Sunscreen Spray
FDA Label NDC 55910-012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Sunscreen (NDC 55910-012). 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, flammable, do not use, when using this product, stop use and ask a doctor, 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 15%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Flammable

Keep away from fire or flame.

  • after application, wait until product dries before approaching a souce of heat or flame, or before smoking

Do Not Use

On damaged or broken skin

When Using This Product

  • Keep out of eyes.  Rinse with water to remove.
  • contents under pressure.  Do not puncture or incinerate. Do not store at temperature above 120

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

  • spray liberally and spread evenly by hand 15 minutes before sun exposure.
  • apply to all skin exposed to the sun
  • do not spray directly into face.  Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in a well-ventilated area and avoid inhalation
  • reapply after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun protction 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 incluing:
  • limit the time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • cildren under 6 month of age: Ask a doctor

Other Information

  • protect the product in the container from excessive heat and direct sun

Inactive Ingredients

alcohol denat., acrylates/octylacrylamide copolymer, glycerin, butyloctyl salicylate, triethanolamine, fragrance

Claims

May stain or damage some fabrics or surfaces 

Oxybenzone &  Octinoxate free

Disclaimer

This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Spray Sport Broad Spectrum SPF 70

DSP-TN-15000  DSP-MO-34 SDS-TN-15012

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STUDIO

SELECTION

SUN

SUNSCREEN

SPRAY

BROAD SPECTRUM SPF 70

Compare to Coppertone Sport Broad Spectrum SPF 70

  • Water-resistant (80 minutes
  • Continuous spray from any angle

    • SPF 70

    Family

    Size

    Dermatologist-Tested

    Hypoallergenic

    NET WT 9.1 OZ (258 g)

    Image Description (Mm4)

    Image Description (Mm4)

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