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

Purpose

Sunscreen

Description

Titanium Dioxide 3.4% Zinc Oxide 15.7%


Medication Information

Warnings

For external use only

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

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.

Description

Titanium Dioxide 3.4% Zinc Oxide 15.7%

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

Do Not Use

on damaged or broken skin

Active Ingredients

Titanium Dioxide 3.4%

Zinc Oxide 15.7%

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

Warnings

For external use only

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

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

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

Titanium Dioxide 3.4%

Zinc Oxide 15.7%

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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