SPL v1
SPL
SPL Set ID 2c703df8-23af-d630-e063-6294a90a1a24
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
Sorbitan Olivate Hydroxyacetophenone Ferrosoferric Oxide Polyglyceryl-3 Pentaricinoleate Propylene Carbonate Pentylene Glycol Glyceryl Polymethacrylate (300000 Mpa.s) Isohexadecane Lemon Terpenes Coco-caprylate/caprate Magnesium Sulfate Isocyclemone E Propylene Glycol Caprylic/capric Triglyceride Linalool Ferric Oxide Yellow Coco-caprylate Isostearic Acid Water Polyglyceryl-2 Dipolyhydroxystearate Limonene, (+)- Isoamyl Laurate Isododecane Niacinamide Polyhydroxystearic Acid (2300 Mw) Saccharide Isomerate Sodium Citrate Pongamia Pinnata Seed Linalyl Acetate Disteardimonium Hectorite Ferric Oxide Red Citric Acid Palmitoyl Tripeptide-1 Polyglyceryl-3 Diisostearate Hexamethylindanopyran

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, Glyceryl Polymethacrylate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Magnesium Sulfate, Niacinamide, Polyhydroxystearic 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

Principal Display Panel

EMMA LEWISHAM

Sunceutical SPF 50 Mineral Face Cream

ZINC OXIDE MINERAL SUN-ACTIVE

BROAD SPECTRUM SPF 50 SUNSCREEN

50 mL/1.7 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, Glyceryl Polymethacrylate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Magnesium Sulfate, Niacinamide, Polyhydroxystearic 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

EMMA LEWISHAM

Sunceutical SPF 50 Mineral Face Cream

ZINC OXIDE MINERAL SUN-ACTIVE

BROAD SPECTRUM SPF 50 SUNSCREEN

50 mL/1.7 FL. OZ.


Advanced Ingredient Data


Raw Label Data

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