FDA.reportPublic FDA data

Topix Mineral Finishing Sunscreen

Manufacturer
Topiderm, Inc | Topiderm, Inc. | Aopline Health Industry Technology (Guangzhou) Co., Ltd.
Effective date
2024-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:19

Label at a glance#

ProductTopix Mineral Finishing Sunscreen SPF 30
Active ingredientZINC OXIDE
Label structure9 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 10a.m.-2p.m. Wear long-sleeve shirts, pants, hats, & sunglasses C...

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

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24.7%

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 - 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 10a.m.-2p.m. Wear long-sleeve shirts, pants, hats, & 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

Silica, Mica, Polymethyl Methacrylate, Ascorbic Acid (Vitamin C), Ceramide EOP, Sodium Hyaluronate (Hyaluronic Acid), Tocopherol (Vitamin E), Camellia Sinensis Leaf Extract, CI 77492, CI 77491

PRINCIPAL DISPLAY PANEL - 5 g Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MINERAL POWDER

BRUSH-ON
SUNSCREEN
SPF
30

SUN PROTECTION
+ OIL CONTROL

Protects against visible aging
Sets makeup and reduces shine
Translucent color blurs imperfections

BROAD SPECTRUM SPF 30

Net 0.16 oz. (5 g)

PRINCIPAL DISPLAY PANEL - 5 g Bottle Box
PRINCIPAL DISPLAY PANEL - 5 g Bottle Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-206-01Topix Mineral Finishing SunscreenSPF 301 in 1 BOXPOWDER11
51326-206-01Topix Mineral Finishing SunscreenSPF 305 g in 1 BOTTLE, WITH APPLICATORPOWDER51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-206TOPIX MINERAL FINISHING SUNSCREEN SPF 30 (ZINC OXIDE) POWDER [TOPIDERM, INC]12 package rows20240423_db7375dc-cbe5-4111-b5b3-085cae80d7bf.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-20651326-206-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MICAV8A1AW0880IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CERAMIDE 15THT33P7X7IACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT

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
667cd8f6-a70c-414b-b523-017e28ecdb43db7375dc-cbe5-4111-b5b3-085cae80d7bf2024-04-18WarningsExact identifier
spl id: 667cd8f6-a70c-414b-b523-017e28ecdb43
spl set id: db7375dc-cbe5-4111-b5b3-085cae80d7bf

Reported adverse events (FAERS/openFDA)#

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