CLEAR AND COVER ACNE TREATMENT CONCEALER CLEAR AND COVER ACNE TREATMENT CONCEALER 3 SHELL- salicylic acid cream 
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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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CLEAR AND COVER ACNE TREATMENT CREAM CONCEALER/CLEAR AND COVER ACNE TREATMENT CREAM CONCEALER 3 shell

Drug Facts

Active ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Use

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 reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Dimethicone, Trisiloxane, Kaolin, Polyisobutene, PEG/PPG-18/18 Dimethicone, Boron Nitride, Talc, Cyclodextrin, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, Trimethylsiloxysilicate, Phenoxyethanol, Bisabolol, Caprylyl Glycol, Glycerin, Triethoxycaprylylsilane, Tocopherol, Chamomilla Recutita (Matricaria) Flower Extract, Tocopheryl Acetate, Alumina, Silica, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate.
May Contain (+/-): Zinc Oxide (CI 77947), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491/CI 77492/CI 77499).

Package Labeling:

Outer PackageInner PackageShell

CLEAR AND COVER ACNE TREATMENT CONCEALER CLEAR AND COVER ACNE TREATMENT CONCEALER  3 SHELL
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31720-953
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
KAOLIN (UNII: 24H4NWX5CO)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
TALC (UNII: 7SEV7J4R1U)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LEVOMENOL (UNII: 24WE03BX2T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CHAMOMILE (UNII: FGL3685T2X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31720-953-181 in 1 BOX06/01/2020
13.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/01/2020
Labeler - S+ (572406531)

Revised: 12/2019
Document Id: 99820b99-64b3-998b-e053-2995a90a7fb5
Set id: d181de7a-6c44-462c-b75a-6f41e0443f5b
Version: 1
Effective Time: 20191212
 
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