NDC Code(s) : 57691-226-01
Packager : The Body Shop Wake Forest

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

The Body Shop Pomegranate Octinoxate, Octisalate, Avobenzone LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57691-226
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4.0 g in 100 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3.0 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
EDETATE CALCIUM DISODIUM ANHYDROUS(UNII: 8U5D034955)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CAFFEINE(UNII: 3G6A5W338E)
ADENOSINE(UNII: K72T3FS567)
GLYCERIN(UNII: PDC6A3C0OX)
XANTHAN GUM(UNII: TTV12P4NEE)
ISODODECANE(UNII: A8289P68Y2)
DIMETHICONE(UNII: 92RU3N3Y1O)
ARACHIDYL ALCOHOL(UNII: 1QR1QRA9BU)
DOCOSANOL(UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CETYL ALCOHOL(UNII: 936JST6JCN)
POLYOXYL 100 STEARATE(UNII: YD01N1999R)
BRAZIL NUT OIL(UNII: 0G89T29HO6)
POMEGRANATE(UNII: 56687D1Z4D)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
APPLE JUICE(UNII: 9871T0PD5P)
URSOLIC ACID(UNII: P3M2575F3F)
PUNICA GRANATUM SEED(UNII: 7294Z34NS7)
POLYISOBUTYLENE (1100000 MW)(UNII: FLT10CH37X)
POLYSORBATE 20(UNII: 7T1F30V5YH)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SORBIC ACID(UNII: X045WJ989B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57691-226-0150 mL in 1 TUBE Type 0: Not a Combination Product01/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/01/2012

PRINCIPAL DISPLAY PANEL

Pomegranate SPF 15