FDA.reportPublic FDA data

Titanium Dioxide and Zinc Oxide

Manufacturer
Small World Brands
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:48:31

Label at a glance#

ProductNuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure10 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

For sunscreen use: Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating 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 and other sun protection measures including: Limit time in the sun...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Titanium Dioxide 1.65%Sunscreen
Zinc Oxide 11.0%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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For sunscreen use:
    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • 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 and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, caprylic / capric triglyceride, glycerin, sorbitan laurate, isostearyl isostearate, polyglyceryl-4 laurate / succinate, decyl isostearate, citric acid, magnesium aluminum silicate, magnolia biondii bud / flower extract, melissa officinalis leaf extract, prunus persica flower extract, euphrasia officinalis extract, xanthan gum, aluminum stearate, alumina, isostearic acid, lecithin, butylene glycol, polyhydroxystearic acid, sodium benzoate, ethylhexylglycerin, phenoxyethanol

Questions?

OTC - QUESTIONS SECTION

Call toll-free (888) 620-6818 or direct (609) 469-3349 from 8 a.m. - 6 p.m. EST Monday - Friday

SPL UNCLASSIFIED SECTION

Distr. by :
Small World Brands
Princeton, NJ 08540

PRINCIPAL DISPLAY PANEL - 25 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nuria™

Defend
Matte Finish
Daily Moisturizer
Mineral Sunscreen
Broad Spectrum SPF 30

with Peach Flower
native to China

25 mL / 0.8 fl oz

PRINCIPAL DISPLAY PANEL - 25 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 25 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78611-4146-12022-01-31C16284748780-1d6a99b39-4c6b-a426-e053-dadaa90af4c2Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30
78611-4146-12022-01-28C16284748780-1d6a99b39-4c6b-a426-e053-dadaa90af4c2Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78611-4146-1Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION14
78611-4146-1Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 3025 mL in 1 BOTTLELOTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78611-4146NURIA DEFEND MATTE FINISH DAILY MOISTURIZER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SMALL WORLD BRANDS]4Current NDC, Legacy NDC, 2 package rows20241225_b1df4c81-333b-450d-963e-6670ab9bbda9.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78611-414678611-4146-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN MONOLAURATE6W9PS8B71JIACT
ISOSTEARYL ISOSTEARATEIV0Z586Z4YIACT
DECYL ISOSTEARATENRB038QC02IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
MAGNOLIA BIONDII FLOWER BUDDZH9BOM6KDIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
PRUNUS PERSICA FLOWER19GWB0JENHIACT
EUPHRASIA STRICTAC9642I91WLIACT
XANTHAN GUMTTV12P4NEEIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ALUMINUM OXIDELMI26O6933IACT
ISOSTEARIC ACIDX33R8U0062IACT
SOYBEAN LECITHIN1DI56QDM62IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
SODIUM BENZOATEOJ245FE5EUIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESmall World Brandsb1df4c81-333b-450d-963e-6670ab9bbda92024-12-20WarningsExact identifier
ndc (package): 78611-4146-1
ndc (product): 78611-4146
ndc11 (package): 78611414601
spl id: 4d0b9d10-5958-4781-9b7b-08a7e4b8d844
spl set id: b1df4c81-333b-450d-963e-6670ab9bbda9

Reported adverse events (FAERS/openFDA)#

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