Shield

Manufacturer
Bellus Medical, LLC
Effective date
2024-11-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:48:50

Label at a glance#

ProductShield
Active ingredientZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 21%

OTC - PURPOSE SECTION

Sunscreen

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. Stop use and ask doctor if rash and irritation develops and lasts.

Avoid contact with eyes if product gets into eyes rinse thoroughly with water.

If swallowed get medical help or contact poison control center right away.

INDICATIONS & USAGE SECTION

Evenly apply to skin before
exposure to sun and as needed.
• Children under 6 months,
ask doctor.
• Protect this product from
excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Argania Spinosa Kernel Oil, Caprylic/
Capric Triglyceride, Cetearyl
Alcohol, Cetearyl Glucoside,Cetearyl
Olivate, Coco-Caprylate/-
Caprate , Cocoglycerides, Coconut
Alkanes , Copernicia Cerifera
(Carnauba) Wax, Diethylhexanoate,
Ethyl Macadamiate, Glycerin, Glyceryl
Caprylate, Glyceryl Isostearate,
Glyceryl Undecylenate, Iron
Oxides, Lysolecithin, Neopentyl
Glycol, p-Anisic acid, Polyglyceryl-3
Polyricinoleate, Polyglyceryl-3
Stearate, Polyhydroxystearic Acid,
Potassium Cetyl Phosphate, Propanediol,
Simmondsia Chinensis
(Jojoba) Seed Oil, Sodium Chloride,
Sorbitan Olivate, Tocopherol Linoleate
/ Oleate, Triethoxycaprylylsilane,
Water (Aqua), Xanthan Gum.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - QUESTIONS SECTION

Call 888.372.3982

Distributed by: Crown Aesthetics

Dallas, TX 75244

All registered trademarks belong to Crown Aesthetics.

DOSAGE & ADMINISTRATION SECTION

Helps prevent sunburn and photodamage caused by UVA/UVB exposure
Higher SPF gives more sunburn protection
If used as directed with other sun protection measures (see DIRECTIONS), decreases the risks of skin cancer and early skin aging caused by the sun

RECENT MAJOR CHANGES SECTION

Updated to include dosage and administration information. No changes to use of the product, adding section.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SF_30ml_Box_SHIELD_FINAL_v3_160321 JPEG_Page_1SF_30ml_Box_SHIELD_FINAL_v3_160321 JPEG_Page_1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71888-104-012023-10-27C16284748780-19d75b9d0-9c28-f424-e053-dadaa90a57ce60530049-b2b8-3ad6-e053-2991aa0aff80
71888-104-012020-01-31C16284748780-19d75b9d0-9c28-f424-e053-dadaa90a57ce60530049-b2b8-3ad6-e053-2991aa0aff80

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71888-10471888-104-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
2785144a-afc9-8862-e063-6394a90aa48a60530049-b2b8-3ad6-e053-2991aa0aff802024-11-22WarningsExact identifier
spl id: 2785144a-afc9-8862-e063-6394a90aa48a
spl set id: 60530049-b2b8-3ad6-e053-2991aa0aff80

Reported adverse events (FAERS/openFDA)#

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