Active Ingredients
Avobenzone 3%
Octinoxate 5%
Octocrylene 4.7%
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled Ointment
FDA Label NDC 84803-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grace And Fire Usa Inc. for the product Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled (NDC 84803-105). 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, stop use and ask doctor if, otc - keep out of reach of children, directions, inactive ingredients, 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
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 Doctor If
- rash occur
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
if swallowed , call a poison control centre or get medical help right away
Directions
* Apply liberally 15 minutes before sun exposure
* Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating
* 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 10a.m.- 2p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor
Inactive Ingredients
Lanolin, Theobroma Cacao (Cocoa) Seed Butter, Cera Alba, Ricinus Communis (Castor) Seed Oil, Butyrospermum Parkii (Shea)
Butter, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Flavour, Caprylic/Capric Triglyceride, Tocopherol, Myrothamnus Flabellifolia Leaf/Stem Extract, Titanium Dioxide ,Mica, (Cl 15850:1), Iron Oxide Red (CI 77491).
Other Information
Protect this product from excessive heat and direct sun
* Please review the disclaimer below.
