Sunscreen Lotion
FDA Label NDC 41520-769

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Sunscreen (NDC 41520-769). 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, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protections measures (see Directions), decreases the rist of skin cancer and early skin aging caused by the sun

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 occurs

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
  • 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especiallyu from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information

  • Protect the product from excessive heat and direct sun

Inactive Ingredients

water, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, olethe-3, disodium EDTA

Questions Or Comments?

1-800-632-6900

Other

*This product is not manufacured or distribued by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 30.

May stain or damage some fabrics or surfaces.

Distributed by Foodhold USA, LLC

Landover, MD 20785

1-877-849-9949

Quality guaranteed your your money back.

769.000/769AA

Principal Display Panel

Care One

compare to Coppertone Ultra Guard Sunscreen Lotion SPF 30*

Sunscreen Lotion

SPF 30 UVA/UVB protection

BROAD SPECTRUM SPF 30

water resistant (80 minutes)

Enriched with moisturizers

Hypoallergenic

8 FL OZ (236 mL)

Image Description (Mm3)

Image Description (Mm3)

* Please review the disclaimer below.