Uses
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.
Utu Hydrating Sun Balm Broad Spectrum Spf 50 Ointment
FDA Label NDC 87952-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Utu Co for the product Utu Hydrating Sun Balm Broad Spectrum Spf 50 (NDC 87952-003). 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 uses, directions, warnings, keep out of reach of children, inactive ingredients, other information, purpose, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Directions
• Apply liberally and evenly 15 minutes before sun exposure
• Reapply after 80 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours
• Sun Protection measures. Spending time in the sun increases your 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 10am-2pm.
• Wear long-sleeve shirts, pants, hats and sunglasses.
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 swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Prunus Amygdalus Dulcis (Sweet Almond Oil), Vegetable Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Simmondsia Chinese (Jojoba) Seed Extract, Euphorbia Cerifera (Candelilla) Wax, Polyglyceryl-4 Olivate/Polyricinoleate, Elaeis Guineensis (Palm) Butter, Glyceryl Caprylate, Tapioca Starch, Polymethylsilsesquioxane, Tocopheryl Linoleate/Oleate, Cetearyl Alcohol, Water, Glyceryl Undecylenate, Hippophae Rhamnoides Fruit Oil, Tremella Fuciformis Sporocarp (Silver Ear Mushroom) Extract, Curcuma Longa (Turmeric) Root Extract, Ceramide NP, Bisabolol, Haematococcus Pluvialis Algae Extract.
Other Information
Protect this product from excessive heat and direct sun.
Purpose
Sunscreen
Principal Display Panel
Hydrating Sun Balm. SPF 50. Broad Spectrum.
Face & Lip Protector.
Mineral Zinc Oxide, ceramide NP, snow mushroom, sea buckthorn, jojoba oil, vitamin E, astaxanthin.
* Please review the disclaimer below.
