Otc - Active Ingredient
Homosalate 13%
Octisalate 5%
Oxybenzone 4%
Avobenzone 3%
Octocrylene 7%
Degil Sun Spf 50 Sunscreen Lotion
FDA Label NDC 58331-075
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Degil Safety Products (1989) Inc for the product Degil Sun Spf 50 Sunscreen (NDC 58331-075). 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, indications & usage, warnings, otc - keep out of reach of children, instructions for use, inactive ingredient, user safety warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Sun Protection Factor 50 • SPF 50 • Helps prevent sunburn • Sunburn protectant
• Helps protect from sunburn • If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun • Water Resistant (80 minutes)
Warnings
For external use only
Do not use on broken skin
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water
Stop use and ask a doctor if rash occurs
If swallowed, call a poison control centre or get medical help right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Instructions For Use
Adults and children over 6 months of age • Apply liberally/generously (and evenly) 15 minutes before sun exposure • Reapply at least every 2 hours • 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 11 a.m. – 3 p.m.; and ▪ wear long-sleeved shirts, pants, hats and sunglasses • Reapply after 80 minutes of swimming or sweating • Reapply immediately after towel drying
Inactive Ingredient
Aqua, Sorbitol, Aluminium Starch Octenylsuccinate , VP / Eicosene Copolymer, Stearic acid, Triethanolamine, Sorbitan Isostearate, Benzyl Alcohol, Dimethicone, Palmitic acid, Polyglyceryl-3 Distearate, Carbomer, Methylparaben, Propylparaben, Vitamin E, Disodium EDTA
User Safety Warnings
Other information
Protect the product from excessive heat and direct sun
Questions? 1-800-332-1810 / [email protected]
Package Label.Principal Display Panel
DEGIL Sun 50 SPF FPS
SUNSCREEN
Broad Spectrum
UVA & UBV Protection
Protection UVA & UVB
Dermatologist Tested. Moisturizing Aloe &
Vitamin E. Unscented Lotion.
Water Resistant (80 minutes).
DIN 02543443
120 mL(4 fl.oz.)/750 mL(25 fl.oz.)
Distributed by
Degil Safety Products (1989) Inc.
Vaughan,ontario,Canada L4H 0L6
MADE IN CANADA
Dosage & Administration
Lotion
Topical
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