NDC Code(s) : 68327-030-01, 68327-031-01, 68327-032-01, 68327-033-01, 68327-034-01, 68327-035-01
Packager : Cover FX Skin Care, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cover Fx Blemish Treatment Concealer N X-LightSALICYLIC ACID STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68327-030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID0.025 g in 2.5 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
OCTYLDODECANOL(UNII: 461N1O614Y)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CANDELILLA WAX(UNII: WL0328HX19)
METHYL RICINOLEATE(UNII: 90FDR3O96Y)
MICA(UNII: V8A1AW0880)
C18-36 ACID TRIGLYCERIDE(UNII: ZRA72DR3R7)
PENTAERYTHRITYL ADIPATE/CAPRATE/CAPRYLATE/HEPTANOATE(UNII: GQY12B661V)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BAKUCHIOL(UNII: OT12HJU3AR)
LEVOMENOL(UNII: 24WE03BX2T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SALICYLOYL PHYTOSPHINGOSINE(UNII: U891J4JCNH)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
CERAMIDE 2(UNII: C04977SRJ5)
PALMITOYL HEXAPEPTIDE-12(UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL(UNII: 258O76T85M)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CHROMIC OXIDE(UNII: X5Z09SU859)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68327-030-012.5 g in 1 CONTAINER Type 0: Not a Combination Product07/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/01/2014
Cover Fx Blemish Treatment Concealer N LightSALICYLIC ACID STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68327-031
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID0.025 g in 2.5 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
OCTYLDODECANOL(UNII: 461N1O614Y)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CANDELILLA WAX(UNII: WL0328HX19)
METHYL RICINOLEATE(UNII: 90FDR3O96Y)
MICA(UNII: V8A1AW0880)
C18-36 ACID TRIGLYCERIDE(UNII: ZRA72DR3R7)
PENTAERYTHRITYL ADIPATE/CAPRATE/CAPRYLATE/HEPTANOATE(UNII: GQY12B661V)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BAKUCHIOL(UNII: OT12HJU3AR)
LEVOMENOL(UNII: 24WE03BX2T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SALICYLOYL PHYTOSPHINGOSINE(UNII: U891J4JCNH)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
CERAMIDE 2(UNII: C04977SRJ5)
PALMITOYL HEXAPEPTIDE-12(UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL(UNII: 258O76T85M)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CHROMIC OXIDE(UNII: X5Z09SU859)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68327-031-012.5 g in 1 CONTAINER Type 0: Not a Combination Product07/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/01/2014
Cover Fx Blemish Treatment Concealer N MediumSALICYLIC ACID STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68327-032
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID0.025 g in 2.5 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
OCTYLDODECANOL(UNII: 461N1O614Y)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CANDELILLA WAX(UNII: WL0328HX19)
METHYL RICINOLEATE(UNII: 90FDR3O96Y)
MICA(UNII: V8A1AW0880)
C18-36 ACID TRIGLYCERIDE(UNII: ZRA72DR3R7)
PENTAERYTHRITYL ADIPATE/CAPRATE/CAPRYLATE/HEPTANOATE(UNII: GQY12B661V)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BAKUCHIOL(UNII: OT12HJU3AR)
LEVOMENOL(UNII: 24WE03BX2T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SALICYLOYL PHYTOSPHINGOSINE(UNII: U891J4JCNH)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
CERAMIDE 2(UNII: C04977SRJ5)
PALMITOYL HEXAPEPTIDE-12(UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL(UNII: 258O76T85M)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CHROMIC OXIDE(UNII: X5Z09SU859)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68327-032-012.5 g in 1 CONTAINER Type 0: Not a Combination Product07/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/01/2014
Cover Fx Blemish Treatment Concealer N Med-DeepSALICYLIC ACID STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68327-033
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID0.025 g in 2.5 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
OCTYLDODECANOL(UNII: 461N1O614Y)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CANDELILLA WAX(UNII: WL0328HX19)
METHYL RICINOLEATE(UNII: 90FDR3O96Y)
MICA(UNII: V8A1AW0880)
C18-36 ACID TRIGLYCERIDE(UNII: ZRA72DR3R7)
PENTAERYTHRITYL ADIPATE/CAPRATE/CAPRYLATE/HEPTANOATE(UNII: GQY12B661V)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BAKUCHIOL(UNII: OT12HJU3AR)
LEVOMENOL(UNII: 24WE03BX2T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SALICYLOYL PHYTOSPHINGOSINE(UNII: U891J4JCNH)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
CERAMIDE 2(UNII: C04977SRJ5)
PALMITOYL HEXAPEPTIDE-12(UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL(UNII: 258O76T85M)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CHROMIC OXIDE(UNII: X5Z09SU859)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68327-033-012.5 g in 1 CONTAINER Type 0: Not a Combination Product07/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/01/2014
Cover Fx Blemish Treatment Concealer N DeepSALICYLIC ACID STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68327-034
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID0.025 g in 2.5 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
OCTYLDODECANOL(UNII: 461N1O614Y)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CANDELILLA WAX(UNII: WL0328HX19)
METHYL RICINOLEATE(UNII: 90FDR3O96Y)
MICA(UNII: V8A1AW0880)
C18-36 ACID TRIGLYCERIDE(UNII: ZRA72DR3R7)
PENTAERYTHRITYL ADIPATE/CAPRATE/CAPRYLATE/HEPTANOATE(UNII: GQY12B661V)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BAKUCHIOL(UNII: OT12HJU3AR)
LEVOMENOL(UNII: 24WE03BX2T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SALICYLOYL PHYTOSPHINGOSINE(UNII: U891J4JCNH)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
CERAMIDE 2(UNII: C04977SRJ5)
PALMITOYL HEXAPEPTIDE-12(UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL(UNII: 258O76T85M)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CHROMIC OXIDE(UNII: X5Z09SU859)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68327-034-012.5 g in 1 CONTAINER Type 0: Not a Combination Product07/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/01/2014
Cover Fx Blemish Treatment Concealer N X-DeepSALICYLIC ACID STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68327-035
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID0.025 g in 2.5 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
OCTYLDODECANOL(UNII: 461N1O614Y)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CANDELILLA WAX(UNII: WL0328HX19)
METHYL RICINOLEATE(UNII: 90FDR3O96Y)
MICA(UNII: V8A1AW0880)
C18-36 ACID TRIGLYCERIDE(UNII: ZRA72DR3R7)
PENTAERYTHRITYL ADIPATE/CAPRATE/CAPRYLATE/HEPTANOATE(UNII: GQY12B661V)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BAKUCHIOL(UNII: OT12HJU3AR)
LEVOMENOL(UNII: 24WE03BX2T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SALICYLOYL PHYTOSPHINGOSINE(UNII: U891J4JCNH)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
CERAMIDE 2(UNII: C04977SRJ5)
PALMITOYL HEXAPEPTIDE-12(UNII: HO4ZT5S86C)
PEG-10 RAPESEED STEROL(UNII: 258O76T85M)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CHROMIC OXIDE(UNII: X5Z09SU859)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68327-035-012.5 g in 1 CONTAINER Type 0: Not a Combination Product07/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/01/2014

PRINCIPAL DISPLAY PANEL

COVER l FX

BLEMISH TREATMENT CONCEALER

2.5g/0.08 OZ e NPN 80052114

CLINICALLY TESTED, PARABEN, FRAGRANCE, GLUTEN, MINERAL OIL AND TALC FREE, VEGAN
THIS CONCEALER OFFERS LONG WEARING COMPLETE COVERAGE PLUS FIGHTS BLEMISHES DURING WEAR. THE FULL COVERAGE FORMULA COVERS IMPERFECTIONS WHILE 1% SALICYLIC ACID HELPS CLEAR AND PREVENT BLEMISHES.

DIST. BY/PAR
COVER FX SKIN CARE INC
TORONTO, ONTARIO CANADA M3J2W8
MADE IN USA
WWW.COVERFX.COM
RESPONSIBLE PERSONS:- OBELIS S.A., 1030 BRUSSELS

BlemishConseal

BlemishConseal

BlemishConseal

BlemishConseal

BlemishConseal

BlemishConseal

BlemishConseal

BlemishConseal