Skip to Content

Cover FX Mattifying Prime and Set

Medically reviewed on May 22, 2017

Dosage form: kit
Ingredients: Salicylic Acid 10mg in 1mL;
Labeler: Cover FX Skin Care Inc
NDC Code: 68327-072

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.

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

Established Pharmacological Class
SubstancePharmacological Class
Mattifying Setting SprayFACE AND NECK (EXCLUDING SHAVING PREPARATIONS)
Matte Setting Powder LightFACE POWDERS
COVER FX MATTIFYING PRIME AND SET 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68327-072
Packaging
#Item CodePackage Description
1NDC:68327-072-011 KIT in 1 CARTON
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) 
BIS-PEG/PPG-14/14 DIMETHICONE 
BILBERRY 
GLYCERIN 
DIMETHICONE 
MEDIUM-CHAIN TRIGLYCERIDES 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 
SQUALANE 
PHENYL METHICONE (500 CST) 
SUGARCANE 
.ALPHA.-BISABOLOL, (+)- 
CAPRYLYL GLYCOL 
TOCOPHEROL 
DIMETHICONOL (40 CST) 
PHENOXYETHANOL 
PEG-60 ALMOND GLYCERIDES 
ACER SACCHARUM BARK/SAP 
ORANGE 
ANNICKIA CHLORANTHA BARK 
LEMON 
PHYTOSPHINGOSINE 
TETRAHEXYLDECYL ASCORBATE 
ETHYL LINOLEATE 
ETHYL LINOLENATE 
ETHYL OLEATE 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
SILICON DIOXIDE 
POLYSORBATE 20 
OLEANOLIC ACID 
MASOPROCOL 
PALMITOYL HEXAPEPTIDE-12 
PALMITOYL TETRAPEPTIDE-7 
CYCLOMETHICONE 5 
SALIX NIGRA BARK 
Packaging
#Item CodePackage Description
115 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/01/2017
Part 2 of 3
MATTIFYING SETTING SPRAY 
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
WATER 
BUTYLENE GLYCOL 
kaolin 
POVIDONE, UNSPECIFIED 
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER 
PPG-3 Benzyl Ether Myristate 
Phenoxyethanol 
caprylyl glycol 
Poloxamer 407 
PEG-10 DIMETHICONE (600 CST) 
Ethylhexylglycerin 
ANNICKIA CHLORANTHA BARK 
Sodium Hydroxide 
Oleanolic Acid 
Packaging
#Item CodePackage Description
130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/01/2017
Part 3 of 3
MATTE SETTING POWDER LIGHT 
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Mica 
SILICON DIOXIDE 
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) 
kaolin 
GREEN TEA LEAF 
isostearyl neopentanoate 
dehydroacetic acid 
tocopherol 
tetrahexyldecyl ascorbate 
FERRIC OXIDE YELLOW 
phytosphingosine 
ethyl linoleate 
ethyl oleate 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
14 g in 1 JAR
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 finalpart333D06/01/2017
Labeler - Cover FX Skin Care Inc (202908021)
Establishment
NameAddressID/FEIOperations
Cover FX Skin Care Inc202908021MANUFACTURE(68327-072)

 
Cover FX Skin Care Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide