Otc - Active Ingredient
AVOBENZONE 3.0%
OCTISALATE 5.0%
OCTOCRYLENE 4.7%
Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum Spf 50 Ointment
FDA Label NDC 84803-113
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 Hydrating Lip Balm Last Bite Broad Spectrum Spf 50 (NDC 84803-113). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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
Otc - Purpose
SUNSCREEN
Indications & Usage
HELPS PREVENT SUNBURN
if used as directed with other protection measures (see directions) decrease the risk of skin cancer and early skin aging caused by the sun
Warnings
.
Otc - Do Not Use
for external use only
on damaged or broken skin
Otc - When Using
keep out of eyes. rinse with water to remove
Otc - Stop Use
rash occurs
Otc - Keep Out Of Reach Of Children
if swallowed, get medical help or contact a Poisom Control Center right away.
Directions
Directions for Sunscreen Use
apply liberally and evenly 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 10 a.m. – 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
children under 6 months of age: Ask a doctor
Other Information
other information protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Lanolin, Theobroma Cacao (Cocoa) Seed Butter, Cera Alba, Ricinus Communis (Castor) Seed Oil, Butyrospermum Parkii (Shea) Butter, Flavour, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Capyrylic/ Capric Triglyceride, Tocopherol, Myrothamnus Flabellifolia Leaf/Stem Extract, BHT, Limonene, Linalool,Red 28 Lake (CI 45410), Red 33 Lake (CI 17200), Iron Oxides (CI 77499),Titanium Dioxide (CI77891)
Principal Display Panel
Last Bite (2602 Uv Sheen Screen Us 15g Last Bite Cartons Fa2 Ol)
Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50
15g 0.5oz
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