ELF ACNE Fighting Foundation by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD. Drug Fact

Drug Details [pdf]

ELF 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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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.

With other tropical acne medications at the same time or immediately following use of this product may increase dryness or irritation to the skin. If this occurs, only one medication should be used unless directed by your 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. 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.

Other Information:

Protect the product in its container from excessive heat and direct sun.

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

lab label

ELF ACNE FIGHTING FOUNDATION
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-019
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 76354-019-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2013	12/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	03/09/2013	12/31/2017

Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 3/2013

Document Id: 888158e0-01f4-412e-9468-fe15549c2d01

Set id: 8d5f0da7-c6f3-44e9-b3ba-62be771fbe94

Version: 2

Effective Time: 20130309

J. A. Cosmetics U.S. INC