Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2114fc3b-c8ce-45d2-8a82-4dc54f0adaf3
Route
TOPICAL
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (48 mg) Titanium Dioxide (23 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Glycerin Dimethicone Maltodextrin Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Benzyl Alcohol Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Hydrogenated Soybean Lecithin Glyceryl Monocaprylate C15-19 Alkane Silicon Dioxide Polyhydroxystearic Acid (2300 Mw) Aluminum Oxide Stearic Acid Xanthan Gum Triethoxycaprylylsilane Polyglyceryl-6 Laurate Caprylhydroxamic Acid Sodium Hydroxide Caesalpinia Spinosa Fruit Pod Carnosine Polyglycerin-6 Canola Oil Sorbitan Monooleate Sorbitan Isostearate Helianthus Annuus Sprout Cistus Monspeliensis Whole Carrot Carrot Seed Oil Beta Carotene Sunflower Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01
Description

Titanium dioxide, 2.3% Zinc oxide, 4.8%

Purpose

Sunscreen Sunscreen

Medication Information

Purpose

Sunscreen

Sunscreen

Description

Titanium dioxide, 2.3% Zinc oxide, 4.8%

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
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

Directions
  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating:
    • immediately after towel drying
    • at least every 2 hours.
  • Children under 6 months of age: 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m.-2p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Titanium dioxide, 2.3%

Zinc oxide, 4.8%

Inactive Ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Maltodextrin, Polyester-8, Benzyl Alcohol, Sodium Acrylate/Sodium Acryloylddimethyl 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

Principal Display Panel – 2 Ml Packet Label

DUNE

SUNCARE

THE

MINERAL

MELT

INVISIBLE MINERAL

SUNCARE FOR

FACE

BROAD SPECTRUM

SPF 30

Doctor-Developed

Hydrating,

Brightening &

Firming

Non-Comedogenic

Fragrance Free

2 mL

0.067 FL OZ

Principal Display Panel – 50 Ml Bottle Label

DUNE

THE

MINERAL

MELT

INVISIBLE MINERAL

SUNCARE FOR FACE

BROAD SPECTRUM

SPF 30

Sheerest Mineral

Hydration

Enriched with Youth

Peptides

Non-Comedogenic

Fragrance Free

50 mL

1.7 FL OZ

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
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating:
    • immediately after towel drying
    • at least every 2 hours.
  • Children under 6 months of age: 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m.-2p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Active Ingredients (Active ingredients)

Titanium dioxide, 2.3%

Zinc oxide, 4.8%

Inactive Ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Maltodextrin, Polyester-8, Benzyl Alcohol, Sodium Acrylate/Sodium Acryloylddimethyl 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

Principal Display Panel – 2 Ml Packet Label (Principal Display Panel – 2 mL Packet Label)

DUNE

SUNCARE

THE

MINERAL

MELT

INVISIBLE MINERAL

SUNCARE FOR

FACE

BROAD SPECTRUM

SPF 30

Doctor-Developed

Hydrating,

Brightening &

Firming

Non-Comedogenic

Fragrance Free

2 mL

0.067 FL OZ

Principal Display Panel – 50 Ml Bottle Label (Principal Display Panel – 50 mL Bottle Label)

DUNE

THE

MINERAL

MELT

INVISIBLE MINERAL

SUNCARE FOR FACE

BROAD SPECTRUM

SPF 30

Sheerest Mineral

Hydration

Enriched with Youth

Peptides

Non-Comedogenic

Fragrance Free

50 mL

1.7 FL OZ

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:55.840372 · Updated: 2026-03-14T23:02:45.179164