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

ELF ACNE Fighting Foundation Sand by

Drug Labeling and Warnings

ELF ACNE Fighting Foundation Sand 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 SAND- 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

ELF ACNE FIGHTING FOUNDATION SAND 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-704
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-704-01	36 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/09/2015	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/09/2015	12/31/2018

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

Revised: 8/2015

Document Id: 2d28bbc4-f6a3-4f41-8e4e-5c55bc1e64df

34390-5

Set id: c08055cb-2339-4702-8ea3-b178e03a0e21

Version: 2

Effective Time: 20150813

 

J. A. Cosmetics U.S. INC