Tinted Moisturizer Spf 30 Dune

Tinted Moisturizer Spf 30 Dune
SPL v3
SPL
SPL Set ID c12272c3-d4ed-2212-e053-2995a90add37
Route
TOPICAL
Published
Effective Date 2021-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (13 mg) Titanium Dioxide (2.4 mg)
Inactive Ingredients
Magnesium Potassium Aluminosilicate Fluoride Trisodium Ethylenediamine Disuccinate Ferrosoferric Oxide Mica Polyglyceryl-10 Pentastearate Cetyl Dimethicone 150 Sodium Chloride Polyglyceryl-3 Ricinoleate Tocopherol Polyglyceryl-2 Isostearate Silicon Dioxide Lauroyl Lysine Isostearic Acid 1,2-hexanediol Water Cetyl Ethylhexanoate Polyhydroxystearic Acid (2300 Mw) Rosemary Neopentyl Glycol Diethylhexanoate Polyglyceryl-6 Polyricinoleate Glycerin Acacia Decurrens Flower Wax Disteardimonium Hectorite Hydrogenated Jojoba Oil/jojoba Oil, Randomized (iodine Value 40-44) Helianthus Annuus Flowering Top Ferric Oxide Red Ferric Oxide Yellow Coco-caprylate/caprate Polymethylsilsesquioxane (4.5 Microns) Propanediol 3'-hydroxyacetophenone Caprylyl Glycol Rice Bran Tetrahexyldecyl Ascorbate Allantoin Cetyl Alcohol Helianthus Annuus Seed Wax Polyglycerin-3 Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-01
Description

Active ingredient Titanium Dioxide 2.4% Zinc Oxide 13%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

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

Directions

  • Shake well. Apply liberally and evenly 15 minutes before sun exposure
  • Children under six months of age: ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF vaue 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 sleeved shirts, pants, hats, and sunglasses
  • Reapply: at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
Description

Active ingredient Titanium Dioxide 2.4% Zinc Oxide 13%

Section 42229-5

Other information Protect the product in this container from excessive heat and direct 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 or irritation develops and lasts

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

Section 51727-6

Inactive ingredients Water (Aqua/Eau), Cetyl Ethylhexanoate, Neopentyl Glycol Diethylhexanoate, Coco-Caprylate/Caprate, Polymethylsilsesquioxane, Polyglyceryl-6 Polyricinoleate, Propanediol, Cetyl Dimethicone, Synthetic Fluorphlogopite, Glycerin, Jojoba Esters, Polyglyceryl-2 Isostearate, Polyhydroxystearic Acid, Acacia Decurrens Flower Wax, Sodium Chloride, Polyglyceryl-3, Polyricinoleate, Disteardimonium Hectorite, Polyglyceryl-10 Pentaisostearate, Hydroxyacetophenone, Silica, Lauroyl, Lysine, Isostearic Acid, Caprylyl Glycol, 1,2-Hexanediol, Oryza Sativa (Rice) Bran Extract, Tetrahexyldecyl Ascorbate, Allantoin, Cetyl Alcohol, Helianthus Annuus (Sunflower) Seed Wax, Polyglycerin-3, Dimethicone, Trisodium Ethylenediamine, Disuccinate, Helianthus Annuus (Sunflower) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Mica (CI 77019), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Sunscreen

Section 55106-9

Active ingredient

Titanium Dioxide 2.4%

Zinc Oxide 13%

Structured Label Content

Indications and Usage (34067-9)

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 (34068-7)

Directions

  • Shake well. Apply liberally and evenly 15 minutes before sun exposure
  • Children under six months of age: ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF vaue 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 sleeved shirts, pants, hats, and sunglasses
  • Reapply: at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

Other information Protect the product in this container from excessive heat and direct 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 or irritation develops and lasts

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

Section 51727-6 (51727-6)

Inactive ingredients Water (Aqua/Eau), Cetyl Ethylhexanoate, Neopentyl Glycol Diethylhexanoate, Coco-Caprylate/Caprate, Polymethylsilsesquioxane, Polyglyceryl-6 Polyricinoleate, Propanediol, Cetyl Dimethicone, Synthetic Fluorphlogopite, Glycerin, Jojoba Esters, Polyglyceryl-2 Isostearate, Polyhydroxystearic Acid, Acacia Decurrens Flower Wax, Sodium Chloride, Polyglyceryl-3, Polyricinoleate, Disteardimonium Hectorite, Polyglyceryl-10 Pentaisostearate, Hydroxyacetophenone, Silica, Lauroyl, Lysine, Isostearic Acid, Caprylyl Glycol, 1,2-Hexanediol, Oryza Sativa (Rice) Bran Extract, Tetrahexyldecyl Ascorbate, Allantoin, Cetyl Alcohol, Helianthus Annuus (Sunflower) Seed Wax, Polyglycerin-3, Dimethicone, Trisodium Ethylenediamine, Disuccinate, Helianthus Annuus (Sunflower) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Mica (CI 77019), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Sunscreen

Section 55106-9 (55106-9)

Active ingredient

Titanium Dioxide 2.4%

Zinc Oxide 13%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:27.747839 · Updated: 2026-03-14T23:02:00.533418