FDA.reportPublic FDA data

Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen

Product NDC
24330-415
11-digit product format
243300415
Labeler code
24330
Product ID
24330-415_48d8b78e-d503-d380-e063-6394a90aca15
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Welmedix LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-20
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 50 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE60 mg/mL
ZINC OXIDE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48da4589-0f5a-c25b-e063-6394a90ac18bAvailable on FDA.report

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

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 220 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD2499e14a-c14f-ea13-e063-6394a90a62f52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a7bee2-3802-4786-e063-6294a90a6ab52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24aa19c8-86d9-c691-e063-6394a90a691e2025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a98d3d-f830-9614-e063-6394a90aa7d12025-03-22WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM CHAMPAGNE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfb871b-460f-271a-e053-6394a90acad22025-03-22WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8gZINC OXIDENAKED SUNDAYS PTY LTD2f42d22a-983e-d304-e063-6294a90a37192025-03-22WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM ROSE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfbd0dd-8961-5fd0-e053-6294a90a5de42025-03-22WarningsExact identifier
application number: M020
Naked Sundays Face Body Clear Glow Sunstick SPF50 SHIMMER Broad Spectrum SPF50 19gAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5% ,OCTOCRYLENE 8%NAKED SUNDAYS PTY LTD2f47a6c9-dd0a-da94-e063-6294a90a9a452025-03-22WarningsExact identifier
application number: M020
Obagi Skintrinsiq Firming ProtocolTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLC67ba9f32-bbf4-4c14-9e97-08f1cb7d39962025-03-21WarningsExact identifier
application number: M020
Obagi Skintrinsiq Brightening ProtocolHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC2f75ebf7-d6b6-45c6-ad5b-61739d260ff72025-03-21WarningsExact identifier
application number: M020
Hello Kitty Fun Broad Spectrum SPF 40ZINC OXIDEThe Creme Shop Inc30d37581-122c-ec92-e063-6294a90ab4252025-03-21WarningsExact identifier
application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40ZINC OXIDEThe Creme Shop Inc30d3ed8c-f424-8d95-e063-6394a90a0cbc2025-03-21WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.c7142781-fa57-43e5-9436-cb29dd03a6692025-03-21WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION00ec7d9c-8550-45ce-8d0a-ef2caf84f98d2025-03-21WarningsExact identifier
application number: M020
Obagi Skintrinsiq Clarifiying ProtocolSALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDEObagi Cosmeceuticals LLC08ba9ea8-73fd-472b-9cc4-67df167352ec2025-03-21WarningsExact identifier
application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC3e51da46-6a81-4b74-b16e-3fc298a4ba592025-03-20WarningsExact identifier
application number: M020
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC2d2c58e2-0d15-4383-adae-12fc17b8ea502025-03-20WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC1907126c-fd95-86e8-e063-6394a90a23ca2025-03-20WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 PlusZINC OXIDEKenvue Brands LLC4504a10d-6130-4ec5-823a-ab970709e6d72025-03-20WarningsExact identifier
application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEEai-jr 286, Inc30caf1dd-142d-85d3-e063-6394a90a0c882025-03-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24330-415-012433004150150 mL in 1 TUBE50 mlHistorical
24330-415-02243300415021 TUBE in 1 BOX (24330-415-02) / 50 mL in 1 TUBE (24330-415-01) 1 tube2026-01-20NoNoCurrent
24330-415-03243300415032 TUBE in 1 BOX (24330-415-03) / 50 mL in 1 TUBE (24330-415-01) 2 tube2026-01-20NoNoCurrent