FDA.reportPublic FDA data

Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16

Manufacturer
REJUVA MINERALS INC | Columbia Cosmetics Manufacturing, Inc.
Effective date
2025-01-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:50:34

Label at a glance#

ProductSheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16
Active ingredientZINC OXIDE
Label structure7 sections

Indications and 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

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours 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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. – 2p.m. Wear long-sleeved shirts, pants, hat...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (17.5%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

  • Reapply at least every 2 hours 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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. – 2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • use water resistant sunscreen if swimming or sweating
  • Children under 6 months of age: Ask a doctor.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Oil, Cocos Nucifera (Coconut) Oil, Sorbitan Stearate, Polyglyceryl-10 Laurate, Glycerin*, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Magnesium Sulfate, Gluconolactone, Triethoxycaprylylsilane, Sodium Benzoate, Santalum Album (Sandalwood) Oil, Glycerin, Xanthan Gum, Simmondsia Chinensis (Jojoba) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Virgin Coconut) Oil*, Calcium Gluconate, Sodium Hyaluronate, Palmitoyl Tetrapeptide-7, Palmitoyl Hexapeptide-12. *Certified Organic. May Contain: Iron Oxide CI 77492, Iron Oxide CI 77491, Iron Oxide CI 77499

Questions:

OTC - QUESTIONS SECTION

Call (352) 589-0139

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82328-0012-02024-12-30C16284748780-1f386c64a-38de-0266-e053-dadaa90a7c1aRejuva MInerals Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16 (50 ml / 1.69 oz)
82328-0012-02023-01-30C16284748780-1f386c64a-38de-0266-e053-dadaa90a7c1aRejuva MInerals Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16 (50 ml / 1.69 oz)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82328-0012-0Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 1650 mL in 1 BOTTLE, PUMPCREAM503
82328-0012-1Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 1650 mL in 1 BOTTLE, PUMPCREAM503
82328-0012-1Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 161 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82328-0012SHEER DAILY WEAR FACE PROTECTION MINERAL BASED SUNSCREEN SPF 16 (ZINC OXIDE) CREAM [REJUVA MINERALS INC]3Current NDC, Legacy NDC, 3 package rows20250104_3d83c220-1801-4193-b6a8-c777f412c173.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82328-001282328-0012-0, 82328-0012-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
COCONUT OILQ9L0O73W7LIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
GLUCONOLACTONEWQ29KQ9POTIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM BENZOATEOJ245FE5EUIACT
SANDALWOOD OILX7X01WMQ5FIACT
XANTHAN GUMTTV12P4NEEIACT
JOJOBA OIL724GKU717MIACT
SUNFLOWER OIL3W1JG795YIIACT
CALCIUM GLUCONATESQE6VB453KIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
ZINC OXIDESOI2LOH54ZACTIM
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
WATER059QF0KO0RIACT

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 Daily Wear Face Protection Mineral Based Sunscreen SPF 16ZINC OXIDEREJUVA MINERALS INC3d83c220-1801-4193-b6a8-c777f412c1732025-01-02WarningsExact identifier
ndc (package): 82328-0012-0
ndc (package): 82328-0012-1
ndc (product): 82328-0012
ndc11 (package): 82328001200
ndc11 (package): 82328001201
spl id: 2abea764-571b-b459-e063-6394a90a7c96
spl set id: 3d83c220-1801-4193-b6a8-c777f412c173

Reported adverse events (FAERS/openFDA)#

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