FDA.reportPublic FDA data

X Out Shine Control

Manufacturer
THE PROACTIV COMPANY LLC | VEE PAK, LLC
Effective date
2018-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:03:38

Label at a glance#

ProductX Out Shine Control
Active ingredientSalicylic Acid
Label structure8 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the management of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation becomes severe.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

50mL Carton
50mL Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-03711410-037-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Water059QF0KO0RIACT
Alcohol3K9958V90MIACT
Butylene Glycol3XUS85K0RAIACT
Cyclomethicone 50THT5PCI0RIACT
Glyceryl Monostearate230OU9XXE4IACT
Peg-100 StearateYD01N1999RIACT
Nylon-12446U8J075BIACT
Cyclomethicone 6XHK3U310BAIACT
Decylene GlycolS57M60MI88IACT
Sodium Hydroxide55X04QC32IIACT
Caprylyl Glycol00YIU5438UIACT
Hexylene GlycolKEH0A3F75JIACT
Aluminum Starch OctenylsuccinateI9PJ0O6294IACT
Edetate Disodium Anhydrous8NLQ36F6MMIACT
SarcosineZ711V88R5FIACT
Pentylene Glycol50C1307PZGIACT
Xanthan GumTTV12P4NEEIACT
10-hydroxydecanoic AcidNP03XO416BIACT
Sebacic Acid97AN39ICTCIACT
1,10-decanediol5I577UDK52IACT
PhenoxyethanolHIE492ZZ3TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d09b1564-fd74-4997-9c19-1bd3db3d12d73cec7f65-6637-4ddc-9f2c-15a36fd7a1592022-12-22WarningsExact identifier
spl set id: 3cec7f65-6637-4ddc-9f2c-15a36fd7a159

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.