Otc - Active Ingredient
Active Ingredient
Zinc Oxide25%...
Purpose
..Sunscreen
Bellas Friends Sunscreen Stick Paste
FDA Label NDC 85950-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Panergytek Usa Inc for the product Bellas Friends Sunscreen Stick (NDC 85950-003). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Helps prevent sunburn.
If used as directed with other sun protection measures(See Directions), decresses the risk of skin cancer
and early skin aging caused by the sun.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children,if a product is swallowed, get medical help or contact a Poison Control
center right away.
Warnings
Warnings
For external use only.
Do not use on damaged or broken skin.
When using this product keep out of eye. Rinse with water to remove.
Stop use and ask doctor if rash occurs.
Indications & Usage
Apply liberally to exposed areas 15 minutes before sun exposure.
Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-
drying.
Dosage & Administration
Sun protection MeasuresSpending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk,'egularly use a sunscreen with a broad spectrum SPF of 15 or higher and other protection measuresincluding: .Limit time in the sun, especially from 10 a.m. - 2 p.m..Wear long-sleeve shirts, pants, hatand sunglasses. Children under 6 months: ask a doctor
Inactive Ingredient
Inactive Ingredients:
BEESWAX, TOCOPHEROL(Vitamin E), CHAMOMILE FLOWER OIL, ETHYLHEXYL PALMITATE, DIBUTYLETHYLHEXANOYL GLUTAMIDE, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, BISABOLOL
Package Label.Principal Display Panel
Labeling (85950 003 01)
* Please review the disclaimer below.
