FDA.reportPublic FDA data

Melan RX

Product NDC
82635-403
11-digit product format
826350403
Labeler code
82635
Product ID
82635-403_42f3c4f9-335e-595e-e063-6294a90a20f0
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Melan RX
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-23
Substance
ZINC OXIDE
Active strength
132 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Melan RX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE132 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
f4bdf20c-b6bc-55f1-e053-2995a90ac308Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82635-403-01Melan RX45 mL in 1 BOTTLELOTION455

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82635-403MELAN RX (ZINC OXIDE) LOTION [MELAN RX]3Current NDC, 1 package rows20241027_f4bdf20c-b6bc-55f1-e053-2995a90ac308.zip

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 123 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Untinted Sheer DefenseTITANIUM DIOXIDE, ZINC OXIDEKristina Lerner35be50b7-a9af-29ee-e063-6394a90a45ba2025-12-15Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724ea3c-b018-c125-e063-6394a90a01f12025-12-15Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC37252429-d692-c05a-e063-6294a90a6af62025-12-15Exact identifier
application number: M020
Parasol Daily Mineral SunscreenZINC OXIDEBodi & Wax, LLC35d2fbeb-935b-f0a9-e063-6294a90acd792025-12-15Exact identifier
application number: M020
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation423c7e62-ad50-0dc3-e063-6294a90ad05a2025-12-15WarningsExact identifier
application number: M020
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC3699c107-d063-cc6f-e063-6394a90a6ad42025-12-15Exact identifier
application number: M020
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation44776529-3aa6-4fa3-b2ce-f624c4cf41bd2025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEJMSE Management, LLC36ec860f-2066-196c-e063-6294a90a21212025-12-15Exact identifier
application number: M020
Parasol Daily Mineral SunscreenZINC OXIDEBodi & Wax, LLC35d3262a-1d8d-2afa-e063-6294a90afd492025-12-15Exact identifier
application number: M020
Parasol Daily Mineral Sunscreen Non-TintedZINC OXIDEBodi & Wax, LLC35d37c2e-abc0-6bda-e063-6294a90a8fc32025-12-15Exact identifier
application number: M020
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC36999510-88f0-64fc-e063-6294a90a3d092025-12-15Exact identifier
application number: M020
Parasol Daily Mineral Sunscreen Non-TintedZINC OXIDEBodi & Wax, LLC35d3486c-c6e8-4d31-e063-6294a90a12192025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen CreamZINC OXIDEESTILO SALON & SPA LLC3699f6df-63b8-f255-e063-6394a90af2c42025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen CreamZINC OXIDEESTILO SALON & SPA LLC369a5997-7dbe-254d-e063-6394a90a5bef2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEESTILO SALON & SPA LLC369a8a99-c755-3c7f-e063-6394a90ac16c2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEESTILO SALON & SPA LLC369abc9d-9c20-5397-e063-6394a90a17232025-12-15Exact identifier
application number: M020
Sunshade Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37dec631-fdaf-fbdf-e063-6394a90a6c2b2025-12-15Exact identifier
application number: M020
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37527317-0f10-d7e6-e063-6394a90a35a62025-12-15Exact identifier
application number: M020
Sunshade Mineral Stick SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee31be-bfda-f052-e063-6294a90ac0bb2025-12-15Exact identifier
application number: M020
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC3751544d-e093-3d19-e063-6394a90aefc32025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82635-403-018263504030145 mL in 1 BOTTLE (82635-403-01) 45 ml2022-03-23NoNoCurrent