Topix Mineral Brightening and Correcting Eye Make-up

Manufacturer
Topiderm, Inc.
Effective date
2023-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:40

Label at a glance#

ProductTopix Mineral Brightening and Correcting Eye Make-up SPF 50
Active ingredientZINC OXIDE, TITANIUM 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 at least every 2 hours 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 of 15 or higher & other sunscreen measures including: Limit time in the sun especially from 10 a.m. to 2 p.m. Wear long-sleeve shirts, pants, hats, and sungl...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Zinc Oxide 6.5%Sunscreen
Titanium Oxide 6.4%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

SPL UNCLASSIFIED SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center Immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • 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 of 15 or higher & other sunscreen measures including:
    • Limit time in the sun especially from 10 a.m. to 2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months of age: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Caprylyl Methicone, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Dimethicone Crosspolymer, Glycerin, Isododecane, Dimethicone, Alumina, Hydrogen Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides, Tin Oxide, Sodium Hyaluronate, Acetyl Hexapeptide-8, Leontopodium Alpinum Callus Culture Extract, Dunaliella Salina Extract, Macrocystis Pyrifera (Kelp) Extract, Panthenol, Tocopheryl Acetate, Palmitoyl Tripeptide-5, Hydrolyzed Vegetable Protein, Ascophyllum Nodosum Extract, Asparagopsis Armata Extract, Sucrose, Xanthan Gum, Mica, Silica, PVP, Triethoxycaprylylsilane, Sorbitol, Phenyl Trimethicone, Sodium Chloride, Phenoxyethanol, Disodium EDTA, Potassium Sorbate.

PRINCIPAL DISPLAY PANEL - 8.5 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AGE DEFENSE
FOR THE EYES

5-IN-1

BROAD SPECTRUM UVA/UVB SPF 50+

WATER/SWEAT RESISTANT (80 MIN)

Net 0.29 fl. oz. (8.5 ml)

Principal Display Panel - 8.5 ml Tube Carton
Principal Display Panel - 8.5 ml Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51326-121-012025-01-30C16284748780-12cef2736-b3b0-d83d-e063-dadaa90ab31fTopix Mineral Brightening and Correcting Eye Make-up SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-121-01Topix Mineral Brightening and Correcting Eye Make-up SPF 508.5 mL in 1 TUBELOTION8.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-121TOPIX MINERAL BRIGHTENING AND CORRECTING EYE MAKE-UP SPF 50 (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [TOPIDERM, INC.]11 package rows20230411_a0b04863-3054-46d4-be1d-ef2d32906675.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-12151326-121-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

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
0455d937-704b-47e1-8ca5-2925ab973f8ca0b04863-3054-46d4-be1d-ef2d329066752023-03-17WarningsExact identifier
spl id: 0455d937-704b-47e1-8ca5-2925ab973f8c
spl set id: a0b04863-3054-46d4-be1d-ef2d32906675

Reported adverse events (FAERS/openFDA)#

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