Otc - Active Ingredient
Active Ingredient
Zinc Oxide 24%.......
..
PurposeSunscreen
Bella S Friends Spf50 Sunscreen Spray
FDA Label NDC 85950-005
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 Bella S Friends Spf50 Sunscreen (NDC 85950-005). 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
Uses
Helps prevent sunburn.If used as directed with other sun protection measures(SeeDirections), 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 swallowed, get medical help or contact a Poison Control center right away.
Warnings
WarningsFor external use only. FLAMMABLE.Don't use near heat, flame or while smoking.Do not use on damaged or broken skin.When using this product .keep out of eye. Rinse with water to remove. Keep away form face to avoid breathing it. .Use only as directed. .Don't puncture or incinerate. Contents underpressure..Don't store at temperatures above 120F(49C).
Indications & Usage
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 of 15 or higher and other protection measures including:. Limit time in the sun,especially from 10 a.m. - 2 p.m..Wear long-sleeve shirts,pants, hats, and sunglasses.
Dosage & Administration
hake well before use. .Hold container 4 to 6 inches from the skin to apply.-Don't spray directly into face. Spray into hands then apply to face. .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
Inactive Ingredient
Inactive Ingredients: Water (Aqua), Chrysanthellum Indicum Extract, Isobutane,Triethoxycaprylylsilane, Dimethicone, Ethylhexyl Palmitate,Gentiana Scabra Root Extract, Isododecane, Glycerin, C9-12 Alkane, Acrylates Copolymer, Butyloctyl Salicylate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride,Phenoxyethanol, Ethylhexylglycerin, Bisabolol, ButyleneGlycol, Hydroxyacetophenone.
Package Label.Principal Display Panel
Labeling (85950 005 01)
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