Active Ingredients
Titanium Dioxide 4.55%
Zinc Oxide 3.5%
Cream
FDA Label NDC 61354-051
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 61354-051). 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 ingredients, purpose, uses, warnings, otc - stop use, otc - do not use, otc - when using, otc - 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 (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only
Otc - Stop Use
Stop use and ask doctor if rash occurs.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Shake before use.
- Apply liberally 15 minutes before sun exposure.
- Use a water-resistant sunscreen of 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 our 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.- 2p.m.
Wear long-sleeved shirts, pants, hats and sunglasses.
Other Information
- Protect the product in this container from excessive heat and direct sunlight.
- You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222.
Inactive Ingredients
Cyclopentasiloxane, Isododecane, Mica, Polysilicone-11, Polymethylsilsesquioxane, Hexyl Laurate, PEG-10 Dimethicone, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Alumina, Triethoxycaprylylsilane, Dipalmitoyl Hydroxyproline, Diamond Powder, Iron Oxides.
Primary Package (Inner)
61354-051-22_aw (Art Pp05761)
Secondary Package (Outer)
61354-051-22_aw (Art Sp12559 Page 1)
* Please review the disclaimer below.
