Welmedix ®

Welmedix ®
SPL v1
SPL
SPL Set ID 48da4589-0f5a-c25b-e063-6394a90ac18b
Route
TOPICAL
Published
Effective Date 2026-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (60 mg) Zinc Oxide (50 mg)
Inactive Ingredients
Aloe Barbadensis Leaf Magnesium Disodium Edta Silica Dimethyl Silylate Water Ethylhexyl Palmitate C12-15 Alkyl Benzoate Styrene/acrylamide Copolymer (mw 500000) Glycerin Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Dimethicone 100 Alumina Sodium Chloride Benzyl Alcohol Sorbitan Olivate Hydrogen Dimethicone (13 Cst) Niacinamide Cucumis Sativus (cucumber) Fruit Ethylhexylglycerin Aluminum Starch Octenylsuccinate Punica Granatum Fruit Juice Calendula Officinalis Flower Vitis Vinifera (grape) Seed Oil Camellia Sinensis Leaf Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-20

Description

Titanium Dioxide 6% Zinc Oxide 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 6% Zinc Oxide 5%

Uses
  • Helps prevent sunburn
Warnings

For external use only

Directions:
  • 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
Active Ingredients

Titanium Dioxide 6%

Zinc Oxide 5%

Other Information:

Protect the product from excessive heat and direct sun.

Inactive Ingredients

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

When Using This Product

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

Stop Use and Ask Doctor If
  • rash occurs
Principal Display Panel Tube

Welmedix ® HomeCare PRO

Fragile Skin Dual Mineral Sunscreen

Protects + Hydrates

Net Wt 1.7 fl oz (50mL)

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • Helps prevent sunburn
Purpose

Sunscreen

Warnings

For external use only

Directions:
  • 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
Active Ingredients (Active ingredients)

Titanium Dioxide 6%

Zinc Oxide 5%

Other Information:

Protect the product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)

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

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • rash occurs
Principal Display Panel Tube

Welmedix ® HomeCare PRO

Fragile Skin Dual Mineral Sunscreen

Protects + Hydrates

Net Wt 1.7 fl oz (50mL)

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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