FDA.reportPublic FDA data

Sound Body

Manufacturer
Big Lots Stores, Inc.
Effective date
2016-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:05

Label at a glance#

ProductSound Body
Active ingredientSALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Salicylic Acid 2.0%

OTC - PURPOSE SECTION

Purpose

Acne Treatment

INDICATIONS & USAGE SECTION

Uses   -for the treatment of acne   -clears blackheads

WARNINGS SECTION

Warnings

For external use only

When using this product

-skin irritation and dryness is more likely to occur if you use

another topical acne medication at the same time. If irritation

occurs, only use one topical acen medication at a time.

Avoid contact with eyes. If contact occurs, flush thoroughly

with water.

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.

DOSAGE & ADMINISTRATION SECTION

Directions  -wet face  -gently massage over face for 20-30

seconds, avoiding eye area  -rinse thoroughly and pat dry

-recommended for daily use.

INACTIVE INGREDIENT SECTION

Inactive ingredients  water, cetyl alcohol, PPG-15 stearyl ether,

hydrogenated castor oil, microcrystalline wax, potassium

cetyl phosphate, steareth-21, polysorbate 60, carnauba (copernicia cerifera)

wax, xantham gum, fragrance, menthyl lactate, blue 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50594-52950594-529-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
PPG-15 STEARYL ETHER1II18XLS1LIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
STEARETH-2153J3F32P58IACT
POLYSORBATE 60CAL22UVI4MIACT
CARNAUBA WAXR12CBM0EIZIACT
XANTHAN GUMTTV12P4NEEIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
2e7c6282-7a76-4717-a77f-26fb1b9138f814abef52-b30f-4554-a7ec-95983ae0193c2016-05-09WarningsExact identifier
spl id: 2e7c6282-7a76-4717-a77f-26fb1b9138f8
spl set id: 14abef52-b30f-4554-a7ec-95983ae0193c

Reported adverse events (FAERS/openFDA)#

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