FDA.reportPublic FDA data

Sunceutical SPF 50 Mineral Glow Serum

Manufacturer
Baxter Laboratories Pty. Ltd.
Effective date
2025-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:33

Label at a glance#

ProductSunceutical SPF 50 Mineral Glow Serum
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Zinc Oxide 20% Suncreen

OTC - PURPOSE SECTION

Uses

  • Helps prevent
  • If used as directed with other sun protect 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 the container from excessive heat and direct

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, Mica, Glyceryl Polymethacrylate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Titantium Dioxide Iron Oxides, Magnesium Sulfate, Polyhydroxystearic Acid, Saccharide Isomerate, Isostearic Acid, Fragrance, Disteardimonium Hectorite, Hydroxyacetophenone, Propylene Glycol, Pongamia Pinnata Seed Extract, Propylene Carbonate, Limonene, Citric Acid, Sodium Citrate, Linalool, Palmitoyl Tripeptide-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Emma Lewisham

Sunceutical SPF 50 Mineral Glow Serum

Zinc Oxide Mineral Sun-Active

Broad Spectrum SPF 50 Sunscreen

30mL/ 1 FL. OZ.

sunceutical spf mineral glow mainsunceutical spf mineral glow main

Sunceutical SPF 50 mineral glow refillSunceutical SPF 50 mineral glow refill

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
70157-367-01Sunceutical SPF 50 Mineral Glow Serum30 mL in 1 JARCREAM301
70157-367-02Sunceutical SPF 50 Mineral Glow Serum1 in 1 CARTONCREAM11
70157-367-03Sunceutical SPF 50 Mineral Glow Serum30 mL in 1 CUPCREAM301
70157-367-04Sunceutical SPF 50 Mineral Glow Serum1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70157-367SUNCEUTICAL SPF 50 MINERAL GLOW SERUM (ZINC OXIDE) CREAM [BAXTER LABORATORIES PTY. LTD.]1Current NDC, 4 package rows20250125_2c2c9b67-9588-efbe-e063-6294a90aa6a4.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70157-36770157-367-01, 70157-367-02, 70157-367-03, 70157-367-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
IRON OXIDES1K09F3G675IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
PENTYLENE GLYCOL50C1307PZGIACT
WATER059QF0KO0RIACT
COCO-CAPRYLATE4828G836N6IACT
SORBITAN OLIVATEMDL271E3GRIACT
ISOSTEARIC ACIDX33R8U0062IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
ZINC OXIDESOI2LOH54ZACTIB
ISOHEXADECANE918X1OUF1EIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ISOAMYL LAURATEM1SLX00M3MIACT
MICAV8A1AW0880IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
LIMONENE, (+/-)-9MC3I34447IACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
PROPYLENE CARBONATE8D08K3S51EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM SULFATEDE08037SABIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
ISODODECANEA8289P68Y2IACT
GLYCERYL POLYMETHACRYLATE (300000 MPA.S)2B25A5KAD6IACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
LINALOOL, (+/-)-D81QY6I88EIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT

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
Sunceutical SPF 50 Mineral Glow SerumZINC OXIDEBaxter Laboratories Pty. Ltd.2c2c9b67-9588-efbe-e063-6294a90aa6a42025-01-20WarningsExact identifier
ndc (package): 70157-367-04
ndc (package): 70157-367-03
ndc (package): 70157-367-02
ndc (package): 70157-367-01
ndc (product): 70157-367
ndc11 (package): 70157036703
ndc11 (package): 70157036702
ndc11 (package): 70157036704
ndc11 (package): 70157036701
spl id: 2c2c9b67-9589-efbe-e063-6294a90aa6a4
spl set id: 2c2c9b67-9588-efbe-e063-6294a90aa6a4

Reported adverse events (FAERS/openFDA)#

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