ELF Blemish Control Face Primer Clear by J. A. Cosmetics U.S. INC / Shanghai Tianle Chemicals Factory Drug Fact

ELF Blemish Control Face Primer Clear by

Drug Labeling and Warnings

ELF Blemish Control Face Primer Clear 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 BLEMISH CONTROL FACE PRIMER CLEAR- 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.

----------

Drug Fact

Active Ingredient:

Salicylic Acid 2.0%

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,  Hydrogenated Polyisobutene, Dimethicone, Butylene Glycol, Ethoxydiglycol, Propylene Glycol, Magnesium Aluminum Silicate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Tyiethanolamine, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, VP/Hexadecene Coplymer, Tocopheryl Acetate (VE), Stearic Acid, Xanthan Gum, Silica, Disodium EDTA, Panthenol, Rosmarinus Officinalis (Rosemary) Extract, Thymus Vulgaris (Thyme) Extract, Melaleuca Alternafolia (Tea Tree) Extract, Citrus Limon (Lemon) Peel Extract, Phenoxyethanol, Caprylyl Glycol

ELF BLEMISH CONTROL FACE PRIMER CLEAR 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-724
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
TROLAMINE HYDROCHLORIDE (UNII: R297UJ9QDY)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
DISODIUM HEDTA (UNII: KME849MC7A)
PANTHENOL (UNII: WV9CM0O67Z)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
THYMUS CITRIODORUS LEAF (UNII: 2J04LZ7UPZ)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-724-01	14 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/22/2016	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/22/2016	12/31/2018

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

Revised: 1/2016

Document Id: fff6bc0c-6a34-4f92-9b33-5e5a10bab75c

34390-5

Set id: 751416f2-a132-440d-b306-0d151af4f864

Version: 2

Effective Time: 20160122