Sunscreen Spf 30
FDA Label NDC 41520-347

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Careone for the product Sunscreen Spf 30 (NDC 41520-347). 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 actives, ​​​purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Actives

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 10.0%

​​​Purpose

Sunscreen

Uses

  •  helps prevent sunburn • Higher SPF gives more sunburn protection•retains SPF after 80 minutes of activity in the weater or sweating • provides hight protection against sunburn

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 or irritation develops and lasts

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: • After 80 minutes of swimming or sweating • Immediately after towel drying • 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 of 15 or higher and other sun protection measure 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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl Syringylidemaionate, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Oieth-3, Polyamide-8, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water.

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