Active Ingredients
AVOBENZONE 3.0%
OCTINOXATE 5%
OCTOCRYLENE 4.7%
Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum Spf 50 Ointment
FDA Label NDC 84803-114
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 Silk Pillow Broad Spectrum Spf 50 (NDC 84803-114). 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, use, warnings, for external use only, do not use, when using ths product, stop use and ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
SUNSCREEN
Use
HELPS PREVENT SUNBURN
IF USE A 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 Ths Product
KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
Stop Use And Ask Doctor
RASH OCCURS
Keep Out Of Reach Of Children
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON 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
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, Titanium Dioxide (Cl 77891), Red 33 Lake (Cl 17200), Red 30 Lake (Cl 73360).
Other Information
other informatom protect the rproduct in this container from excessive heat and direct sun.
Package Label.Principal Display Panel
Silk Pillow (2601 Uv Sheen Screen Us 15g Silk Pillow Cartons Fa1 Ol)
Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50
15g 0.5oz
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