SHEER MINERAL SUNSCREEN- zinc oxide cream

SHEER MINERAL SUNSCREEN by

Drug Labeling and Warnings

SHEER MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Plant Devas Inc. dba evanhealy, Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide (20%)

Purpose

Sunscreen

Uses

Helps prevent sunburn. If used as directed with other skin 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 and as needed.

• Children under 6 months of age: ask a doctor
• Reapply: At least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating

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 am - 2 pm
• Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

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

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Polyglyceryl-6 Distearate, Glycerin, Betaine, Glyceryl Stearate, Aloe Barbadensis Leaf Juice1, Sorbitan Sesquioleate, Caprylhydroxamic Acid (and) Glyceryl Caprylate (and) Glycerin, Diheptyl Succinate (and) Capryloyl Glycerin/Sebacic Acid Copolymer, Polyhydroxystearic Acid, Sodium PCA, Tocopheryl Acetate, Xanthan Gum, Squalane, Allantoin, Bisabolol, Tocopherol, Pongamia Pinnata Seed Extract, Sodium Stearoyl Glutamate, Citric Acid, Sodium Hyaluronate, Glycerin (and) Camellia Sinensis (Green Tea) Leaf Extract1, Glycerin (and) Calendula Officinalis Flower Extract1, Rubus Idaeus (Raspberry) Seed Oil

1 Certified Organic Ingredient

SPL UNCLASSIFIED SECTION

Distributed by

Plant Devas Inc.
Carlsbad, CA 92008

PRINCIPAL DISPLAY PANEL - 60 ML Tube Box

evanhealy

SHEER MINERAL
SUNSCREEN

Calendula &
Raspberry Seed

BROAD SPECTRUM
SPF 30

2 FL OZ (60 ML)

INGREDIENTS AND APPEARANCE

SHEER MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84009-816
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)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Polyglyceryl-6 Distearate (UNII: Z35I17EQOP)
Glycerin (UNII: PDC6A3C0OX)
Betaine (UNII: 3SCV180C9W)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Glyceryl Monocaprylate (UNII: TM2TZD4G4A)
Diheptyl Succinate (UNII: 057N7SS26Y)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Xanthan Gum (UNII: TTV12P4NEE)
Squalane (UNII: GW89575KF9)
Allantoin (UNII: 344S277G0Z)
Levomenol (UNII: 24WE03BX2T)
Tocopherol (UNII: R0ZB2556P8)
Pongamia Pinnata Seed (UNII: C2BRV53B1V)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Raspberry Seed Oil (UNII: 9S8867952A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84009-816-01	1 in 1 BOX	02/12/2024
1		60 mL in 1 TUBE; 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	02/12/2024

Labeler - Plant Devas Inc. dba evanhealy (009744683)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Inc.		189788201	MANUFACTURE(84009-816)