Mineral Moisture Defense

Manufacturer
MDSolarSciences
Effective date
2018-11-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:57:12

Label at a glance#

ProductMineral Moisture Defense Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn If used 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: Ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection ...

Storage and handling

Shake well. Rub in well. Protect the product in this container from excessive heat and direct sunlight May stain some fabrics You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Titanium Dioxide 2%Sunscreen
Zinc Oxide 17%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used 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 - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

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

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.

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: Ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10a.m. – 2p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

STORAGE AND HANDLING SECTION

Shake well. Rub in well.

  • Protect the product in this container from excessive heat and direct sunlight
  • May stain some fabrics
  • You may report serious adverse reactions to:
    Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222

Inactives

INACTIVE INGREDIENT SECTION

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polyester-8, Polysilicone-15, Behenic Acid, Camelia Sinensis Leaf Extract, Caprooyl Phytosphingosine, Ceramide AP, Ceramide EOP, Ceramide EOS, Ceramide NP, Ceramide NS, Ceteareth-25, Cetyl Alcohol, Cholesterol, Glycerin, Iron Oxides, PEG/PPG-18/18 Dimethicone, Punica Granatum Extract, Silica, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethoxycaprylysilane, Vaccinum Macrocarpon (Cranberry) Fruit Extract

SPL UNCLASSIFIED SECTION

Distributed by:
MDSolarSciences Corp.
40 Richards Avenue, 3rd Fl., Norwalk, CT 06854

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MDSolarSciences™

50
MINERAL
MOISTURE
DEFENSE

body

BROAD SPECTRUM
SPF 50
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™

developed & approved
by Dermatologists

Water resistant (80 minutes)
Non-comedogenic – won't clog pores
Family Formula

sun care

Net Wt. 113 g - 4 Oz.

Principal Display Panel - 113 g Tube Carton
Principal Display Panel - 113 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49358-558-012023-01-30C16284748780-1f386c649-e6e6-0266-e053-dadaa90a7c1aMineral Moisture Defense Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-558-01Mineral Moisture Defense Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen1 in 1 CARTONCREAM13
49358-558-01Mineral Moisture Defense Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen113 g in 1 TUBECREAM1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-558MINERAL MOISTURE DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]3Legacy NDC, 2 package rows20181109_960ad8e2-34cb-45e1-ac9d-a5a4b16e9287.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49358-55849358-558-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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
3f747d4f-0a49-4dc4-b8f8-9d92504cafd4960ad8e2-34cb-45e1-ac9d-a5a4b16e92872018-11-08WarningsExact identifier
spl id: 3f747d4f-0a49-4dc4-b8f8-9d92504cafd4
spl set id: 960ad8e2-34cb-45e1-ac9d-a5a4b16e9287

Reported adverse events (FAERS/openFDA)#

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