COVER FX BB GEL MATTIFYING ANTI-BLEMISH G LIGHT-MED- salicylic acid gel
COVER FX BB GEL MATTFYING ANTI-BLEMISH G MED-DEEP- salicylic acid gel
COVER FX BB GEL MATTIFYING ANTI-BLEMISH G DEEP- salicylic acid gel
Cover FX Skin Care, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ACTIVE INGREDIENTS

SALICYLIC ACID 1.0% W/W

PURPOSE

TREAT ACNE PIMPLES

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

USES

HELPS TREAT ACNE PIMPLES AND ALLOWS SKIN TO HEAL.

WARNINGS CAUTION

FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE PRODUCTS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE PRODUCT SHOULD BE USED UNLESS DIRECTED BY A HEALTH CARE PRACTITIONER.

DISCONTINUE USE IF SKIN IRRITATION DEVELOPS OR INCREASES. IF IRRITATION PERSISTS, CONSULT A HEALTH CARE PRACTITIONER. AVOID CONTACT WITH EYES; IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

DIRECTIONS

CLEANSE SKIN THOROUGHLY BEFORE APPLYING THE PRODUCT. APPLY PRODUCT TO AFFECTED AREAS ONE TO THREE TIMES DAILY OR AS DIRECTED BY A HEALTH CARE PRACTITIONER.

APPLY WITH THE LIQUID FOUNDATION BRUSH OR WITH FINGERTIPS AND BLEND WELL. SHAKE WELL BEFORE USE

INACTIVE INGREDIENTS

1,2 HEANEDIOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, AQUQ, BAKUCHIOL, BISABOLOL, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE AP, CERAMIDE EOP, CERAMIDE NO, CETYL ALCOHOL, CHLOESTEROL, ENANTIA CHLORANTHA BARK EXTRACT, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, OLEANOLIC ACID, PENTYLENE GLYCOL, PHENOXYETHANOL, PHYTOSPHINGOSINE, QUILLAJA SAPONARIA BARK EXTRACT, SALICYLOYL PHYTOSPINGOSINE SILICA, SODIUM HYDROXIDE, SODIUM LAUROLY LACTYLATE, SODIUM MAGNESIUM SILICATE, STEARYL ALCOHOL, TETRAHEXYLDECYL ASCORBATE, THYMUS VULGARIS (THYME) LEAF OIL, THYMUS VULGARIS (THYME) LEAF WATER, TRIETHOXYCAPRYLYLSILANE, TRILAURETH-4 PHOSPHATE, XANTHAN GUM

MAY CONTAIN TITANIUM DIOXIDE CI 77891, IRON OXIDES (CI 77492, CI 77491, CI 74499)

COVER FX BB GEL CARTON LABEL COVER FX BB GEL TUBE LABEL COVER FX BB GEL SHADE LABELS - 3 SHADES

COVER I FX

BB
GEL

MATTIFYING ANT-BLEMISH TREATMENT

30 mL/1.0 FL OZ

CLINICALLY TESTED, PARABEN, FRAGRANCE, GLUTEN, MINERAL OIL, AND TALC FREE. VEGAN.

BB GEL PROVIDES BUILDABLE COVERAGE FOR THE TREATMENT OF ACNE DURING WEAR. POWERFUL ANTIOXIDANTS AND ANTI-INFLAMMATORIES REDUCE THE APPEARANCE OF EXISTING BLEMISHES WHILE SALICYLIC ACID AND THYME EXTRACT HELP KEEP SKIN CLEAR OF NEW BLEMISHES. IT MINIMIZES THE APPEARANCE OF PORES AND SEBUM PRODUCTION THROUGHOUT THE DAY AND DRIES TO A MATTE FINISH ON THE SKIN.

YOU MAY REPORT A SERIOUS ADVERSE AFFECT FROM USE OF THE PRODUCT TO:
(USA) COVER FX, 2211 NORFOLK STREET, SUITE 1100, HOUSTON, TX 77098
(CAN) COVER FX, 1681 FLINT ROAD, TORONTO, M3J 2W8

RESPONSIBLE PERSON: OBELIS S.A. 1030 BRUSSELS

CoverF xBBGel AntiBlemCarton1 Label

CoverFx BBGel AntiBlemLgTube Label

Shade GLight-Med Label

ShadeG Med-Deep Label

Shade GDeep Label

COVER FX BB GEL MATTIFYING ANTI-BLEMISH G LIGHT-MED
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-027
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.3 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
WATER (UNII: 059QF0KO0R)
BAKUCHIOL (UNII: OT12HJU3AR)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE EOP (UNII: 88KCS7120E)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
LAPONITE (UNII: D703131383)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
THYME OIL (UNII: 2UK410MY6B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-027-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/25/2014	12/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	04/25/2014	12/31/2016

COVER FX BB GEL MATTFYING ANTI-BLEMISH G MED-DEEP
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-028
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.3 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
WATER (UNII: 059QF0KO0R)
BAKUCHIOL (UNII: OT12HJU3AR)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE EOP (UNII: 88KCS7120E)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
LAPONITE (UNII: D703131383)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
THYME OIL (UNII: 2UK410MY6B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-028-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/25/2014	12/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	04/25/2014	12/31/2016

COVER FX BB GEL MATTIFYING ANTI-BLEMISH G DEEP
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-029
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.3 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
WATER (UNII: 059QF0KO0R)
BAKUCHIOL (UNII: OT12HJU3AR)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE EOP (UNII: 88KCS7120E)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
LAPONITE (UNII: D703131383)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
THYME OIL (UNII: 2UK410MY6B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-029-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/25/2014	12/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	04/25/2014	12/31/2016

Labeler - Cover FX Skin Care, Inc. (202908021)

Registrant - Cover FX Skin Care, Inc. (202908021)

Name	Address	ID/FEI	Business Operations
Establishment
Dermaceutical Laboratories, LLC		078457159	manufacture(68327-027)

Revised: 12/2017

Document Id: 610367b3-3a3a-6183-e053-2991aa0a14b3

Set id: d2f361e3-32fe-4424-af84-fa399a36a8fb

Version: 2

Effective Time: 20171223

Cover FX Skin Care, Inc.