EMMA LEWISHAM SUNCEUTICAL SPF 50 MINERAL BODY CREAM- zinc oxide 20% lotion

EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream by

Drug Labeling and Warnings

EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream 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, 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

EMMA LEWISHAM

Sunceutical SPF 50 Mineral Body Cream

ZINC OXIDE MINERAL SUN-ACTIVE

BROAD SPECTRUM SPF 50 SUNSCREEN

100 mL/3.4 FL. OZ.

Sunceutical SPF 50 Mineral Body Cream

ZINC OXIDE MINERAL SUN-ACTIVE

BROAD SPECTRUM SPF 50 SUNSCREEN

100 mL/3.4 FL. OZ.

INGREDIENTS AND APPEARANCE

EMMA LEWISHAM SUNCEUTICAL SPF 50 MINERAL BODY CREAM 
zinc oxide 20% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84981-003
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
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOCYCLEMONE E (UNII: 1GD7ODM28Y)
LEMON TERPENES (UNII: 5DHA4TVW63)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
ISOHEXADECANE (UNII: 918X1OUF1E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE (UNII: 4828G836N6)
ISODODECANE (UNII: A8289P68Y2)
MAGNESIUM SULFATE (UNII: DE08037SAB)
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)
LINALYL ACETATE (UNII: 5K47SSQ51G)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ISOSTEARIC ACID (UNII: X33R8U0062)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL (UNII: D81QY6I88E)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84981-003-01	1 in 1 CARTON	06/01/2025
1		100 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 84981-003-02	1 in 1 CARTON	06/01/2025
2		100 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(84981-003)