ELF CARAMEL ACNE FIGHTING FOUNDATION- salicylic acid cream

ELF Caramel ACNE Fighting Foundation by

Drug Labeling and Warnings

ELF Caramel ACNE Fighting Foundation by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Hangzhou Facecare Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Salicylic Acid 0.5%

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,  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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELF CARAMEL ACNE FIGHTING FOUNDATION 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-605
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 (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: 76354-605-01	36 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

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

Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Facecare Cosmetics Co., Ltd.		545341856	manufacture(76354-605)