FDA.reportPublic FDA data

SHEER MINERAL SUNSCREEN

Manufacturer
Plant Devas Inc. dba evanhealy | Sun Deep Inc.
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:40

Label at a glance#

ProductSHEER MINERAL SUNSCREEN
Active ingredientZinc Oxide
Label structure11 sections

Indications and 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.

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (20%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

  • For external use only
  • Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes
  • Rinse with water to remove
  • Stop use and ask a doctor if rash occurs

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

evanhealy

SHEER MINERAL
SUNSCREEN

Calendula &
Raspberry Seed

BROAD SPECTRUM
SPF 30

2 FL OZ (60 ML)

PRINCIPAL DISPLAY PANEL - 60 ML Tube Box
PRINCIPAL DISPLAY PANEL - 60 ML Tube Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84009-816-01SHEER MINERAL SUNSCREEN1 in 1 BOXCREAM12
84009-816-01SHEER MINERAL SUNSCREEN60 mL in 1 TUBECREAM602
84009-816-02SHEER MINERAL SUNSCREEN30 mL in 1 BOTTLE, GLASSCREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84009-816SHEER MINERAL SUNSCREEN (ZINC OXIDE) CREAM [PLANT DEVAS INC. DBA EVANHEALY]2Current NDC, 3 package rows20250406_f620ef44-f30c-4cc9-bc82-28dc4a47a8da.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84009-81684009-816-01, 84009-816-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Polyglyceryl-6 DistearateZ35I17EQOPIACT
GlycerinPDC6A3C0OXIACT
Betaine3SCV180C9WIACT
Glyceryl Monostearate230OU9XXE4IACT
Aloe Vera LeafZY81Z83H0XIACT
Sorbitan Sesquioleate0W8RRI5W5AIACT
Caprylhydroxamic AcidUPY805K99WIACT
Glyceryl MonocaprylateTM2TZD4G4AIACT
Diheptyl Succinate057N7SS26YIACT
Sodium Pyrrolidone Carboxylate469OTG57A2IACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Xanthan GumTTV12P4NEEIACT
SqualaneGW89575KF9IACT
Allantoin344S277G0ZIACT
Levomenol24WE03BX2TIACT
TocopherolR0ZB2556P8IACT
Pongamia Pinnata SeedC2BRV53B1VIACT
Sodium Stearoyl Glutamate65A9F4P024IACT
Citric Acid Monohydrate2968PHW8QPIACT
Hyaluronate SodiumYSE9PPT4THIACT
Green Tea LeafW2ZU1RY8B0IACT
Calendula Officinalis FlowerP0M7O4Y7YDIACT
Raspberry Seed Oil9S8867952AIACT

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
SHEER MINERAL SUNSCREENZINC OXIDEPlant Devas Inc. dba evanhealyf620ef44-f30c-4cc9-bc82-28dc4a47a8da2025-04-02WarningsExact identifier
ndc (package): 84009-816-02
ndc (package): 84009-816-01
ndc (product): 84009-816
ndc11 (package): 84009081601
ndc11 (package): 84009081602
spl id: 59a8d775-c366-4056-a985-e80f47f4bfe3
spl set id: f620ef44-f30c-4cc9-bc82-28dc4a47a8da

Reported adverse events (FAERS/openFDA)#

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