FDA.reportPublic FDA data

EMMA LEWISHAM Sunceutical SPF 50 Mineral Body 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 Body 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-sleeved sh...

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, 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

PACKAGE LABEL.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.

Main CartonMain Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Refill CartonRefill Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Main VesselMain Vessel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunceutical SPF 50 Mineral Body Cream

ZINC OXIDE MINERAL SUN-ACTIVE

BROAD SPECTRUM SPF 50 SUNSCREEN

100 mL/3.4 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
84981-003-01EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream100 mL in 1 JARLOTION1001
84981-003-01EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream1 in 1 CARTONLOTION11
84981-003-02EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream1 in 1 CARTONLOTION11
84981-003-02EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream100 mL in 1 JARLOTION1001

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84981-00384981-003-01, 84981-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ISOCYCLEMONE E1GD7ODM28YIACT
LEMON TERPENES5DHA4TVW63IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
PROPYLENE CARBONATE8D08K3S51EIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
ISOHEXADECANE918X1OUF1EIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
SODIUM CITRATE1Q73Q2JULRIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
COCO-CAPRYLATE4828G836N6IACT
ISODODECANEA8289P68Y2IACT
MAGNESIUM SULFATEDE08037SABIACT
HEXAMETHYLINDANOPYRAN14170060ATIACT
LINALYL ACETATE5K47SSQ51GIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
ISOAMYL LAURATEM1SLX00M3MIACT
SORBITAN OLIVATEMDL271E3GRIACT
ISOSTEARIC ACIDX33R8U0062IACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOLD81QY6I88EIACT
CITRIC ACID2968PHW8QPIACT

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 Body CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2d65b2d0-7013-d0ad-e063-6394a90ad4c22025-02-05WarningsExact identifier
ndc (package): 84981-003-02
ndc (package): 84981-003-01
ndc (product): 84981-003
ndc11 (package): 84981000301
ndc11 (package): 84981000302
spl id: 2d65b2d0-7014-d0ad-e063-6394a90ad4c2
spl set id: 2d65b2d0-7013-d0ad-e063-6394a90ad4c2

Reported adverse events (FAERS/openFDA)#

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