NDC Code(s) : 13733-296-01, 13733-297-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Frida Kahlo Edition Tension Pact Intense Moisture SPF37 No21Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-296
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE5 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE9.7 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.9 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PENTYLENE GLYCOL(UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
WATER(UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
NIACINAMIDE(UNII: 25X51I8RD4)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-296-0114 g in 1 CARTON Type 0: Not a Combination Product02/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/01/2017
Frida Kahlo Edition Tension Pact Intense Moisture SPF37 No23Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-297
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE5 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE9.7 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.9 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PENTYLENE GLYCOL(UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
WATER(UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
NIACINAMIDE(UNII: 25X51I8RD4)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-297-0114 g in 1 CARTON Type 0: Not a Combination Product02/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/01/2017

PRINCIPAL DISPLAY PANEL

FK_TensionPactIntenseMoisture

PRINCIPAL DISPLAY PANEL

FK_TensionPactIntenseMoistureNo23