FDA.reportPublic FDA data

Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen

Manufacturer
Welmedix LLC | DERMA CARE RESEARCH LABS, LLC
Effective date
2026-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:11

Label at a glance#

ProductWelmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Shake well before use Apply liberally 15 minutes before sun exposure and as needed Re-apply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6%
Zinc Oxide 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes. Rinse with water to remove.

Stop use and ask doctor if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • Apply liberally 15 minutes before sun exposure and as needed
  • Re-apply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours

Other Information:

OTC - QUESTIONS SECTION

Protect the product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Ethylhexyl Palmitate, C12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Alumina, Sodium Chloride, Benzyl Alcohol, Sorbitan Olivate, Hydrogen Dimethicone, Aluminum Starch Octenylsuccinate, Ethylhexylglycerin, Silica, Disodium EDTA, Aloe Barbadensis Leaf Extract, Propanediol, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Camellia Sinensis Leaf Extract, Punica Granatum Fruit Juice, Calendula Officinalis Extract

Principal Display Panel Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Welmedix ® HomeCare PRO

Fragile Skin Dual Mineral Sunscreen

Protects + Hydrates

Net Wt 1.7 fl oz (50mL) Welmedix HomeCare Pro LabelWelmedix HomeCare Pro Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24330-415-01Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen50 mL in 1 TUBELOTION501
24330-415-02Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen1 in 1 BOXLOTION11
24330-415-03Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen2 in 1 BOXLOTION21

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24330-41524330-415-01, 24330-415-02, 24330-415-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
MAGNESIUM DISODIUM EDTANDT563S5VZIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
WATER059QF0KO0RIACT
ETHYLHEXYL PALMITATE2865993309IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
GLYCERINPDC6A3C0OXIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
DIMETHICONE 100RO266O364UIACT
ALUMINALMI26O6933IACT
SODIUM CHLORIDE451W47IQ8XIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
BENZYL ALCOHOLLKG8494WBHIACT
SORBITAN OLIVATEMDL271E3GRIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
NIACINAMIDE25X51I8RD4IACT
CUCUMIS SATIVUS (CUCUMBER) FRUITYY7C30VXJTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
PUNICA GRANATUM FRUIT JUICE99S671U9KBIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
VITIS VINIFERA (GRAPE) SEED OIL930MLC8XGGIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
PROPANEDIOL5965N8W85TIACT

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
Welmedix HomeCare PRO Fragile Skin Dual Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEWelmedix LLC48da4589-0f5a-c25b-e063-6394a90ac18b2026-01-20WarningsExact identifier
ndc (package): 24330-415-03
ndc (package): 24330-415-01
ndc (package): 24330-415-02
ndc (product): 24330-415
ndc11 (package): 24330041501
ndc11 (package): 24330041503
ndc11 (package): 24330041502
spl id: 48d8b78e-d503-d380-e063-6394a90aca15
spl set id: 48da4589-0f5a-c25b-e063-6394a90ac18b

Reported adverse events (FAERS/openFDA)#

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