Otc - Active Ingredient
Active ingredients purpose
Octinoxate 7.5% Sunscreen
Zinc Oxide 10.8 Sunscreen
Spf 50 Daily Uv Defense Broad Spectrum Sunscreen Cream
FDA Label NDC 70484-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vi Medical Products, Inc for the product Spf 50 Daily Uv Defense Broad Spectrum Sunscreen (NDC 70484-008). 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, indications & usage, warnings, 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 ( 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 help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warnings:
For external use only. Avoid contact with eyes. Rinse with water to remove. Do not use on damaged or broken skin.
Dosage & Administration
Directions: Apply liberally and evenly 15 minutes before sun exposure. Reapply as needed or after towel drying, swimming, or sweating.
Sun Protection Measures: Spending time in the sun increases 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 10am-2pm. Wear long-sleeved shirts, pants, hats and sunglasses
Reapply at least 2 hours. Use a water resistant sunscreen if swimming or sweating.
Children under 6 months, ask a doctor.
Inactive Ingredient
Inactive ingredients: Water, Polysorbate 60, Coconut Alkanes, C12-15 Alkyl Benzoate, Octyldodecanol Neopentanoate, Glycerin, Cetearyl Alcohol, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Benzyl Alcohol, Dimeticone, Xanthan Gum, Phenoxyethanol, Ethylhexylgycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Limon (Lemon) Fruit Extract, Pueraria Lobata Root Extract
Package Label.Principal Display Panel
Vitality Institute
SPF 50 Daily UV Defense Broad Spectrum Sunscreen
2 Fl Oz / 59 mL
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