Otc - Active Ingredient
Active ingredients
Purpose
Titanium dioxide 4%,Zinc oxide 7% ................Sunscreen
Bellas Friends Roll-on Sunscreen Lotion
FDA Label NDC 85950-004
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 Roll-on Sunscreen (NDC 85950-004). 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, dosage & administration, indications & usage, 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
USe.helps prevent sunburn .if used as directed with othersun protection measures(see Directions decreases 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 immediately.
Warnings
Warnings For external use only
Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with waterto remove.
Stop use and ask a doctor if rash occurs
Dosage & Administration
shake well before use .apply liberally and spread by hand 15 minutes before sun exposure .reapply:.after 80 minutes of swimming or sweating.immediatelyafter towel drying.at least every 2 hours
Indications & Usage
children under6 months of age:ask a doctor .Sun Protection Mleasures.Spending time in the sun increases your risk of skin cancerand early skin aging. To decrease this risk, reqularly usea sunscreen with a Broad Spectrum SPF value of 15 orhigher and other sun protection measures including:limittime in the sun, especially from 10 a.m.-2 p.m. .wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredient
Inactive ingredientswater,caprylic/capric triglyceride,dimethicone,tocopherol,glycerin, hydrogenated polyisobutene, butylene glycol dicaprylate/dicaprate,silica / silicon dioxide,vinyldimethicone/methicone silsesquioxane crosspolymer,triethoxycaprylylsilane,Osmanthus fragrans flower extract,trimethylsiloxysilicate, disteardimonium hectorite,butyleneglycol, Portulaca oleracea extract, Chrysanthellum indicum,Aloe barbadensis extract, Sophora angustifolia root extract.
Package Label.Principal Display Panel
Labeling (85950 004 01)
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