FDA.reportPublic FDA data

Sunceutical SPF 50 Mineral Face Cream

Manufacturer
Baxter Laboratories Pty. Ltd.
Effective date
2026-08-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-08 02:01:47

Label at a glance#

ProductSunceutical SPF 50 Mineral Face Cream
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Zinc Oxide 20%...Sunscreen

OTC - PURPOSE SECTION

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

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.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

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, Polyhyroxystearic 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Emma Lewisham

Sunceutical SPF 50 Mineral Face Cream

Zinc Oxide Mineral Sun-Active

Broad Spectrum SPF 50 Sunscreen

50mL/ 1.7 FL. OZ.

Mineral Face cream main 12 2024Mineral Face cream main 12 2024

sunceutical SPF 50 Mineral Face Cream refillsunceutical SPF 50 Mineral Face Cream refill

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-139421907629254GTIN-13: 9421907629254
EAN-13: 9421907629254
GTIN storage (14 digits): 09421907629254		US Sunceutical SPF 50 Mineral Face Creme Main Carton Dec 2024.jpg
BarcodeEAN-139421907629261GTIN-13: 9421907629261
EAN-13: 9421907629261
GTIN storage (14 digits): 09421907629261		US Sunceutical SPF 50 Mineral Face Creme Refill Carton Dec 2024.jpg

DailyMed Product Concepts#

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

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
70157-36970157-369-01, 70157-369-02, 70157-369-03, 70157-369-04, 70157-369-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ISOAMYL LAURATEM1SLX00M3MIACT
COCO-CAPRYLATE4828G836N6IACT
PENTYLENE GLYCOL50C1307PZGIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ISODODECANEA8289P68Y2IACT
GLYCERYL POLYMETHACRYLATE (300000 MPA.S)2B25A5KAD6IACT
ISOHEXADECANE918X1OUF1EIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
MAGNESIUM SULFATEDE08037SABIACT
LINALOOLD81QY6I88EIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
CITRIC ACID2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN OLIVATEMDL271E3GRIACT
NIACINAMIDE25X51I8RD4IACT
ISOSTEARIC ACIDX33R8U0062IACT
LIMONENE, (+)-GFD7C86Q1WIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
PROPYLENE CARBONATE8D08K3S51EIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
FERRIC OXIDE RED1K09F3G675IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-01-21full-release2026-06-01 00:53:27

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
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsExact identifier
ndc (package): 70157-369-05
ndc (package): 70157-369-03
ndc (package): 70157-369-04
ndc (package): 70157-369-02
ndc (package): 70157-369-01
ndc (product): 70157-369
ndc11 (package): 70157036903
ndc11 (package): 70157036905
ndc11 (package): 70157036902
ndc11 (package): 70157036904
ndc11 (package): 70157036901
spl id: 5a5bb1b1-67c1-0ec4-e063-6294a90a2a37
spl set id: 2c408728-a1de-d51e-e063-6294a90ade0b

Reported adverse events (FAERS/openFDA)#

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