Sunsect Insect Repellent Sunscreen
FDA Label NDC 57595-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Iguana Llc for the product Sunsect Insect Repellent Sunscreen (NDC 57595-001). 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 active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, comments/questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Octinoxate: 7.5%
Oxybenzone: 6%
Octisalate: 5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunbrun, not skin cancer or early skin aging.

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. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • children under 6 months of age: Ask a doctor
  • reapply: after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Other Information

  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

acrylates/C10-30 alkyl acrylate copolymer, carrageenan, carboxy vinyl polymer, cetostearyl alcohol, diazolidinyl urea, diethanolamine cetyl phosphate, methylparaben, propylparaben, propylene glycol, tocopheryl acetate (Vitamin E), tricontanyl povidone, water

Comments/Questions?

1-229-228-0980

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