COVER FX MATTIFYING PRIME AND SET- salicylic acid 
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.

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Cover FX Mattifying Prime and Set Kit

Drug Facts

Active Ingredient

Salicylic Acid 1.0% w/w

Purpose

Acne Treatment

Use

  • For the treatment of acne
  • Helps treat acne pimples and allows skin to heal

Warnings

For external use only

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if excessive skin irritation develops or increases.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

  • Clean skin thoroughly before applying
  • Cover entire affected area with a thin layer 1 to 3 times daily
  • Because excessive drying of the skin may occur, start with 1 application, then gradually increase to 2 or 3 if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredients

Cyclopentasiloxane, Salix Nigra (Willow) Bark Extract, Water, Dimethicone Crosspolymer, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-PEG/PPG-14/14 Dimethicone, Vaccinium Myrtillus Fruit Extract, Glycerin, Dimethicone, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Squalane, Phenyl Methicone, Saccharum Officinarum (Sugar Cane) Extract, Bisabolol, Caprylyl Glycol, Tocopherol, Dimethiconol, Phenoxyethanol, PEG-60 Almond Glycerides, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Enantia Chlorantha Bark Extract, Citrus Limon (Lemon) Fruit Extract, Phytosphingosine, Tetrahexyldecyl Ascorbate, Ethyl Linoleate, Ethyl Linolenate, Ethyl Oleate, Carbomer, Silica, Polysorbate 20, Oleanolic Acid, Nordihydroguaiaretic Acid, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7

DIST. BY COVER FX SKIN CARE INC. TORONTO, ONTARIO CANADA M3J 2W8

PRINCIPAL DISPLAY PANEL - Kit Carton

COVER | FX
MATTIFYING PRIME & SET

15 mL/ 0.5 FL OZ
30 mL/ 1.0 FL OZ
4 g/ 0.14 OZ

PRINCIPAL DISPLAY PANEL - Kit Carton
COVER FX MATTIFYING PRIME AND SET 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68327-072
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68327-072-011 in 1 CARTON06/01/201712/31/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 15 mL
Part 21 BOTTLE, SPRAY 30 mL
Part 31 JAR 4 g
Part 1 of 3
MATTIFYING PRIMER WITH ANTI-ACNE TREATMENT 
salicylic acid gel
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
BILBERRY (UNII: 9P2U39H18W)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
SQUALANE (UNII: GW89575KF9)  
PHENYL METHICONE (500 CST) (UNII: 5T0F958X3Z)  
SUGARCANE (UNII: 81H2R5AOH3)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)  
ORANGE (UNII: 5EVU04N5QU)  
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
LEMON (UNII: 24RS0A988O)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
ETHYL LINOLENATE (UNII: T54Y8H042V)  
ETHYL OLEATE (UNII: Z2Z439864Y)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SALIX NIGRA BARK (UNII: QU52J3A5B3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/01/2017
Part 2 of 3
MATTIFYING SETTING SPRAY 
face and neck (excluding shaving preparations)
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRKAOLIN (UNII: 24H4NWX5CO)  
INGRPOVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
INGRMETHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
INGRPPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRPOLOXAMER 407 (UNII: TUF2IVW3M2)  
INGRPEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGROLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/01/2017
Part 3 of 3
MATTE SETTING POWDER LIGHT 
face powders
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRMICA (UNII: V8A1AW0880)  
INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
INGRDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
INGRKAOLIN (UNII: 24H4NWX5CO)  
INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGRISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
INGRDEHYDROACETIC ACID (UNII: 2KAG279R6R)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRTETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
INGRFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
INGRPHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
INGRETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
INGRETHYL OLEATE (UNII: Z2Z439864Y)  
INGRFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/01/201712/31/2018
Labeler - Cover FX Skin Care Inc (202908021)

Revised: 12/2019
Document Id: 9a03e936-afe9-6dec-e053-2a95a90ad14a
Set id: 05efbc3b-814c-4001-89fe-8b3e3b30ed71
Version: 3
Effective Time: 20191218
 
Cover FX Skin Care Inc