Broad Spectrum Spf 15 Sunscreen Spray
FDA Label NDC 83810-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Florida Squeezed for the product Broad Spectrum Spf 15 Sunscreen (NDC 83810-010). 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 avobenzone 3.0%, homosalate 15.0%, octisalate 5.0%, octocrylene 8.0%.............sunscreen, uses, warnings for external use only., keep out of reach of children., directions, other information ·, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
· helps prevent sunburn
Warnings For External Use Only.
Flammable:Do not use near heat, flame or while smoking.
Do not useon damaged or broken skin.
When using this product· keep out of eyes . Rinse with water to
remove. · Do not puncture or incinerate. Contents under pressure. Do
not store at temperatures above 1200F.
Stop use and ask doctor ifrash occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Shake well before usng · spray liberally and spread evenly by hand 15 minutes before sun exposure · reapply: · after 80
minutes of swimming or sweating · immediately after towel drying · at least every 2 hours · hold container 4 tob 6 inches from the skin to
apply · do not spray directly into face. Spray on hands then apply to face · do not apply in windy conditions · use in a well-ventilated area.
·
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 sun protection measures including · limit time in the sun, especially
from 10 a.m. - 2 p.m. · wear a long-sleeved shirts, pants, hats, and sunglasses. · children under 6 months: Ask a doctor.
Other Information ·
protect this product from excessive heat and direct sun · may stain fabrics.
Inactive Ingredients
6-O-palmitoylascorbic acid,
Acrylates/Octylacrylamide Copolymer, Alcohol Barbadensis Leaf
Extract, Caprylic/Capric Triglyceride, Citric Acid, Ethanol, Fragrance,
Glycerin, Orange Oil, Tocopherol Acetate
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