FDA.reportPublic FDA data

Mychelle Dermaceuticals Sun Shield Clear Spray SPF 30 Mineral Continuous Spray

Manufacturer
Bell International Laboratories, Inc.
Effective date
2021-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:56:24

Label at a glance#

ProductSun Shield Clear SPF 30 Broad Spectrum Mineral Continuous
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

Shake well. Spray liberally and spread evenly by hand 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Do not spray directly on face. Spray on hands and apply to face. Avoid inhaling or exposing others to spray. 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: Spe...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide..............12%

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

  • Do not puncture or incinerate can
  • Keep away from fire and flames
  • For external use only.
  • Do not spray directly on face
  • Do not use on damaged or broken skin.
  • When using this rpoduct keep out of eyes. Rinse with water ro 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

  • Shake well. Spray liberally and spread evenly by hand 15 minutes before sun exposure.
  • Hold container 4 to 6 inches from skin to apply.
  • Do not spray directly on face. Spray on hands and apply to face.
  • Avoid inhaling or exposing others to spray.
  • 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Weat long-sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco Glucoside, Glycerin, Heptyl Undecylenate, Jojoba Esters, Methyl Dihydroabietate, Triethyl Citrate, Vanila Planifolia Fruit Extract, Water

Other Information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.
  • Store at temperatures below 90oF
  • May stain some fabrics.

6 oz label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6 oz label6 oz label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76150-142-132023-01-30C16284748780-1f386c649-cd20-0266-e053-dadaa90a7c1aMychelle Dermaceuticals Sun Shield Clear Spray SPF 30 Mineral Continuous Spray

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76150-142SUN SHIELD CLEAR SPF 30 BROAD SPECTRUM MINERAL CONTINUOUS (ZINC OXIDE SPF 30 MINERAL) SPRAY [BELL INTERNATIONAL LABORATORIES, INC.]2Legacy NDC20210115_33d5265e-b4f9-2d47-e054-00144ff88e88.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
76150-14276150-142-13

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
ZINC OXIDESOI2LOH54ZACTIB
SAFFLOWER OIL65UEH262ISIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERINPDC6A3C0OXIACT
HEPTYL UNDECYLENATEW77QUB6GXOIACT
VANILLA PLANIFOLIA FLOWER33NF0M2062IACT
WATER059QF0KO0RIACT
BENTONITEA3N5ZCN45CIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

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
b8deab1b-2811-5e98-e053-2995a90a10c633d5265e-b4f9-2d47-e054-00144ff88e882021-01-14WarningsExact identifier
spl id: b8deab1b-2811-5e98-e053-2995a90a10c6
spl set id: 33d5265e-b4f9-2d47-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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