SUNCEUTICAL SPF 50 MINERAL FACE CREAM- zinc oxide cream

Sunceutical SPF 50 Mineral Face Cream by

Drug Labeling and Warnings

Sunceutical SPF 50 Mineral Face Cream by is a Otc medication manufactured, distributed, or labeled by Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Zinc Oxide 20%...Sunscreen

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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

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

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

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.

INGREDIENTS AND APPEARANCE

SUNCEUTICAL SPF 50 MINERAL FACE CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70157-369
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
COCO-CAPRYLATE (UNII: 4828G836N6)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
GLYCERYL POLYMETHACRYLATE (300000 MPA.S) (UNII: 2B25A5KAD6)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
MAGNESIUM SULFATE (UNII: DE08037SAB)
LINALOOL (UNII: D81QY6I88E)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN OLIVATE (UNII: MDL271E3GR)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOSTEARIC ACID (UNII: X33R8U0062)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
IRON OXIDES (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70157-369-02	1 in 1 CARTON	01/21/2025
1	NDC: 70157-369-01	50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 70157-369-04	1 in 1 CARTON	01/21/2025
2	NDC: 70157-369-03	50 mL in 1 CUP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/21/2025

Labeler - Baxter Laboratories Pty. Ltd. (740537709)