FDA.reportPublic FDA data

THE MINERAL MELT

Manufacturer
Dune Suncare, Inc.
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:27:12

Label at a glance#

ProductTHE MINERAL MELT Invisible Mineral Suncare for Face
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

helps prevent sunburn 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

Dosage and administration

apply liberally and evenly 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating at least every 2 hours children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 2.3%

Zinc Oxide 4.8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply:
    • after 40 minutes of swimming or sweating
    • at least every 2 hours
    • children under 6 months: Ask a doctor
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.–2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Maltodextrin, Polyester-8, Benzyl Alcohol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Lecithin, Glyceryl Caprylate, C15-19 Alkane, Silica, Polyhydroxystearic Acid, Alumina, Stearic Acid, Xanthan Gum, Triethoxycaprylylsilane, Polyglyceryl-6 Laurate, Caprylhydroxamic Acid, Sodium Hydroxide, Carnosine, Polyglycerin-6, Canola Oil, Sorbitan Oleate, Caesalpinia Spinosa Fruit Pod Extract, Sorbitan Isostearate, Cistus Monspeliensis Extract, Helianthus Annuus (Sunflower) Sprout Extract, Daucus Carota Sativa (Carrot) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Beta-Carotene, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Sodium Benzoate.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUNE SUNCARE

THE
MINERAL
MELT

INVISIBLE MINERAL

SUNCARE FOR

FACE

BROAD SPECTRUM

SPF 30

Hydrating, Brightening

& FIrming

Youth-Promoting

Peptides

Blue Light Defense

Fragrance Free

50 mL

1.7 FL OZ

PDPPDP

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
82757-203-00THE MINERAL MELTInvisible Mineral Suncare for Face50 mL in 1 BOTTLELOTION501

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82757-20382757-203-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
HELIANTHUS ANNUUS SPROUT4P26HG1S5WIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM HYDROXIDE55X04QC32IIACT
SILICA, TRIMETHYLSILYL CAPPEDVU10KU4B9SIACT
STEARIC ACID4ELV7Z65APIACT
CISTUS MONSPELIENSIS WHOLET2OG06826LIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
BETA-CAROTENE01YAE03M7JIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
BENZYL ALCOHOLLKG8494WBHIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
CARNOSINE8HO6PVN24WIACT
CANOLA OIL331KBJ17RKIACT
ALUMINALMI26O6933IACT
XANTHAN GUMTTV12P4NEEIACT
POLYGLYCERIN-6M51422LRAMIACT
SORBITAN OLEATE06XEA2VD56IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
MALTODEXTRIN7CVR7L4A2DIACT
C15-19 ALKANECI87N1IM01IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAESALPINIA SPINOSA FRUIT PODEXY4496LWDIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
POLYGLYCERYL-6 LAURATEQ48X4BL3TVIACT
DAUCUS CAROTA SATIVA (CARROT) SEED OIL595AO13F11IACT
GLYCERINPDC6A3C0OXIACT
DAUCUS CAROTA SATIVA (CARROT) JUICEQXF936IX43IACT

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
THE MINERAL MELT Invisible Mineral Suncare for FaceTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.46557319-7546-e712-e063-6394a90a3cfe2025-12-19WarningsExact identifier
ndc (package): 82757-203-00
ndc (product): 82757-203
ndc11 (package): 82757020300
spl id: 465572ea-d696-7d5d-e063-6294a90a8f8e
spl set id: 46557319-7546-e712-e063-6394a90a3cfe

Reported adverse events (FAERS/openFDA)#

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