5283 Sunscreen Lotion
FDA Label NDC 76138-222
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Innovation Specialties for the product 5283 Sunscreen (NDC 76138-222). 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 drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Avobenzone 3%
Homosalate 10%
Octocrylene 10%
Octisalate 5%
Purpose
Sunscreen
Uses
• helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Apply liberally 15 minutes exposure. • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.
Sun Protection Measure. 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 higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeve shirts, pants, hats and sunglasses • children under 6 months: Ask a doctor.
Inactive Ingredients
Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolyrner, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA
Other Information
• Protect this product from excessive heat and direct sun
Questions Or Comments?
Call:1-855-755-5346
Packaging
5283sunscreen (7613822201)
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