FDA.reportPublic FDA data

Sun Shield Clear

Manufacturer
Bell International Laboratories, Inc.
Effective date
2021-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:54

Label at a glance#

ProductSun Shield Clear SPF 50 Broad Spectrum
Active ingredientZINC OXIDE
Label structure9 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 and evenly 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying At least every 2 hours. Children under 6 months: 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 borad spectrum SPF of 15 or higher and other sun p...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide........17%

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 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 and irritation develops and lasts.

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 and evenly 15 minutes before sun exposure.
  • Reapply:
    • After 80 minutes of swimming or sweating.
    • Immediately after towel drying
    • At least every 2 hours.
    • Children under 6 months: 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 borad spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Bisabolol, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca Seed Oil, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Octyldodecyl Olivate, Oryza Sativa (Rice) Bran Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

May stain some fabrics.

Shadow box artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

shadow box artworkshadow box artwork

stick front label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

front labelfront label

stick back label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back labelback label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76150-143-252023-01-30C16284748780-1f386c64a-2040-0266-e053-dadaa90a7c1aMychelle Dermaceuticals Sun Shield Clear SPF 50 Mineral Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76150-143-25Sun Shield ClearSPF 50 Broad Spectrum15 mL in 1 TUBESTICK152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76150-143SUN SHIELD CLEAR SPF 50 BROAD SPECTRUM (ZINC OXIDE MINERAL SPF 50) STICK [BELL INTERNATIONAL LABORATORIES, INC.]2Legacy NDC, 1 package rows20210115_33c532f4-c346-1c7c-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76150-14376150-143-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
CALOPHYLLUM TACAMAHACA SEED OIL05G85L61OEIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CANDELILLA WAXWL0328HX19IACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
RICE BRAN OILLZO6K1506AIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
ZINC OXIDESOI2LOH54ZACTIB
LEVOMENOL24WE03BX2TIACT
GAMMA ORYZANOLSST9XCL51MIACT
AVOCADO OIL6VNO72PFC1IACT
JOJOBA OIL724GKU717MIACT
COCOA BUTTER512OYT1CRRIACT
TOCOPHEROLR0ZB2556P8IACT

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
b8de9bed-21ab-134d-e053-2a95a90a463333c532f4-c346-1c7c-e054-00144ff8d46c2021-01-14WarningsExact identifier
spl id: b8de9bed-21ab-134d-e053-2a95a90a4633
spl set id: 33c532f4-c346-1c7c-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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