X OUT SHINE CONTROL- salicylic acid gel

X Out Shine Control by

Drug Labeling and Warnings

X Out Shine Control by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

When using this product

• skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only  use one topical acne medication at a time.
• avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• cleanse the skin thoroughly before applying this product.
• cover the entire affected area with a thin layer one to three times daily.
• because excessive drying of the 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 once a day or every other day.

Inactive Ingredients

water, alcohol denat., butylene glycol, cyclopentasiloxane, glyceryl stearate, PEG-100 stearate, nylon-12, cyclohexasiloxane, PVM/MA decadiene crosspolymer,  decylene glycol, sodium hydroxide, caprylyl glycol,  hexylene glycol, aluminum starch octenylsuccinate, disodium EDTA, sarcosine, pentylene glycol, xanthan gum, 10-hydroxydecanoic acid,sebacic acid, 1,10-decanediol,  phenoxyethanol, fragrance

Questions or comments?
Within US 1-800-524-7952

PRINCIPAL DISPLAY PANEL - 50 mL Carton

X OUT

SHINE CONTROL
OIL-FREE FORMULA 
From the Makers of Proactiv®               

 1.7 FL. OZ. · 50 mL

salicylic acid acne treatment

Dist. by: The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
XOut.com ● Make in the USA of Foreign and Domestic Components
X Out is a trademark of The Proactiv Company Sàrl.

INGREDIENTS AND APPEARANCE

X OUT SHINE CONTROL 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-037
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
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Butylene Glycol (UNII: 3XUS85K0RA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Nylon-12 (UNII: 446U8J075B)
Cyclomethicone 6 (UNII: XHK3U310BA)
Decylene Glycol (UNII: S57M60MI88)
Sodium Hydroxide (UNII: 55X04QC32I)
Caprylyl Glycol (UNII: 00YIU5438U)
Hexylene Glycol (UNII: KEH0A3F75J)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Sarcosine (UNII: Z711V88R5F)
Pentylene Glycol (UNII: 50C1307PZG)
Xanthan Gum (UNII: TTV12P4NEE)
10-hydroxydecanoic Acid (UNII: NP03XO416B)
Sebacic Acid (UNII: 97AN39ICTC)
1,10-decanediol (UNII: 5I577UDK52)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-037-17	1 in 1 CARTON	10/12/2017
1		50 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	part333D	10/12/2017

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-037)