THE MELT MIST SHEEREST MINERAL MIST SUNCARE FOR BODY- titanium dioxide, zinc oxide spray

THE MELT MIST by

Drug Labeling and Warnings

THE MELT MIST by is a Otc medication manufactured, distributed, or labeled by Dune Suncare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 3.4%

Zinc Oxide 15.7%

Purpose

Sunscreen

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

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

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

Directions

• 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

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

Inactive ingredients

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

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

INGREDIENTS AND APPEARANCE

THE MELT MIST  SHEEREST MINERAL MIST SUNCARE FOR BODY
titanium dioxide, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82757-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	34 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	157 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ALUMINA (UNII: LMI26O6933)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MUSA ACUMINATA FRUIT (UNII: T6ENY6RV6W)
CITRIC ACID (UNII: 2968PHW8QP)
CELLULOSE GUM (UNII: K679OBS311)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
BENTONITE (UNII: A3N5ZCN45C)
BISABOLOL (UNII: 24WE03BX2T)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
WATER (UNII: 059QF0KO0R)
C18-21 ALKANE (UNII: 33822S0M40)
GLYCERIN (UNII: PDC6A3C0OX)
SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO-GLUCOSIDE (UNII: ICS790225B)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82757-205-00	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2025

Labeler - Dune Suncare, Inc. (049095642)