Active Ingredient
Titanium Dioxide 17%. Purpose: Sunscreen
Cream
FDA Label NDC 61354-080
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 Cream (NDC 61354-080). 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, stop use, keep out of reach of children, 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 if used as directed with other sun protection measures. Decreased the risk of skin cancer and early skin aging caused by the sun
Warnings
for external use only
Do Not Use
on damaged or broken skin
When Using
this product, keep out of eyes. Rinse with water to remove
Stop Use
and ask a doctor if rash occurs
Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a poison control center right away
Directions
for sunscreen use:
- 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
Sun Protection Measures
spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10am - 2pm
- wear long-slevve shirts, pants, hats, and sunglasses
Inactive Ingredients
isododecane, disteardimonium hectorite, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, propylene carbonate, silica, Trimethylsiloxysilicate, Dipalmitoyl Hydroxyproline, Mangifera Indica (Mango) Seed Butter, Carthamus Tinctorius (Safflower) Seed Oil, Camellia Oleifera Leaf Extract, Acrylates Copolymer, Diacetyl Boldine, Calcium Sodium Borosilicate, Calcium Aluminum Borosilicate, tin oxide, phenoxyethanol, may contain: mica, carmine, titanium dioxide, iron oxides, Bismuth Oxychloride,chromium hydroxide green, chromium oxide greens, ferric fenocyanide, manganese violet, ultramarines
Other Information
protect this product from excessive heat and direct sun
Package Label
61354-080-07_aw (Art 70759)
* Please review the disclaimer below.
