WELMEDIX HOMECARE PRO FRAGILE SKIN DUAL MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion

Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen by

Drug Labeling and Warnings

Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Welmedix LLC, DERMA CARE RESEARCH LABS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 6%
Zinc Oxide 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

For external use only

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

Keep out of reach of children.

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

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

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

Principal Display Panel Tube

Welmedix ®HomeCare PRO

Fragile Skin Dual Mineral Sunscreen

Protects + Hydrates

Net Wt 1.7 fl oz (50mL)

INGREDIENTS AND APPEARANCE

WELMEDIX HOMECARE PRO FRAGILE SKIN DUAL MINERAL SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24330-415
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
DIMETHICONE 100 (UNII: RO266O364U)
ALUMINA (UNII: LMI26O6933)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBITAN OLIVATE (UNII: MDL271E3GR)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
NIACINAMIDE (UNII: 25X51I8RD4)
CUCUMIS SATIVUS (CUCUMBER) FRUIT (UNII: YY7C30VXJT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PUNICA GRANATUM FRUIT JUICE (UNII: 99S671U9KB)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
VITIS VINIFERA (GRAPE) SEED OIL (UNII: 930MLC8XGG)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24330-415-02	1 in 1 BOX	01/20/2026
1	NDC: 24330-415-01	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 24330-415-03	2 in 1 BOX	01/20/2026
2	NDC: 24330-415-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/20/2026

Labeler - Welmedix LLC (118665984)

Establishment
Name	Address	ID/FEI	Business Operations
DERMA CARE RESEARCH LABS, LLC		116817470	manufacture(24330-415)