FDA.reportPublic FDA data

Titanium Dioxide

Manufacturer
EAI-JR 286, Inc.
Effective date
2025-10-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:42:42

Label at a glance#

ProductVertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige
Active ingredientTITANIUM DIOXIDE
Label structure9 sections

Storage and handling

Protect this product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 23%..............Sunscreen

OTC - PURPOSE 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.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes activity in the water, sweating or perspiring.
  • Provides high protection against sunburn.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if:

  • Rash or irritation develops and lasts.

WARNINGS SECTION

Do not use:

  • On damaged or broken skin

When using this product:

  • Keep out of eyes. Rinse with water to remove.

For external use only.

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and generously 15 minutes before sun exposure and 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 your time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours

INACTIVE INGREDIENT SECTION

Hexyldecyl Isostearate, Aluminum Hydroxide, Mica, Iron Oxides, Stearic Acid, Paraffin, Ozokerite, Synthetic Wax, Ethylene/Propylene Copolymer, Polyglyceryl-2 Oleate, Tocopherol, Stearyl Glycyrrhetinate, Fragrance

STORAGE AND HANDLING SECTION

Protect this product in this container from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

vertra

35

Coolangatta Beige Face Stick

Mineral Based Foundation

Broad Spectrum SPF35

Water Resistant (80 Minutes)

11g NET WT. 0.39 OZ

Coolangatta beige Face stick BoxCoolangatta beige Face stick Box

Cap SPF 35 coolangataCap SPF 35 coolangata

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130889297004461GTIN-13: 0889297004461
EAN-13: 0889297004461
GTIN-12: 889297004461
UPC-A: 889297004461
GTIN storage (14 digits): 00889297004461		PKG_10003069_COOLANGATTA BEIGE FACE STICK SPF 35_MICK FANNING_RPAC_BOX.R02_OL_250717.jpg
QR code linkQR Codewww.vertra.com/PKG_10003069_COOLANGATTA BEIGE FACE STICK SPF 35_MICK FANNING_RPAC_BOX.R02_OL_250717.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71014-090-012023-05-25C16284748780-1f386c64a-3146-0266-e053-dadaa90a7c1aVertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige
71014-090-012023-05-25C16284748780-1f386c64a-3146-0266-e053-dadaa90a7c1aVertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige
71014-090-012023-01-30C16284748780-1f386c64a-3146-0266-e053-dadaa90a7c1aVertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige
71014-090-012023-01-30C16284748780-1f386c64a-3146-0266-e053-dadaa90a7c1aVertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71014-090-01Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige11 g in 1 CARTONSTICK114

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71014-09071014-090-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675IACT
POLYGLYCERYL-2 OLEATE5759J47SAMIACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
HEXYLDECYL ISOSTEARATE3V20TC06U5IACT
MICAV8A1AW0880IACT
STEARIC ACID4ELV7Z65APIACT
CERESINQ1LS2UJO3AIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PARAFFINI9O0E3H2ZEIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-10-22full-release2026-06-01 00:28:36

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
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
ndc (package): 71014-090-01
ndc (product): 71014-090
ndc11 (package): 71014009001
spl id: 409764bb-eb52-f5c0-e063-6394a90a8ee4
spl set id: b9ea12e8-6ed9-d805-e053-2a95a90aa107

Reported adverse events (FAERS/openFDA)#

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