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AM Shield plus
zinc oxide · AM Shield plus is an over-the-counter drug containing zinc oxide, made by Grace and Glow MD LLC.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
- + 1 repackager labels
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.
Drug facts
- Generic name
- zinc oxide
- Active ingredients
- Zinc Oxide
- Dosage forms
- Cream
- Label holder
- Grace and Glow MD LLC
- FDA application
- M020
- Label updated
- 02/25/2026
Active ingredients
Zinc Oxide 16%
Purpose
Sunscreen
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.
Directions
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.
Warnings
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.
Keep out of reach of children
Keep out of reach of children
Inactive ingredients
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
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Cream | 160 mg/g | topical | 1 |
Manufacturers and labels
1 FDA label · 1 from repackagers
Repackager labels (1)
- Grace and Glow MD LLC02/25/2026
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing12/10/2025Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw...Blossom Pharmaceuticals · 7 products · cGMP deviations
- Class IIDrugOngoing12/03/2025Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA...CA BOTANA International, Inc. · 8 products · CGMP Deviations
- Class IIDrugOngoing11/26/2025Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777...DermaRite Industries, LLC · CGMP Deviation; manufactured at the same facility where other...
- Class IIDrugOngoing09/17/2025Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl....GRACE & FIRE PTY LTD · 2 products · Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen...
- Class IIDrugOngoing07/16/2025B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint...KABANA SKIN CARE · 4 products · cGMP deviations
AM Shield plus: common questions
- What is AM Shield plus used for?
- 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.
- Is AM Shield plus a prescription drug?
- No. AM Shield plus is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as AM Shield plus?
- Yes. Other FDA-listed products with the same active ingredients include Diaper Rash, Zinc Oxide 20%, SPF 50 Sunscreen Stick, Cream.
- Who makes AM Shield plus?
- Grace and Glow MD LLC lists AM Shield plus with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 02/25/2026 · Label text is shown as published by the manufacturer. Not medical advice