OTC - ACTIVE INGREDIENT SECTION
Zinc Oxide 16%
AM Shield plus
- Manufacturer
- Grace and Glow MD LLC | Fragrance Manufacturing Inc. | Custom Analytics LLC | Fallien Cosmeceuticals Ltd.
- Effective date
- 2026-02-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:47:11
Label at a glance#
ProductAM Shield plus
Active ingredientZINC OXIDE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Sunscreen
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 SECTION
For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
DOSAGE & ADMINISTRATION SECTION
Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.
INACTIVE INGREDIENT SECTION
Caprylic/Capric Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer
OTHER SAFETY INFORMATION
Protect this product from excessive heat and direct sun
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87271-226-50 | AM Shield plus | 50 g in 1 BOTTLE, PUMP | CREAM | 50 | 1 |
Products#
Every source-derived product name is available through these pages.
- AM Shield plus
- Zinc Oxide
- CYCLOPENTASILOXANE
- CERAMIDE 3
- DIMETHICONOL (2000 CST)
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
- PEG-10 DIMETHICONE (600 CST)
- HYDROGEN DIMETHICONE (20 CST)
- ALPHA-TOCOPHEROL ACETATE
- DIMETHICONE
- CAPRYLIC/CAPRIC TRIGLYCERIDE
- DIMETHICONE CROSSPOLYMER
- CYCLOHEXASILOXANE
- POLYHYDROXYSTEARIC ACID (2300 MW)
- TETRAHEXYLDECYL ASCORBATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87271-226 | 87271-226-50 |
| 58892-226 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| AM Shield plus | ZINC OXIDE | Grace and Glow MD LLC | 4ba7c282-c68e-8719-e063-6394a90a3814 | 2026-02-25 | Warnings | 87271-226-50 87271-226 87271022650 4ba7c282-c68f-8719-e063-6394a90a3814 4ba7c282-c68e-8719-e063-6394a90a3814 |
| Proceuticals Private Label by TiZO non-tinted replenishing daily protection | ZINC OXIDE | Fallien Cosmeceuticals, Ltd | 2203ea22-d12a-99fe-e063-6394a90aca9f | 2024-09-13 | Warnings | 58892-226 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.