FDA.reportPublic FDA data

Mineral KidCreme 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 01:02:24

Label at a glance#

ProductMineral KidCreme 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 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 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 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/ Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Ubiquinone (CoQ10), Camellia Sinensis Leaf Extract (Green Tea), Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Squalane, Polyhydroxystearic Acid, Silica, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Iron Oxides (CI 77491, CI 77492, 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 ®

PROTECT & NOURISH

MINERAL
KIDCRÈME ®

Broad Spectrum Sunscreen SPF 50
Water Resistant (80 Min)

SPF
50

Natural, sheer protection
for humans 6 months + older

DERMATOLOGIST DEVELOPED

3.4 FL OZ / 100 ML

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49358-584-012025-06-05C16284748780-12cef2736-7aa5-d83d-e063-dadaa90ab31fMineral KidCrème ® SPF 50 Mineral Broad Spectrum Sunscreen SPF 50 Water Resistant (80 min)
49358-584-012025-01-30C16284748780-12cef2736-7aa5-d83d-e063-dadaa90ab31fMineral KidCrème ® SPF 50 Mineral Broad Spectrum Sunscreen SPF 50 Water Resistant (80 min)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-584-01Mineral KidCreme SPF 50100 mL in 1 TUBECREAM1002
49358-584-01Mineral KidCreme SPF 501 in 1 CARTONCREAM12

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49358-58449358-584-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERRSA9I561OKIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
POLYSILICONE-15F8DRP5BB29IACT
POMEGRANATE JUICE99S671U9KBIACT
CRANBERRY0MVO31Q3QSIACT
UBIDECARENONEEJ27X76M46IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SQUALANEGW89575KF9IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
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 KidCreme SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences9ec56c68-6fea-444b-aeed-0b5d60c42e752025-06-05WarningsExact identifier
ndc (package): 49358-584-01
ndc (product): 49358-584
ndc11 (package): 49358058401
spl id: 36dab0f1-afa7-a7f3-e063-6294a90aaee7
spl set id: 9ec56c68-6fea-444b-aeed-0b5d60c42e75

Reported adverse events (FAERS/openFDA)#

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