Checked
Powder
titanium dioxide · Powder is an over-the-counter drug containing titanium dioxide, made by Oxygen Development LLC.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
Helps prevent sunburn.
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing09/30/2026MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei...SHANTOU Qiwei industrial Co., Ltd · cGMP Deviations
- Class IIDrugOngoing12/31/2025Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx...Merck Sharp & Dohme LLC · Presence of particulate matter: potential presence of metal...
- Class IIDrugOngoing12/03/2025Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube...CA BOTANA International, Inc. · 2 products · CGMP Deviations
- Class IIDrugOngoing10/15/2025Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC...GenoGenix LLC · Lack of Assurance of Sterility
- Class IIDrugOngoing07/23/2025Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL...A.P. Deauville, LLC · CGMP Deviations
Active ingredients
Titanium Dioxide
Purpose
Sunscreen
Uses
Helps prevent sunburn.
Directions
Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months: ask a doctor
Warnings
For external use only
Do not use
- Do not use on damaged or broken skin
When using this product
When using When using this product, keep out of eyes. Rinse with water to remove
Keep out of reach of children
- Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Other information
Protect this product from excessive heat and direct sun
- In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.
Inactive ingredients
Mica, Caprylic/Capric Triglyceride, Boron Nitride, Bismuth Oxychloride, Zinc Stearate, Magnesium Silicate, Sodium Starch Octenylsuccinate, Mannitol, Sodium Gluconate, Citric Acid, Sodium Citrate, Waltheria Indica Leaf Extract, Dextrin, Ferulic Acid, Lactic Acid (L), Butyrospermum Parkii (Shea) Butter, Retinol, Ceramide AP, Silica, Tocopheryl Acetate, Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambusa Vulgaris Leaf/Stem Extract, Magnesium Carbonate, Iron Oxides (CI 77491, CI 77492, CI 77499), May Contain: Titanium Dioxide (CI 77891), Ultramarines (CI 77007).
Forms and strengths
From the FDA NDC Directory · 6 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Powder | 1.75 mg/100mg / 10 mg/100mg | topical | 4 |
| Powder | 10 mg/100mg | topical | 2 |
Manufacturers and labels
6 FDA labels
- Oxygen Development LLCShown hereM020 · Label 03/17/2026 · NDC 61354-189Full label
- Oxygen Development LLCM020 · Label 03/17/2026 · NDC 61354-190Full label
- Oxygen Development LLCM020 · Label 10/22/2025 · NDC 61354-188Full label
- Oxygen Development LLCM020 · Label 09/05/2025 · NDC 61354-117Full label
- Oxygen Development LLCM020 · Label 09/05/2025 · NDC 61354-119Full label
- Oxygen Development LLCM020 · Label 05/07/2025 · NDC 61354-118Full label
Powder: common questions
- What is Powder used for?
- Helps prevent sunburn.
- Is Powder a prescription drug?
- No. Powder is sold over the counter (OTC) without a prescription.
- Who makes Powder?
- Oxygen Development LLC lists Powder with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 03/17/2026 · Label text is shown as published by the manufacturer. Not medical advice