Sunfree Sunscreen
FDA Label NDC 51532-6103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Afassco for the product Sunfree Sunscreen (NDC 51532-6103). 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 other, active ingredients, purpose, uses, warnings, when using this product, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Homosalate (6.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (5.0%)

Purpose

Sunscreens

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn

Warnings

Spending Time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.

When Using This Product

  • keep out of eyes
  • Rinse with water to remove

Otc - Keep Out Of Reach Of Children

Keep out of reach of children If swallowed, get medical help or contact a poison control center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
  • protect from excessive heat and direct sun

Inactive Ingredients

cetyl alcohol, ganex P-904, germaben II, petrolatum, polyoxyl 40 stearate, polysorbate 60, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

Principal Display Panel - Packet Label

SUNFREE™
SUNSCREEN

SPF 30 PABA Free

Net contents 3.5g (1/8 oz.)

Mfd for:

Afassco::®

Minden, NV 89423

800-441-6774

Principal Display Panel (Packet Label)

Principal Display Panel (Packet Label)

* Please review the disclaimer below.