ACNE FIGHTING FOUNDATION- salicylic acid cream 
J. A. Cosmetics U.S. 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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Active Ingredient:

SALICYLIC ACID 2%

Purpose:

ACNE TREATMENT

Uses:

  • FOR TREATMENT OF ACNE 
  • HELPS PREVENT NEW ACNE BLEMISHES

Warning:

For external use only

When Using This Product

  • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
  • WITH OTHER TROPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF SKIN. IF OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Stop use and ask a doctor if

  • rash occurs.

KEEP OUT OF REACH OF CHILDREN.

Directions:

  • CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION. COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY. BEACAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THE GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESSOR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.

Inactive Ingredient:

WATER (AQUA), CYCLOPENTASILOXANE, HYDROGENATED POLYISBUTENE, ETHOXYDIGLYCOL, DIMETHICONE, CYCLOHEXASILOXANE, DIMETHICONE CROSSPOLYMER, PEG-10 DIMETHICONE, DIMETHICONE/PEG-10/15 CROSSPLOYMER, PROPYLENE GLYCOL, NYLON-12, TALC, PHENOXYETHANOL, QUATERNIUM 18 BENTONITE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, CINNAMOMUM CAMPHORA (CAMPHOR) BARK OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, ALOE BARBADENSIS LEAF JUICE, HEXAPEPTIDE-9, HAMAMELIS VIRGINIANA (WHICH HAZEL) WATER

MAY CONTAIN: IRON OXIDES (CL 77491, CL 77492, CL 77499) TIANIUM DIOXIDE (CL 77891)

Acne Foundation_single shade CARTON

Acne foundation_single shade TUBE

ACNE FIGHTING FOUNDATION 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76354-203
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
HYDROGENATED POLYBUTENE (1300 MW) 
DIETHYLENE GLYCOL MONOETHYL ETHER 
DIMETHICONE 
CYCLOMETHICONE 6 
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER 
PEG-10 DIMETHICONE (600 CST) 
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) 
PROPYLENE GLYCOL 
NYLON-12 
TALC 
PHENOXYETHANOL 
BENTOQUATAM 
MAGNESIUM SULFATE 
TRIETHOXYCAPRYLYLSILANE 
METHYLPARABEN 
ETHYLPARABEN 
BUTYLPARABEN 
PROPYLPARABEN 
ISOBUTYLPARABEN 
CINNAMOMUM CAMPHORA WHOLE 
MELALEUCA ALTERNIFOLIA LEAF 
ALOE VERA LEAF 
ACETYL HEXAPEPTIDE-8 
HAMAMELIS VIRGINIANA TOP WATER 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERRIC OXYHYDROXIDE 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-203-511 in 1 BOX
1NDC:76354-203-1136 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/02/2014
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai J. A. Cosmetics Trading CO., LTD.421280183manufacture(76354-203)

Revised: 2/2014
 
J. A. Cosmetics U.S. INC