FDA.reportPublic FDA data

Mineral Moisture Defense SPF 50

Manufacturer
MDSolarSciences
Effective date
2025-06-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:02:20

Label at a glance#

ProductMineral Moisture Defense SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 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

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...

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 611, Pompton Plains, NJ 07444

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 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 useon damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs

OTC - WHEN USING SECTION

When using this productkeep 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 611,
    Pompton Plains, NJ 07444

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polyester-8, Polysilicone-15, Ceramide AP, Ceramide EOP, Ceramide NP, Phytosphingosine, Tetrahexyldecyl Ascorbate (Vitamin C), Camelia Sinensis Leaf Extract (Green Tea), Punica Granatum Extract (Pomegranate), Vaccinum Macrocarpon (Cranberry) Fruit Extract, Water (Aqua), Polyhydroxystearic Acid, Silica, Sodium Lauroyl Lactylate, Ethylhexylglycerin, Cholesterol, Carbomer, Xanthan Gum, Triethoxycaprylysilane, May Contain: (CI 77891, CI 77492, CI 77491, CI 77499)

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

PRINCIPAL DISPLAY PANEL - 100 ML Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MDSOLARSCIENCES ®

MINERAL
MOISTURE
DEFENSE

Broad Spectrum SPF 50
Water Resistant (80 Min)
100% Mineral Sunscreen

SPF 50

Hydrating Mineral
Sunscreen Enriched
with Ceramides

DERMATOLOGIST
DEVELOPED

VITAMIN C
GREEN TEA

POMEGRANATE
CRANBERRY

3.4 FL OZ / 100 ML

PRINCIPAL DISPLAY PANEL - 100 ML Tube Carton
PRINCIPAL DISPLAY PANEL - 100 ML Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49358-583-012025-06-05C16284748780-12cef2736-961a-d83d-e063-dadaa90ab31fMineral Moisture Defense SPF 50 Broad Spectrum SPF 50 Sunscreen Water Resistant (80 min)
49358-583-012025-01-30C16284748780-12cef2736-961a-d83d-e063-dadaa90ab31fMineral Moisture Defense SPF 50 Broad Spectrum SPF 50 Sunscreen Water Resistant (80 min)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-583-01Mineral Moisture Defense SPF 501 in 1 CARTONCREAM12
49358-583-01Mineral Moisture Defense SPF 50100 mL in 1 TUBECREAM1002

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49358-58349358-583-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERRSA9I561OKIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
POLYSILICONE-15F8DRP5BB29IACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE 988KCS7120EIACT
CERAMIDE NP4370DF050BIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
POMEGRANATE JUICE99S671U9KBIACT
CRANBERRY0MVO31Q3QSIACT
WATER059QF0KO0RIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CHOLESTEROL97C5T2UQ7JIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
XANTHAN GUMTTV12P4NEEIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
Mineral Moisture Defense SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences05ad73f3-a4e8-4f78-8212-3e8e3bda988c2025-06-05WarningsExact identifier
ndc (package): 49358-583-01
ndc (product): 49358-583
ndc11 (package): 49358058301
spl id: 36d86ec1-c64d-d417-e063-6394a90a5f9f
spl set id: 05ad73f3-a4e8-4f78-8212-3e8e3bda988c

Reported adverse events (FAERS/openFDA)#

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