FDA.reportPublic FDA data

Sun Defense Minerals (Light)

Manufacturer
Eminence Organic Skin Care
Effective date
2025-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:20

Label at a glance#

ProductSun Defense Minerals (Light)
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions

Before use, shake or tap well
Apply liberally 15 minutes before sun exposure
Reapply

After 40 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.

WARNINGS SECTION

Warnings

For external use only
Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove
Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Silica, Mica, Butyloctyl Salicylate, Octyldodecanol, Tridecyl Salicylate, Iron Oxides, Mauritia Flexuosa (Buriti) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Phenylpropanol, Corn-Derived Propanediol, Aluminum Hydroxide, Caprylyl Glycol, Hydrogenated Plant-Derived Lecithin.

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Titanium Dioxide 21.8%; Zinc Oxide 23.5%......Sunscreen

OTC - PURPOSE SECTION

Purpose: Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredients Purpose

Titanium Dioxide 21.8%; Zinc Oxide 23.5%......Sunscreen

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

Warnings

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Before use, shake or tap well

Apply liberally 15 minutes before sun exposure

Reapply

After 40 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

Protect the product in this container from excessive heat and direct sun

Inactive ingredients

Silica, Mica, Butyloctyl Salicylate, Octyldodecanol, Tridecyl Salicylate, Iron Oxides, Mauritia Flexuosa (Buriti) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Phenylpropanol, Corn-Derived Propanediol, Aluminum Hydroxide, Caprylyl Glycol, Hydrogenated Plant-Derived Lecithin.

Retail boxRetail box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15751-3602-1Sun Defense Minerals (Light)5.5 g in 1 BOTTLE, DISPENSINGPOWDER5.51
15751-3602-1Sun Defense Minerals (Light)1 in 1 BOXPOWDER11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15751-3602SUN DEFENSE MINERALS (LIGHT) (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [EMINENCE ORGANIC SKIN CARE]1Current NDC, 2 package rows20250302_2e21f5bb-e7df-b43b-e063-6394a90a0f82.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15751-360215751-3602-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLPROPANOL0F897O3O4MIACT
PROPANEDIOL5965N8W85TIACT
MAURITIA FLEXUOSA FRUIT OIL48H19MS04LIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ZINC OXIDESOI2LOH54ZACTIB
IRON OXIDES1K09F3G675IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
OCTYLDODECANOL461N1O614YIACT
TOCOPHEROLR0ZB2556P8IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
HYDRATED SILICAY6O7T4G8P9IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
ndc (package): 15751-3602-1
ndc (product): 15751-3602
ndc11 (package): 15751360201
spl id: 2e21f60a-13bd-08ea-e063-6294a90a91d0
spl set id: 2e21f5bb-e7df-b43b-e063-6394a90a0f82
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e22cfde-10a1-3742-e063-6394a90ac0972025-02-14WarningsExact identifier
ndc (product): 15751-3602

Reported adverse events (FAERS/openFDA)#

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