FDA.reportPublic FDA data

Be Smart Get Prepared Sunscreen

Manufacturer
Total Resources International Inc.
Effective date
2022-11-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:52:53

Label at a glance#

ProductBe Smart Get Prepared Sunscreen
Active ingredientOCTISALATE, OXYBENZONE, HOMOSALATE, OCTINOXATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Homosalate (6.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (5.0%)....................Sunscreens

OTC - PURPOSE SECTION

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn

WARNINGS SECTION

Skin cancer/skin aging alert: spending time in the sun increases your risk of skin cancer and early skin aging.This product has been shown only to prevent sunburn, not skin cancer or early aging skin.

For external use only.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • rash occurs.

OTC - DO NOT USE SECTION

Do not use • on damaged or broken skin.

OTC - STOP USE SECTION

Stop use, ask a doctor if

  • rash occurs

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.

INDICATIONS & USAGE SECTION

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months: ask a doctor

OTHER SAFETY INFORMATION

Other Information

  • protect this product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients

cetyl alcohol, ganex P-904, germaben II, petrolatum, polyoxyl 40 stearate, polysorbate 60, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Be Smart Get PreparedBe Smart Get Prepared

Be Smart Get PreparedBe Smart Get Prepared

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55550-950-022024-01-30C16284748780-11030e365-68b2-111a-e063-dadaa90a10e2Be Smart Get Prepared Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55550-950-02Be Smart Get Prepared Sunscreen1.5 g in 1 POUCHOINTMENT1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55550-950BE SMART GET PREPARED SUNSCREEN (SUNSCREEN) OINTMENT [TOTAL RESOURCES INTERNATIONAL INC.]1Legacy NDC, 1 package rows20230101_ee030fb7-230f-09b9-e053-2995a90a9133.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55550-95055550-950-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 60CAL22UVI4MIACT
XANTHAN GUMTTV12P4NEEIACT
POVIDONE K30U725QWY32XIACT
DIMETHICONE92RU3N3Y1OIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
EDETATE SODIUMMP1J8420LUIACT
CETYL ALCOHOL936JST6JCNIACT
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PETROLATUM4T6H12BN9UIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT

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
ee030fb7-2310-09b9-e053-2995a90a9133ee030fb7-230f-09b9-e053-2995a90a91332022-11-22WarningsExact identifier
spl id: ee030fb7-2310-09b9-e053-2995a90a9133
spl set id: ee030fb7-230f-09b9-e053-2995a90a9133

Reported adverse events (FAERS/openFDA)#

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