Sunscreen
FDA Label NDC 55910-874

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 55910-874). 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, 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, Homosalate, Octisalate, Octocrylene

Purpose

sunscreen

Uses

■ helps prevent sunburn

■ if used as directed with other sun 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 approacing a souce of heat or flame, or before smoking

Do Not Use

  • on damaged or broken skin

Stop Use And Ask A Doctor If

  • rash occurs

Keep Out Of Reach Of Children

if swallowed, get medical help or contact a Poison Conrol Center right away

Direction

■ spray liberally and spread evenly by hand 15 minutes before sun exposure
■ apply to all skin exposed to the sun
■ hold container 4 to 6 inches from the skin to apply
■ 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 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, especially 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 in the container from excessive heat and direct sun

Inactive Ingredients

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

Adverse Reactions

May stain or damage some fabrics of surfaces

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Principal Display Panel

STUDIO

SELECTION

SUN

SUNSCREEN 

SPRAY FOR

KIDS

BROAD SPECTRUM SPF 50

  • Water-Resistant(80 minutes)
  • UVA/UVB protection

    • SPF 

    50

    Octinoxate,

    Oxybenzone

    & Paraben Free

    NET WT 5.5 OZ (156 g)

    Image Description (Mm3)

    Image Description (Mm3)

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