Topix Mineral Mattifying Tinted Sunscreen

Manufacturer
Topiderm, Inc. | Topix Pharmaceuticals, Inc.
Effective date
2023-02-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:27

Label at a glance#

ProductTopix Mineral Mattifying Tinted Sunscreen SPF 50
Active ingredientZINC OXIDE
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 and spread evenly by hand 15 minutes before sun exposure Re-apply after swimming, excessive perspiring, or anytime after towel drying Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.5%

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.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes, rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.
  • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

  • 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 and other sunscreen measures including:
    • limit time in the sun, especially from 10a.m.-2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and spread evenly by hand 15 minutes before sun exposure
  • Re-apply after swimming, excessive perspiring, or anytime after towel drying
  • Use a water resistant sunscreen if swimming or sweating
  • Use on children under 6 months of age: consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ascorbic Acid, Biotin, Camellia Sinensis (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Centella Asiatica Extract, Ceramide NG, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone, Glycerin, Hexyl Laurate, Iron Oxides, Isododecane, Methyl Trimethicone, PEG/PPG-18/18 Dimethicone, PEG-10 Dimethicone, PEG-8 Methyl Ether Triethoxysilane, Phospholipids, Phyllanthus Emblica Fruit Extract, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Purified Water, Resveratrol, Silica Dimethyl Silylate, Silica, Stearic Acid, Titanium Dioxide, Tocopheryl Acetate, Ubiquinone (Co-Enzyme Q10).

PRINCIPAL DISPLAY PANEL - 54 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

MULTI-TASKING

Mineral Mattifying
Tinted Sunscreen
SPF 50

Broad Spectrum SPF 50

Net wt. 1.9 oz. (54 g)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

PRINCIPAL DISPLAY PANEL - 54 g Bottle Label
PRINCIPAL DISPLAY PANEL - 54 g Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-137-01Topix Mineral Mattifying Tinted Sunscreen SPF 5054 g in 1 BOTTLELOTION543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-137TOPIX MINERAL MATTIFYING TINTED SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [TOPIDERM, INC.]3Current NDC, 1 package rows20231031_ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e91.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-13751326-137-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 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
Topix Mineral Mattifying Tinted Sunscreen SPF 50ZINC OXIDETopiderm, Inc.ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e912023-02-22WarningsExact identifier
ndc (package): 51326-137-01
ndc (product): 51326-137
ndc11 (package): 51326013701
spl id: f4ba7fdd-7b54-4bac-991c-0d91181a6f20
spl set id: ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e91

Reported adverse events (FAERS/openFDA)#

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