Active Ingredients And Purpose
Active Ingredient
Titanium Dioxide
Purpose
Sunscreen
Powder
- Manufacturer
- Oxygen Development LLC | Oxygen Development DR Limited
- Effective date
- 2025-05-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:00:31
Key Label Information#
Uses
Uses
Helps prevent sunburn.
Warnings
Warnings
For external use only
Do not use
• Do not use on damaged or broken skin
Directions And Dosage
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
Other Label Information
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 Ingredient
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).
Package label - Principal display panel
Label Images#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-118-01 | Powder | 100 mg in 1 CUP | POWDER | 100 | 2 | |
| 61354-118-02 | Powder | 1 in 1 CARTON | POWDER | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
- Powder
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61354-118 | 61354-118-01, 61354-118-02 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| MAGNESIUM SILICATE | 9B9691B2N9 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| BORON NITRIDE | 2U4T60A6YD | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| MICA | V8A1AW0880 | IACT |
| BISMUTH OXYCHLORIDE | 4ZR792I587 | IACT |
| ZINC STEARATE | H92E6QA4FV | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | ACTIB |
| TITANIUM DIOXIDE | 15FIX9V2JP | ACTIB |
Complete SPL Sections#
Active Ingredient
Titanium Dioxide
Purpose
Sunscreen
Uses
Helps prevent sunburn.
Warnings
For external use only
Do not use
• Do not use on damaged or broken skin
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.
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
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 Ingredient
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).