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#
Contacts and useful links#
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71888-104-01 | 2023-10-27 | C162847 | 48780-1 | 9d75b9d0-9c28-f424-e053-dadaa90a57ce | 60530049-b2b8-3ad6-e053-2991aa0aff80 |
| 71888-104-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9c28-f424-e053-dadaa90a57ce | 60530049-b2b8-3ad6-e053-2991aa0aff80 |
Products#
Every source-derived product name is available through these pages.
- Shield
- Zinc Oxide
- CETEARYL OLIVATE
- COCONUT ALKANES
- PROPANEDIOL
- TRIETHOXYCAPRYLYLSILANE
- TRICAPRYLIN
- CARNAUBA WAX
- XANTHAN GUM
- ARGAN OIL
- GLYCERYL ISOSTEARATE
- COCO-CAPRYLATE
- SODIUM CHLORIDE
- POTASSIUM CETYL PHOSPHATE
- WATER
- ETHYL MACADAMIATE
- GLYCERIN
- SORBITAN OLIVATE
- JOJOBA OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71888-104 | 71888-104-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETEARYL OLIVATE | 58B69Q84JO | IACT |
| COCONUT ALKANES | 1E5KJY107T | IACT |
| PROPANEDIOL | 5965N8W85T | IACT |
| TRIETHOXYCAPRYLYLSILANE | LDC331P08E | IACT |
| TRICAPRYLIN | 6P92858988 | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| XANTHAN GUM | TTV12P4NEE | IACT |
| ARGAN OIL | 4V59G5UW9X | IACT |
| GLYCERYL ISOSTEARATE | HYE7O27HAO | IACT |
| COCO-CAPRYLATE | 4828G836N6 | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| POTASSIUM CETYL PHOSPHATE | 03KCY6P7UT | IACT |
| WATER | 059QF0KO0R | IACT |
| ETHYL MACADAMIATE | ANA2NCS6V1 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITAN OLIVATE | MDL271E3GR | IACT |
| JOJOBA OIL | 724GKU717M | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2785144a-afc9-8862-e063-6394a90aa48a | 60530049-b2b8-3ad6-e053-2991aa0aff80 | 2024-11-22 | Warnings | 2785144a-afc9-8862-e063-6394a90aa48a 60530049-b2b8-3ad6-e053-2991aa0aff80 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
