sunceutical spf 50 mineral body cream

sunceutical spf 50 mineral body cream
SPL v1
SPL
SPL Set ID 2c28198b-2027-f0d0-e063-6294a90aa05b
Route
topical
Published
Effective Date 2025-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (20 g)
Inactive Ingredients
polyglyceryl-3 diisostearate sorbitan olivate polyhydroxystearic acid (2300 mw) limonene, (+)- coco-caprylate/caprate pongamia pinnata seed coco-caprylate pentylene glycol hydroxyacetophenone isohexadecane magnesium sulfate isostearic acid sodium citrate polyglyceryl-2 dipolyhydroxystearate polyglyceryl-3 pentaricinoleate linalool citric acid water caprylic/capric triglyceride saccharide isomerate isoamyl laurate isododecane disteardimonium hectorite propylene carbonate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-20
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.
Active Ingredient

Active Ingredient Purpose

Zinc Oxide 20% Sunscreen

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 swallowfield, 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 Dipolyhydroxstearate, Isoamyl Laurate, Pentylene Glycol, Isododecane, Polyglyceryl- 3 Polyricinoleate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Magnesium Sulfate, Polyhydroxystearic Acid, Isostearic Acid, Fragrance, Disteardimonium Hectorite, Hydroxyacetophenone, Pongamia Pinnata Seed Extract, Propylene Carbonate, Saccharide Isomerate, Limonene, Linalool, Citric Acid, Sodium Citrate

Section 51945-4

Emma Lewisham

Sunceutical SPF 50

Mineral Body Cream

Zinc Oxide Mineral Sun-Active

Broad Spectrum SPF 50 Sunscreen

100 mL/ 3.4 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 60561-8

Other information

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

Structured Label Content

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.
Active Ingredient (55106-9)

Active Ingredient Purpose

Zinc Oxide 20% Sunscreen

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
Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowfield, 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 Dipolyhydroxstearate, Isoamyl Laurate, Pentylene Glycol, Isododecane, Polyglyceryl- 3 Polyricinoleate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Magnesium Sulfate, Polyhydroxystearic Acid, Isostearic Acid, Fragrance, Disteardimonium Hectorite, Hydroxyacetophenone, Pongamia Pinnata Seed Extract, Propylene Carbonate, Saccharide Isomerate, Limonene, Linalool, Citric Acid, Sodium Citrate

Section 51945-4 (51945-4)

Emma Lewisham

Sunceutical SPF 50

Mineral Body Cream

Zinc Oxide Mineral Sun-Active

Broad Spectrum SPF 50 Sunscreen

100 mL/ 3.4 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 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: 2026-02-15T12:05:24.979183 · Updated: 2026-03-14T23:07:10.032470