Sunceutical Spf 50 Mineral Face Cream

Sunceutical Spf 50 Mineral Face Cream
SPL v1
SPL
SPL Set ID 2c408728-a1de-d51e-e063-6294a90ade0b
Route
TOPICAL
Published
Effective Date 2025-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Water Hydroxyacetophenone Caprylic/capric Triglyceride Isoamyl Laurate Coco-caprylate Pentylene Glycol Disteardimonium Hectorite Isododecane Glyceryl Polymethacrylate (300000 Mpa.s) Isohexadecane Polyglyceryl-2 Dipolyhydroxystearate Magnesium Sulfate Linalool Palmitoyl Tripeptide-1 Polyglyceryl-3 Diisostearate Polyglyceryl-3 Pentaricinoleate Citric Acid Sodium Citrate Propylene Glycol Sorbitan Olivate Niacinamide Isostearic Acid Limonene, (+)- Polyhydroxystearic Acid (2300 Mw) Saccharide Isomerate Pongamia Pinnata Seed Propylene Carbonate Coco-caprylate/caprate Iron Oxides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-21
Description

Active ingredient Purpose Zinc Oxide 20%...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 liberally 15 minutes before sun exposure
  • 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 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 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 Purpose Zinc Oxide 20%...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

Water, Coco-Caprylate/Caprate, Isohexadecane, Caprylic/Capric Triglyceride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Isoamyl Laurate, Pentylene Glycol, Isododecane, Polyglyceryl-3 Polyricinoleate, Glyceryl Polymethacrylate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Magnesium Sulfate, Niacinamide, Polyhyroxystearic Acid, Saccharide Isomerate, Isostearic Acid, Fragrance, Disteardimonium Hectorite, Hydroxyacetophenone, Propylene Glycol, Pongamia Pinnata Seed Extract, Propylene Carbonate, Iron oxides, Limonene, Citric Acid, Sodium Citrate, Linalool, Palmitoyl Tripeptide-1

Section 51945-4

Emma Lewisham

Sunceutical SPF 50 Mineral Face Cream

Zinc Oxide Mineral Sun-Active

Broad Spectrum SPF 50 Sunscreen

50mL/ 1.7 FL. OZ.

Section 55105-1

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 55106-9

Active ingredient Purpose

Zinc Oxide 20%...Sunscreen

Section 60561-8

Other information

  • Protect the product in this container from excessive heat and direct sun

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

  • Apply liberally 15 minutes before sun exposure
  • 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 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 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
  • 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

Water, Coco-Caprylate/Caprate, Isohexadecane, Caprylic/Capric Triglyceride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Isoamyl Laurate, Pentylene Glycol, Isododecane, Polyglyceryl-3 Polyricinoleate, Glyceryl Polymethacrylate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Magnesium Sulfate, Niacinamide, Polyhyroxystearic Acid, Saccharide Isomerate, Isostearic Acid, Fragrance, Disteardimonium Hectorite, Hydroxyacetophenone, Propylene Glycol, Pongamia Pinnata Seed Extract, Propylene Carbonate, Iron oxides, Limonene, Citric Acid, Sodium Citrate, Linalool, Palmitoyl Tripeptide-1

Section 51945-4 (51945-4)

Emma Lewisham

Sunceutical SPF 50 Mineral Face Cream

Zinc Oxide Mineral Sun-Active

Broad Spectrum SPF 50 Sunscreen

50mL/ 1.7 FL. OZ.

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Active ingredient Purpose

Zinc Oxide 20%...Sunscreen

Section 60561-8 (60561-8)

Other information

  • Protect the product in this container from excessive heat and direct sun

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:24.893950 · Updated: 2026-03-14T23:07:07.673818