FDA.reportPublic FDA data

BIG LOTS SOUNDBODY KIDS SUNSCREEN SPRAY SPF 50

Manufacturer
BIG LOTS STORES, INC.
Effective date
2024-10-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:26:27

Label at a glance#

ProductBIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Spray liberally and spread evenly by hand 15 minutres before sun exposure Hold can 4-6 inches away from the skin to apply Do not spray directly into face. Spray into hands then apply to face Do not apply in windy conditions Use in a well-ventilated area. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Children under 6 months of age: Ask a doctor Sun Protectio...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 4.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

FLAMMABLE:

WARNINGS AND PRECAUTIONS SECTION

  • do not use near heat, flame or while smoking
  • avoid long term storage above 104ºF (40ºC)

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.
  • keep away from face to avoid breathing it.
  • do not puncture or incinerate. Contents under pressure.
  • do not store at temperatures above 120ºF.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray liberally and spread evenly by hand 15 minutres before sun exposure
  • Hold can 4-6 inches away from the skin to apply
  • Do not spray directly into face. Spray into hands then apply to face
  • Do not apply in windy conditions

Use in a well-ventilated area.

Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Children under 6 months of age: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

  • protect the prodcut in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol (vitamin E), fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIG24416DBIG24416D

BIG24408DBIG24408D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50594-152-37BIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50156 g in 1 CANSPRAY1562
50594-152-48BIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50258 g in 1 CANSPRAY2582

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-152BIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [BIG LOTS STORES, INC.]2Current NDC, Legacy NDC, 2 package rows20241018_e4b70fdb-7548-175c-e053-2995a90adfe6.zip

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
50594-15250594-152-37, 50594-152-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
STEAROXYTRIMETHYLSILANE9862TW94B2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
BIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBIG LOTS STORES, INC.e4b70fdb-7548-175c-e053-2995a90adfe62024-10-16WarningsExact identifier
ndc (package): 50594-152-37
ndc (package): 50594-152-48
ndc (product): 50594-152
ndc11 (package): 50594015237
ndc11 (package): 50594015248
spl id: 249f5aec-1165-db1d-e063-6394a90a9619
spl set id: e4b70fdb-7548-175c-e053-2995a90adfe6

Reported adverse events (FAERS/openFDA)#

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