NDC Code(s) : 46007-201-25
Packager : Skin Authority LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AGE DEFYING HYDRATING SUNSCREEN AVOBENZONE OCTINOXATE OCTISALATE OXYBENZONE HOMOSALATE OCTOCRYLENE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46007-201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 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
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE7 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE3 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
STARCH, TAPIOCA(UNII: 24SC3U704I)
ALCOHOL(UNII: 3K9958V90M)
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)
PEG/PPG-18/18 DIMETHICONE(UNII: 9H0AO7T794)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31(UNII: D9C330MD8B)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
FUCUS VESICULOSUS(UNII: 535G2ABX9M)
PANTHENOL(UNII: WV9CM0O67Z)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TOCOPHEROL(UNII: R0ZB2556P8)
DIMETHICONE(UNII: 92RU3N3Y1O)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
ISOSTEARIC ACID(UNII: X33R8U0062)
TROLAMINE(UNII: 9O3K93S3TK)
EDETATE SODIUM(UNII: MP1J8420LU)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46007-201-25150 mL in 1 TUBE 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

SKIN AUTHORITY

AGE DEFYING HYDRATING SUNSCREEN

150 ML / 5.1 FL OZ

51136(revA)150ml-AgeDefyingHydratingSunscreen