SPL v1
SPL
SPL Set ID 2d65b2d0-7013-d0ad-e063-6394a90ad4c2
Route
TOPICAL
Published
Effective Date 2025-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Polyglyceryl-3 Pentaricinoleate Isocyclemone E Lemon Terpenes Hydroxyacetophenone Pongamia Pinnata Seed Propylene Carbonate Saccharide Isomerate Isohexadecane Caprylic/capric Triglyceride Coco-caprylate/caprate Sodium Citrate Polyglyceryl-3 Diisostearate Polyhydroxystearic Acid (2300 Mw) Water Coco-caprylate Isododecane Magnesium Sulfate Hexamethylindanopyran Linalyl Acetate Disteardimonium Hectorite Pentylene Glycol Polyglyceryl-2 Dipolyhydroxystearate Isoamyl Laurate Sorbitan Olivate Isostearic Acid Limonene, (+)- Linalool Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Active Ingredient Zinc Oxide 20% Purpose Sunscreen


Medication Information

Description

Active Ingredient Zinc Oxide 20% Purpose Sunscreen

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 51945-4

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
  • Stop use and ask a doctor if rash occurs.
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

Other information

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

Active Ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Inactive Ingredients

Water, Coco-Caprylate/Caprate, Isohexadecane, Caprylic/Capric Triglyceride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, 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

Principal Display Panel

EMMA LEWISHAM

Sunceutical SPF 50 Mineral Body Cream

ZINC OXIDE MINERAL SUN-ACTIVE

BROAD SPECTRUM SPF 50 SUNSCREEN

100 mL/3.4 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 51945-4 (51945-4)

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
  • Stop use and ask a doctor if rash occurs.
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

Other information

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

Active Ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Inactive Ingredients

Water, Coco-Caprylate/Caprate, Isohexadecane, Caprylic/Capric Triglyceride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

EMMA LEWISHAM

Sunceutical SPF 50 Mineral Body Cream

ZINC OXIDE MINERAL SUN-ACTIVE

BROAD SPECTRUM SPF 50 SUNSCREEN

100 mL/3.4 FL. OZ.


Advanced Ingredient Data


Raw Label Data

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