FDA.reportPublic FDA data

MINERAL SUNSCREEN SPF 50

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:25:53

Label at a glance#

ProductMINERAL SUNSCREEN SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 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 pro...

Storage and handling

protect this product in this container from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7.0%, Zinc Oxide 4.7%

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

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 if

OTC - STOP USE SECTION

  • 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 right away.

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

STORAGE AND HANDLING SECTION

  • protect this product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax, butyloctyl salicylate, caprylyl glycol, cetyl alcohol, euphorbia cerifera (candelilla) wax, isopropyl palmitate, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, silica

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topcare Everyday Mineral Sunscreen Stick SPF 50

NDC 36800-956-28

1.5 oz (42 g)

TOP48148EFTOP48148EF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-956-28MINERAL SUNSCREEN SPF 5042 g in 1 CONTAINERSTICK422

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-956MINERAL SUNSCREEN SPF 50 (ZINC OXIDE, TITANIUM DIOXIDE) STICK [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 1 package rows20241017_bfe076fa-f21f-2c46-e053-2a95a90acee4.zip

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
36800-95636800-956-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL PALMITATE8CRQ2TH63MIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETYL ALCOHOL936JST6JCNIACT
CANDELILLA WAXWL0328HX19IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
CERESINQ1LS2UJO3AIACT
WHITE WAX7G1J5DA97FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOSTEARIC ACIDX33R8U0062IACT
PARAFFINI9O0E3H2ZEIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
ndc (package): 36800-956-28
ndc (product): 36800-956
ndc11 (package): 36800095628
spl id: 2488439c-ee94-1236-e063-6294a90a4a7f
spl set id: bfe076fa-f21f-2c46-e053-2a95a90acee4

Reported adverse events (FAERS/openFDA)#

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