Active Ingredient
Titanium Dioxide
Powder
FDA Label NDC 61354-190
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development Llc for the product Powder (NDC 61354-190). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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).
Package Label - Principal Display Panel
61354-190-01_aw (Aw Uc)
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