FDA.reportPublic FDA data

THE MELT MIST

Manufacturer
Dune Suncare, Inc.
Effective date
2025-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:27:12

Label at a glance#

ProductTHE MELT MIST Sheerest Mineral Mist Suncare for Body
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 spread evenly by hand 15 minutes before sun exposure reapply after swimming, excessive perspiring, or anytime after towel drying use on children under 6 months of age: consult 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 p...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.4%

Zinc Oxide 15.7%

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 spread evenly by hand 15 minutes before sun exposure
  • reapply after swimming, excessive perspiring, or anytime after towel drying
    • use on children under 6 months of age: consult 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

Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Bisabolol, Butyloctyl Salicylate, C-18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Isononyl Isononanoate, Isocetyl Stearoyl Stearate, Methyl Dihydroabietate, Microcrystalline Cellulose, Musa Sapientum (Banana) Fruit Extract, Polyester-8, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUNE SUNCARE

THE
MELT MIST

SHEEREST MINERAL

MIST SUNCARE

FOR BODY

BROAD SPECTRUM

SPF 50

WATER & SWEAT

RESISTANCE

(80 MINUTES)

Long-Lasting

Hydration

Enriched with

Aloe & Vitamin E

Antioxidant Rich

Fragrance Free

177 mL

6 FL OZ

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82757-205-00THE MELT MISTSheerest Mineral Mist Suncare for Body177 mL in 1 BOTTLE, SPRAYSPRAY1771

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82757-20582757-205-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SODIUM GLUCONATER6Q3791S76IACT
ALUMINALMI26O6933IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MUSA ACUMINATA FRUITT6ENY6RV6WIACT
CITRIC ACID2968PHW8QPIACT
CELLULOSE GUMK679OBS311IACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
BENTONITEA3N5ZCN45CIACT
BISABOLOL24WE03BX2TIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
ISOCETYL STEAROYL STEARATEIJV4LS383RIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
WATER059QF0KO0RIACT
C18-21 ALKANE33822S0M40IACT
GLYCERINPDC6A3C0OXIACT
SILICA, TRIMETHYLSILYL CAPPEDVU10KU4B9SIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
CETEARYL ALCOHOL2DMT128M1SIACT
COCO-GLUCOSIDEICS790225BIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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 MELT MIST Sheerest Mineral Mist Suncare for BodyTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.465d3277-7798-512a-e063-6294a90a20652025-12-20WarningsExact identifier
ndc (package): 82757-205-00
ndc (product): 82757-205
ndc11 (package): 82757020500
spl id: 465d2cf2-e3fd-4801-e063-6294a90a1a3d
spl set id: 465d3277-7798-512a-e063-6294a90a2065

Reported adverse events (FAERS/openFDA)#

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