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ELF Caramel ACNE Fighting Foundation

Medically reviewed on October 17, 2017

Dosage form: cream
Ingredients: SALICYLIC ACID 0.5g in 100mL
Labeler: J. A. Cosmetics U.S. INC
NDC Code: 76354-605

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.

Drug Fact

Active Ingredient:


Salicylic Acid 0.5%

Purpose:

Acne Treatment

Uses:

For the 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.

Skin irrittion and dryness is more likely to occur if you use another topical acne medications at the same time.  If irritation occurs, only use one medication at a time.

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. Because excessive drying of skin may occur, start with one application daily, then gradually increase to two or three times daily 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 Ingredient:

Water,  Cyclopentasiloxane, Hydrogenated Polyisobutene, Ethoxydiglycol, Dimethicone, Cyclohexasiloxane, Dimethicone Crossploymer, PEG-10 Dimethicone, Dimethicone PEG 10/15 Crosspolymer, Magnesium Sulfate, Talc, Nylon-12, Phenoxyethanol, Propylene Glycol, Quaternium-18 Benonite, Triethoxycaprylysilane, Methylparaben, Ethylparaben, butylparaben, Propylparaben, Isobutylparaben, Cinnamomum Camphora (Camphor) Bark oil, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Jiuce, Hexapeptide-9, Hamamelis Birginiana (Witch Hazel)

May Contain:

Iron Oxide (CI77491, CI77492, CI77499), Titanium Dioxide

ELF CARAMEL ACNE FIGHTING FOUNDATION 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-605
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
HYDROGENATED POLYBUTENE (1300 MW) 
WATER 
DIMETHICONE 
CAMPHOR OIL 
DIMETHICONE PEG-10 PHOSPHATE 
PROPYLENE GLYCOL 
NYLON-12 
TALC 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
MAGNESIUM SULFATE 
TRIETHOXYCAPRYLYLSILANE 
METHYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
ISOBUTYLPARABEN 
TEA TREE OIL 
ALOE VERA LEAF 
WITCH HAZEL 
Packaging
#Item CodePackage Description
1NDC:76354-605-0136 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/09/2015
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
Establishment
NameAddressID/FEIOperations
Hangzhou Facecare Cosmetics Co., Ltd.545341856manufacture(76354-605)

 
J. A. Cosmetics U.S. INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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