FDA.reportPublic FDA data

spf 50 mineral powder sunscreen

Manufacturer
Smalls Brand LLC DBA Roe Wellness
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:52:26

Label at a glance#

Productspf 50 mineral powder sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Titanium DIoxide 23.9%

Zinc Oxide 24.1 %

Purpose: Sunscreen

OTC - PURPOSE SECTION

Uses:

  • Helps prevent sunburn

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 right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warning:

  • For external use only. Do not use on broken or damaged skin
  • When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply liberally 15 minutes before sun or water exposure. Works best on moisturized skin. Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

roe wellness

spf 50 mineral powder

borad spectrum

0.21 oz 6g

spf powder cartonspf powder carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850038901059GTIN-13: 0850038901059
EAN-13: 0850038901059
GTIN-12: 850038901059
UPC-A: 850038901059
GTIN storage (14 digits): 00850038901059		spf powder carton 12.16.22 (1).jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83369-001-01spf 50 mineral powder sunscreen6 g in 1 CARTONPOWDER65

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83369-00183369-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICAV8A1AW0880IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CERAMIDE 15THT33P7X7IACT
TOCOPHEROLR0ZB2556P8IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
HYALURONATE SODIUMYSE9PPT4THIACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIB
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-02-19monthly-update2026-06-03 17:58:08

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
spf 50 mineral powder sunscreenTITANIUM DIOXIDE, ZINC OXIDESmalls Brand LLC DBA Roe Wellnessf8762dd1-0484-74ea-e053-6294a90ac1122026-03-31WarningsExact identifier
ndc (package): 83369-001-01
ndc (product): 83369-001
ndc11 (package): 83369000101
spl id: 4e572d00-4ae1-e800-e063-6294a90a1076
spl set id: f8762dd1-0484-74ea-e053-6294a90ac112

Reported adverse events (FAERS/openFDA)#

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