The Melt Mist

The Melt Mist
SPL v1
SPL
SPL Set ID 465d3277-7798-512a-e063-6294a90a2065
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (34 mg) Zinc Oxide (157 mg)
Inactive Ingredients
Propanediol Butyloctyl Salicylate Sodium Stearoyl Glutamate .alpha.-tocopherol Polyhydroxystearic Acid (2300 Mw) Sodium Gluconate Alumina Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Caprylyl Glycol Musa Acuminata Fruit Citric Acid Cellulose Gum Aloe Barbadensis Leaf Juice Caprylhydroxamic Acid Bentonite Bisabolol Isononyl Isononanoate Isocetyl Stearoyl Stearate Methyl Dihydroabietate Water C18-21 Alkane Glycerin Silica, Trimethylsilyl Capped Dicaprylyl Carbonate Cetearyl Alcohol Coco-glucoside Microcrystalline Cellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Titanium Dioxide 3.4% Zinc Oxide 15.7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.4% Zinc Oxide 15.7%

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

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
Do Not Use

on damaged or broken skin

Other Information
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Titanium Dioxide 3.4%

Zinc Oxide 15.7%

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

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.


Structured Label Content

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
Purpose

Sunscreen

Warnings

For external use only

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
Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Titanium Dioxide 3.4%

Zinc Oxide 15.7%

Inactive Ingredients (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

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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