NDC Code(s) : 76446-007-50
Packager : Anna Lotan Ltd

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

anna lotan PRO Protective LIGHTENING CARE UVA/UVB SPF 15 For Sun Damaged SkinOCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76446-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE70 mg in 1 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE30 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE21 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CETYL ALCOHOL(UNII: 936JST6JCN)
POLYETHYLENE GLYCOL 200(UNII: R95B8J264J)
NIACINAMIDE(UNII: 25X51I8RD4)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GLYCOL PALMITATE(UNII: T80A3T38WE)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
MORUS AUSTRALIS ROOT(UNII: 1VL55O45RF)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
ARCTOSTAPHYLOS UVA-URSI LEAF(UNII: 3M5V3D1X36)
JOJOBA OIL(UNII: 724GKU717M)
LACTIC ACID(UNII: 33X04XA5AT)
CANDELILLA WAX(UNII: WL0328HX19)
TOCOPHEROL(UNII: R0ZB2556P8)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM CETOSTEARYL SULFATE(UNII: 7ZBS06BH4B)
KOJIC ACID(UNII: 6K23F1TT52)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ASCORBYL TETRAISOPALMITATE(UNII: 47143LT58A)
.BETA.-SITOSTEROL(UNII: S347WMO6M4)
SQUALENE(UNII: 7QWM220FJH)
SQUALANE(UNII: GW89575KF9)
DUNALIELLA SALINA(UNII: F4O1DKI9A6)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76446-007-501 in 1 CARTON
150 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 11/11/2013

PRINCIPAL DISPLAY PANEL

Protective Lightening Label