ELF ACNE Fighting Foundation Buff by J. A. Cosmetics U.S. INC / Shanghai Tianle Chemicals Factory Drug Fact

ELF ACNE Fighting Foundation Buff by

Drug Labeling and Warnings

ELF ACNE Fighting Foundation Buff by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai Tianle Chemicals Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF ACNE FIGHTING FOUNDATION BUFF- 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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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

label

ELF ACNE FIGHTING FOUNDATION BUFF 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76354-702
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAMPHOR OIL (UNII: 75IZZ8Y727)  
DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NYLON-12 (UNII: 446U8J075B)  
TALC (UNII: 7SEV7J4R1U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
TEA TREE OIL (UNII: VIF565UC2G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WITCH HAZEL (UNII: 101I4J0U34)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76354-702-0136 mL in 1 BOTTLE; Type 0: Not a Combination Product08/09/201512/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/09/201512/31/2018
Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 8/2015
 
J. A. Cosmetics U.S. INC