(re) Setting 100% Mineral Powder Deep Broad Spectrum Spf 35

(re) Setting 100% Mineral Powder Deep Broad Spectrum Spf 35
SPL v5
SPL
SPL Set ID af4cb85b-1275-2105-e053-2995a90a7e74
Route
TOPICAL
Published
Effective Date 2020-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24.7 g)
Inactive Ingredients
Lauroyl Lysine Ferrosoferric Oxide Trimethylsiloxysilicate (m/q 0.6-0.8) Ascorbyl Palmitate Ceramide 3 Ferric Oxide Yellow Boron Nitride Triethoxycaprylylsilane Ferric Oxide Red Silicon Dioxide Calcium Aluminum Borosilicate Poly(methyl Methacrylate; 450000 Mw) Ethylhexylglycerin Sodium Dehydroacetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-14
Description

Active Ingredients Purpose Zinc Oxide 24.7% Sunscreen

Medication Information

Warnings and Precautions

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.

Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and Administration

Directions

  • Apply generously and evenly 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours

  • 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 value of 15 or higher and other sun

protection measures including: • limit your time in the sun, especially from 10

a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses •

  • Children under 6 months of age: ask a doctor.
Description

Active Ingredients Purpose Zinc Oxide 24.7% Sunscreen

Section 50565-1

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

Section 51727-6

Inactive Ingredients

Calcium Aluminum Borosilicate, Silica, Trimethylsiloxysilicate, Calcium Sodium Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Polyglyceryl-10 Pentaisostearate, Boron Nitride, Triethoxycaprylylsilane, Ethylhexylglycerin, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3, Iron Oxides (CI 77492, CI 77491, CI 77499)

Section 51945-4

(RE) Setting 100% Mineral Powder SPF 35 PA +++

0.12 oz/ 4.25 g

Section 55105-1

Uses

  • Helps prevent sunburn
  • If used as directed with oher sun protection measures( see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Section 55106-9

Active Ingredients Purpose

Zinc Oxide 24.7% Sunscreen

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

Directions

  • Apply generously and evenly 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours

  • 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 value of 15 or higher and other sun

protection measures including: • limit your time in the sun, especially from 10

a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses •

  • Children under 6 months of age: ask a doctor.
Warnings and Precautions (34071-1)

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.

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 51727-6 (51727-6)

Inactive Ingredients

Calcium Aluminum Borosilicate, Silica, Trimethylsiloxysilicate, Calcium Sodium Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Polyglyceryl-10 Pentaisostearate, Boron Nitride, Triethoxycaprylylsilane, Ethylhexylglycerin, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3, Iron Oxides (CI 77492, CI 77491, CI 77499)

Section 51945-4 (51945-4)

(RE) Setting 100% Mineral Powder SPF 35 PA +++

0.12 oz/ 4.25 g

Section 55105-1 (55105-1)

Uses

  • Helps prevent sunburn
  • If used as directed with oher sun protection measures( see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Section 55106-9 (55106-9)

Active Ingredients Purpose

Zinc Oxide 24.7% Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:37.633224 · Updated: 2026-03-14T23:05:30.485285