EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream

Manufacturer
EMMA LEWISHAM US, INC. | Baxter Laboratories Pty. Ltd.
Effective date
2025-02-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:54

Label at a glance#

ProductEMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream
Active ingredientZINC OXIDE
Label structure6 sections

Indications and 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

Dosage and administration

• 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-...

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

Active Ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Uses

INDICATIONS & USAGE SECTION

•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

Warnings

WARNINGS SECTION

• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.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.

Main CartonMain Carton

Refill CartonRefill Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Main VesselMain Vessel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunceutical SPF 50 Mineral Face Cream

ZINC OXIDE MINERAL SUN-ACTIVE

BROAD SPECTRUM SPF 50 SUNSCREEN

50 mL/1.7 FL. OZ.

Refill PodRefill Pod

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84981-005-01EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream50 mL in 1 JARLOTION501
84981-005-01EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream1 in 1 CARTONLOTION11
84981-005-02EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream1 in 1 CARTONLOTION11
84981-005-02EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream50 mL in 1 JARLOTION501

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84981-00584981-005-01, 84981-005-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMMA LEWISHAM Sunceutical SPF 50 Mineral Face CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2c703df8-23af-d630-e063-6294a90a1a242025-02-05WarningsExact identifier
ndc (package): 84981-005-01
ndc (package): 84981-005-02
ndc (product): 84981-005
ndc11 (package): 84981000502
ndc11 (package): 84981000501
spl id: 2c703df8-23b0-d630-e063-6294a90a1a24
spl set id: 2c703df8-23af-d630-e063-6294a90a1a24

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.