EMMA LEWISHAM SUNCEUTICAL SPF 50 MINERAL GLOW SERUM- zinc oxide 20% lotion

EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow Serum by

Drug Labeling and Warnings

EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow Serum by is a Otc medication manufactured, distributed, or labeled by EMMA LEWISHAM US, INC., Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 20 %

Purpose

Sunscreen

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

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

Stop use and ask a doctor if rash occurs.

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

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 information

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

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, Titanium 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

PRINCIPAL DISPLYA PANEL

EMMA LEWISHAM

Sunceutical SPF 50 Mineral Glow Serum

ZINC OXIDE MINERAL SUN-ACTIVE

BROAD SPECTRUM SPF 50 SUNSCREEN

30 mL/1 FL. OZ.

Sunceutical SPF 50 Mineral Glow Serum

ZINC OXIDE MINERAL SUN-ACTIVE

BROAD SPECTRUM SPF 50 SUNSCREEN

30 mL/1 FL. OZ.

INGREDIENTS AND APPEARANCE

EMMA LEWISHAM SUNCEUTICAL SPF 50 MINERAL GLOW SERUM 
zinc oxide 20% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84981-002
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)
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
CITRIC ACID (UNII: 2968PHW8QP)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM SULFATE (UNII: DE08037SAB)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISOCYCLEMONE E (UNII: 1GD7ODM28Y)
LINALYL ACETATE (UNII: 5K47SSQ51G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
COCO-CAPRYLATE (UNII: 4828G836N6)
ISODODECANE (UNII: A8289P68Y2)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
MICA (UNII: V8A1AW0880)
SORBITAN OLIVATE (UNII: MDL271E3GR)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LINALOOL (UNII: D81QY6I88E)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERYL POLYMETHACRYLATE (300000 MPA.S) (UNII: 2B25A5KAD6)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
LEMON TERPENES (UNII: 5DHA4TVW63)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84981-002-01	1 in 1 CARTON	06/01/2025
1		30 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 84981-002-02	1 in 1 CARTON	06/01/2025
2		30 mL in 1 JAR; 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	06/01/2025

Labeler - EMMA LEWISHAM US, INC. (119326604)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty. Ltd.		740537709	manufacture(84981-002)