Concealer Broad Spectrum Sunscreen SPF 30

Manufacturer
Epione Medical Corporation | VEGE-KURL, INC
Effective date
2018-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:10

Label at a glance#

ProductConcealer Broad Spectrum Sunscreen SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Titanium Dioxide 5.00%

Zinc Oxide 10.00%

OTC - PURPOSE SECTION

Uses:

Helps prevent sunburn
If used as direct with other sun protection measures (see  Directions), decreases the risk of skin cancer and early aging caused by the sun.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Stop use/ contact a doctor if rash occurs

WARNINGS SECTION

Warnings:

For external use only
Do not use on damaged or broken skin
Avoid contact with eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION SECTION

Directions:

Apply evenly 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children Under 6 months: Ask a doctor.

Sun Protection Measures:

Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10a.m.-2p.m.
Wear long-sleeved shirt, pants, hats, and sunglasses
Reapply at least every 2 hours

INACTIVE INGREDIENT SECTION

Water, Coconut Alkanes, Octyldodecyl Neopentanoate, Butylene Glycol, C12-15 Alkyl Benzoate, Polysorbate 60, Cyclopentasiloxane, Dimethicone, Cetearyl Alcohol, Glycerine, Polysorbate 60, Polyacrylamide, Polyhydroxystearic Acid, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, C13-14 Isoparaffin, Coco-Caprylate/Caprate, Stearic Acid, Acrylates/C10-30 Alklyl Acrylates Crosspolymer, Ethylhexylglycerin, Alumina, Xanthan Gum, Laureth-7, Triethanolamine, Iron Oxides( CI 77499, CI 77491, CI77492).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Epione

Concealer Broad Spectrum SPF 30+

1.0 FL OZ (30mL)

frontfront

back 1back 1

back 2back 2

back 3back 3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70698-004-012020-01-31C16284748780-19d75b9d0-372d-f424-e053-dadaa90a57ceConcealer Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70698-004-01Concealer Broad Spectrum Sunscreen SPF 3030 mL in 1 BOTTLECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70698-004CONCEALER BROAD SPECTRUM SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EPIONE MEDICAL CORPORATION]1Legacy NDC, 1 package rows20180707_701f42dc-6935-5cea-e053-2a91aa0ac8eb.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70698-00470698-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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
701f42dc-6936-5cea-e053-2a91aa0ac8eb701f42dc-6935-5cea-e053-2a91aa0ac8eb2018-07-03WarningsExact identifier
spl id: 701f42dc-6936-5cea-e053-2a91aa0ac8eb
spl set id: 701f42dc-6935-5cea-e053-2a91aa0ac8eb

Reported adverse events (FAERS/openFDA)#

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