ELF CLEAR BLEMISH CONTROL FACE PRIMER- salicylic acid cream

ELF Clear Blemish Control Face Primer by

Drug Labeling and Warnings

ELF Clear Blemish Control Face Primer by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc, Zhejiang Ayan Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Salicylic Acid 2.0%

PURPOSE

Purpose:

Acne Treatment

INDICATIONS & USAGE

Uses:

For the treatment of acne

Helps prevent new acne blemishes

WARNINGS

Warning:

For external use only

WHEN USING

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.

ASK DOCTOR

Stop use and ask a doctor If

rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children

DOSAGE & ADMINISTRATION

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELF CLEAR BLEMISH CONTROL FACE PRIMER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-624
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 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)
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: 76354-624-01	14 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/10/2015

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

Registrant - Zhejiang Ayan Biotech Co.,Ltd. (544377996)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ayan Biotech Co.,Ltd.		544377996	manufacture(76354-624)