X OUT SHINE CONTROL by Guthy-Renker LLC / Vee Pak Inc. X® OUT SHINE CONTROL

Drug Details [pdf]

X OUT SHINE CONTROL- salicylic acid cream
THE PROACTIV COMPANY LLC

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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X® OUT SHINE CONTROL

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 to once a day or every other day.

Inactive ingredients

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

Questions or comments?

Within US 1-800-524-7952

Dist. by: Guthy-Renker® LLC PO Box 14383 Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 20 mL Tube Box

X
OUT

SHINE CONTROL
OIL-FREE FORMULA

From the Makers of Proactiv®

salicylic acid treatment
0.75 FL. OZ. 20 mL

Principal Display Panel - 20 mL Tube Box

X OUT SHINE CONTROL
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-031
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Cyclomethicone 6 (UNII: XHK3U310BA)
Decylene Glycol (UNII: S57M60MI88)
10-Hydroxydecanoic Acid (UNII: NP03XO416B)
1,10-Decanediol (UNII: 5I577UDK52)
Sarcosine (UNII: Z711V88R5F)
Xanthan Gum (UNII: TTV12P4NEE)
Hexylene Glycol (UNII: KEH0A3F75J)
Edetate Disodium (UNII: 7FLD91C86K)
Caprylyl Glycol (UNII: 00YIU5438U)
Pentylene Glycol (UNII: 50C1307PZG)
Sebacic Acid (UNII: 97AN39ICTC)
Phenoxyethanol (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 11410-031-55	1 in 1 BOX	08/19/2013	12/02/2019
1		20 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	08/19/2013	12/02/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Name	Address	ID/FEI	Business Operations
Establishment
Vee Pak Inc.		874763303	MANUFACTURE(11410-031)

Revised: 1/2020

Document Id: 15bded9f-6b35-4bc1-a5ec-d6e2d007c95a

Set id: 0f15b808-c2a7-4d3a-bb7a-7330e0372f7d

Version: 2

Effective Time: 20200106