Otc - Active Ingredient
Active Ingredient
Avobenzone - 2.9% - Homosalate - 4.0% - Octisalate - 4.9% - Octocrylene - 9.5%
Sun Protection Spf 50 Spray
FDA Label NDC 83694-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skinresource.md, L.l.c. for the product Sun Protection Spf 50 (NDC 83694-011). 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, inactive ingredient, otc - keep out of reach of children, warnings, otc - purpose, dosage & administration, indications & usage, 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
Inactive Ingredient
Inactive Ingredients:
Acrylates/Octylacrylamide Copolymer, Alcohol Denat, Aloe Barbadensis Leaf Extract, Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Seed Oil, Ethyl Ferulate, Helianthus Annuus (Sunflower)
Seed Oil*, Polyester-8, Tocopherol.
* Indicates Certified Organic Ingredient.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children:
if product is swallowed, get medical help or contact a Poison Control Center right away
Warnings
Warnings (Warnings)
For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames.
Protect this product from excessive heat and direct sun
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 skin irritation or redness occurs for more than 72 hours.
Otc - Purpose
Purpose (Purpose)
Dosage & Administration
Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day or after swimming or sweating. • Children under 6 months: ask a doctor.
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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.
to 2 p.m. • Wear long-sleeved shirts, pants, hats, and sun glasses.
Indications & Usage
Uses • Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
• For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames.
Protect this product from excessive heat and direct sun
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 skin irritation or redness occurs for more than 72 hours.
Keep out of reach of children
If product is swallowed, get medical help or contact a Poison Control Center right away
Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day after swimming or sweating. • Children under 6 months: ask a doctor.
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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.
to 2 p.m. • Wear long-sleeved shirts, pants, hats, and sun glasses.
* Please review the disclaimer below.
