FDA.reportPublic FDA data

Dermatone Mineral SPF 30

Product NDC
54414-030
11-digit product format
544140030
Labeler code
54414
Product ID
54414-030_4b210203-6e23-22c6-e063-6394a90a88c9
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide 20%
Dosage form
LOTION
Route
TOPICAL
Labeler
Dermatone Labs LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-21
Substance
ZINC OXIDE
Active strength
20 g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Dermatone Mineral SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100mL

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
26e3209f-cb5c-484e-9b2e-74dc397d4790Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54414-030-02Dermatone Mineral SPF 3089 mL in 1 CONTAINERLOTION893
54414-030-03Dermatone Mineral SPF 3059 mL in 1 CONTAINERLOTION593

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 124 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lip CrackTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37edc05c-82c3-90fe-e063-6294a90aa6012025-12-15Exact identifier
application number: M020
Restore And ReplenishZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ed8525-6ae4-4e86-e063-6294a90afeb82025-12-15Exact identifier
application number: M020
Sunshade Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee77dc-a96a-5efa-e063-6394a90affda2025-12-15Exact identifier
application number: M020
Sunshade Mineral SunscreenZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37df21f1-f36f-df43-e063-6294a90aea6f2025-12-15Exact identifier
application number: M020
Tinted Moisturizing Mineral SunscreenZINC OXIDEEDIT EUROSPA, LLC3751861d-3f3b-2ebd-e063-6294a90af8982025-12-15Exact identifier
application number: M020
Non Tinted Moisturizing Mineral SunscreenZINC OXIDEEDIT EUROSPA, LLC3751e278-b8b2-7bf4-e063-6394a90a42902025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37521c60-2fee-861e-e063-6294a90ad69a2025-12-15Exact identifier
application number: M020
MATTE Non Tinted Mineral SunscreenZINC OXIDEAllure Esthetics3725d947-b1fa-3b50-e063-6394a90adf102025-12-15Exact identifier
application number: M020
GLOW Tinted Mineral SunscreenZINC OXIDEAllure Esthetics37257bb2-d91d-6ff8-e063-6294a90a01b62025-12-15Exact identifier
application number: M020
Daily RestoreZINC OXIDETYRLIN ENTERPRISES, INC.35ce7133-badb-1bc4-e063-6294a90a74782025-12-15Exact identifier
application number: M020
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bee5f9-68d6-6302-e063-6394a90ada882025-12-15Exact identifier
application number: M020
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bfd54a-d7b7-f1a7-e063-6294a90a039b2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c03804-04e9-3d54-e063-6294a90a34072025-12-15Exact identifier
application number: M020
Deflectin Tinted Mineral SunscreenZINC OXIDEAEON AESTHETICS LLC35d14660-8900-2cb0-e063-6394a90a317d2025-12-15Exact identifier
application number: M020
Mineral Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf36c1-50c9-e848-e063-6294a90a66582025-12-15Exact identifier
application number: M020
Flash Invisible StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d2489e-4978-4fc3-e063-6294a90adfcc2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c010ad-e25d-f197-e063-6294a90a0efb2025-12-15Exact identifier
application number: M020
Flash Tinted StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d28590-e746-7996-e063-6294a90ac7d82025-12-15Exact identifier
application number: M020
Mineral Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf03f4-200a-5643-e063-6394a90a9e022025-12-15Exact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf708c-244e-63a8-e063-6394a90a3b962025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54414-030-025441400300289 mL in 1 CONTAINER (54414-030-02) 89 ml2025-08-21NoNoCurrent
54414-030-035441400300359 mL in 1 CONTAINER (54414-030-03) 59 ml2025-08-21NoNoCurrent