FDA.reportPublic FDA data

Mineral SPF 30 Brush-On Sun Defense

Manufacturer
Mineral Fusion brands
Effective date
2019-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:53:44

Label at a glance#

ProductMineral SPF 30 Brush-On Sun Defense
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection.

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor.

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 17.3%Sunscreen
Zinc Oxide 20.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.

Warnings

WARNINGS SECTION

  • When using this product keep out of eyes.
  • Rinse with water to remove.
  • Stop use and ask doctor if rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mica, Silica, Nylon-12, Caprylic/Capric Triglyceride, Tocopherol, Capryloyl Glycine, Undecylenoyl Glycine, Alaria Esculenta (Sea Kelp) Extract, Retinyl Palmitate, Iron Oxides.

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-428-1668 Mon-Fri 8 AM-5 PM PST

SPL UNCLASSIFIED SECTION

Dist. by Mineral Fusion
Petaluma, CA 94954 USA

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral SPF 30
Brush-On Sun Defense

Translucent Matte Finish
For All Skin Tones
Broad Spectrum Protection

MINERAL
FUSION®

BRUSH-ON
SPF 30
PROTECTION

Making Beauty Healthy®

Net Wt 0.14 oz e 4.0 g

Principal Display Panel - 4 g Tube Carton
Principal Display Panel - 4 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55789-1221-12025-01-30C16284748780-1f386c649-b32f-0266-e053-dadaa90a7c1aMineral SPF 30 Brush-On Sun Defense
55789-1221-12023-02-06C16284748780-1f386c649-b32f-0266-e053-dadaa90a7c1aMineral SPF 30 Brush-On Sun Defense
55789-1221-12023-01-30C16284748780-1f386c649-b32f-0266-e053-dadaa90a7c1aMineral SPF 30 Brush-On Sun Defense

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55789-1221-1Mineral SPF 30 Brush-On Sun Defense4 g in 1 TUBE, WITH APPLICATORPOWDER44
55789-1221-1Mineral SPF 30 Brush-On Sun Defense1 in 1 CARTONPOWDER14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55789-1221MINERAL SPF 30 BRUSH-ON SUN DEFENSE (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [MINERAL FUSION BRANDS]4Legacy NDC, 2 package rows20230208_0454007d-979f-4cc2-ae8d-7a2a11ca48dd.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55789-122155789-1221-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
MICAV8A1AW0880IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NYLON-12446U8J075BIACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
UNDECYLENOYL GLYCINE4D20464K2JIACT
ALARIA ESCULENTAEJ9JK8J58DIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
TOCOPHEROLR0ZB2556P8IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT

Source Document#

Source XML · Source PDF

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
710fda9f-82c2-41dd-8c9b-cba2b64a65d60454007d-979f-4cc2-ae8d-7a2a11ca48dd2019-12-31WarningsExact identifier
spl id: 710fda9f-82c2-41dd-8c9b-cba2b64a65d6
spl set id: 0454007d-979f-4cc2-ae8d-7a2a11ca48dd

Reported adverse events (FAERS/openFDA)#

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