FDA.reportPublic FDA data

Signature SPF 50 Tinted Face

Manufacturer
Sun Bum LLC
Effective date
2022-03-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:53

Label at a glance#

ProductSignature SPF 50 Tinted Face
Active ingredientTITANIUM DIOXIDE
Label structure8 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

Apply liberally 15 minutes before sun exposure 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 pr...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 20.8%

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

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.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • 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

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

aluminum hydroxide, butyloctyl salicylate, C12-15 alkyl benzoate, caprylyl methicone, copernicia cerifera (carnauba) wax, dimethicone, hydrogenated polydecane, iron oxides (CI 77491 CI 77492, CI 77499), isostearic acid, kaolin, methyl methacrylate crosspolymer, microcrystalline wax, phytosteryl/behynyl/octyldodecyl lauroyl glutamate, polyethylene, tocopheryl acetate

Questions?

OTC - QUESTIONS SECTION

1 (877) 978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-609-012025-01-30C16284748780-1d6a99b39-ee0d-a426-e053-dadaa90af4c2Signature SPF 50 Tinted Face Stick
69039-609-012022-03-22C16284748780-1d6a99b39-ee0d-a426-e053-dadaa90af4c2Signature SPF 50 Tinted Face Stick
69039-609-012022-01-28C16284748780-1d6a99b39-ee0d-a426-e053-dadaa90af4c2Signature SPF 50 Tinted Face Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-609-01Signature SPF 50 Tinted Face1 in 1 BOXSTICK12
69039-609-01Signature SPF 50 Tinted Face13 g in 1 CARTRIDGESTICK132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-609SIGNATURE SPF 50 TINTED FACE (TITANIUM DIOXIDE) STICK [SUN BUM LLC]2Legacy NDC, 2 package rows20220323_65ce8864-e185-42f3-bac8-0d9faeaec88c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-60969039-609-01

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
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CARNAUBA WAXR12CBM0EIZIACT
DIMETHICONE92RU3N3Y1OIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ISOSTEARIC ACIDX33R8U0062IACT
KAOLIN24H4NWX5COIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
dad0dcb7-36e8-ee68-e053-2a95a90a406065ce8864-e185-42f3-bac8-0d9faeaec88c2022-03-22WarningsExact identifier
spl id: dad0dcb7-36e8-ee68-e053-2a95a90a4060
spl set id: 65ce8864-e185-42f3-bac8-0d9faeaec88c

Reported adverse events (FAERS/openFDA)#

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