FDA.reportPublic FDA data

Dermatone Mineral SPF 30 Sunscreen Lotion

Manufacturer
Dermatone Labs LLC | Inspec Solutions LLC | Inspec Solutions LLC.
Effective date
2026-02-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:46:26

Label at a glance#

ProductDermatone Mineral SPF 30
Active ingredientZINC OXIDE
Label structure6 sections

Label contents#

Full prescribing information#

Active ingredients                 Purpose

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%                        Sunscreen

INDICATIONS & USAGE SECTION

Uses

• Helps prevent sunburn, higher SPF gives more sunburn protection

• if used as directed with other sun protection measures ( see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

WARNINGS

For external use only.

When using this product:

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

Inactive Ingredeints

INACTIVE INGREDIENT SECTION

WATER
CAPRYLIC/CAPRIC TRIGLYCERIDE
COCO-CAPRYLATE
BUTYLOCTYL SALICYLATE
NIACINAMIDE
POLYHYDROXYSTEARIC ACID
GLYCERIN
PANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
SUCROSE PALMITATE
XANTHAN GUM
CITRIC ACID
SACCHARIDE ISOMERATE
SUCROSE TRISTEARATE
SODIUM STEAROYL GLUTAMATE
BENZYL ALCOHOL
DEHYDROACETIC ACID
SODIUM PHYTATE

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.

• Reapply at least every 2 hours

٠apply to all areas of the skin exposed to the sun.
٠Reapply as needed or after towel drying, swimming, or sweating.

• Sun Protection Measures. Spending tme in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from
10 a.m. - 2. p.m. • wear a long-sleeve shirt, pants, hats, and sunglasses.
• children under 6 months: Ask a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54414-03054414-030-02, 54414-030-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
COCO-CAPRYLATE4828G836N6IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
NIACINAMIDE25X51I8RD4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SUCROSE PALMITATE3OSQ643ZK5IACT
GLYCERYL STEARATE230OU9XXE4IACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID2968PHW8QPIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
WATER059QF0KO0RIACT
SUCROSE TRISTEARATE71I93STU5MIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
BENZYL ALCOHOLLKG8494WBHIACT
DEHYDROACETIC ACID2KAG279R6RIACT
SODIUM PHYTATE88496G1ERLIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermatone Mineral SPF 30ZINC OXIDE 20%Dermatone Labs LLC26e3209f-cb5c-484e-9b2e-74dc397d47902026-02-18WarningsExact identifier
ndc (package): 54414-030-03
ndc (package): 54414-030-02
ndc (product): 54414-030
ndc11 (package): 54414003003
ndc11 (package): 54414003002
spl id: 4b210203-6e23-22c6-e063-6394a90a88c9
spl set id: 26e3209f-cb5c-484e-9b2e-74dc397d4790

Reported adverse events (FAERS/openFDA)#

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