 1 BOTTLE Type 0: Not a Combination Product19/04/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 04/19/2012

LABELER - Skin Authority LLC(136549396)

PRINCIPAL DISPLAY PANEL

51127(revB) AgeDefyingMoisturizer