Ewc Slow Lightweight Sunscreen Spf 50 Spray
FDA Label NDC 81756-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ewc Ventures, Llc for the product Ewc Slow Lightweight Sunscreen Spf 50 (NDC 81756-001). 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 drug facts, active ingredients, purpose, use, warnings, do not use, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 3.00% 
Homosalate 10.00% 
Octisalate 5.00% 

Purpose

Sunscreen

Use

  • helps prevent sunburn.

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.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above
    120F.

Stop Use And Ask Doctor If

  • rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Flammable:Do not use near heat, flame or while smoking.

Directions

  • Shake well before using.
  • Hold container 4 to 6 inches from the skin to apply.
  • apply liberally and spread evenly by hand 15 minutes before sun exposure and as needed.
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.
  • Do not spray directly onto face. Spray into hands and apply to face, avoiding the eye area.
  • Do not apply in windy conditions.
  • Use in a well-ventilated area.
  • 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 this container from excessive heat and direct sun
  •  may stain some fabrics

Inactive Ingredients

alcohol denat., va/butyl maleate/isobornyl acrylate copolymer, amyl cinnamal, benzyl salicylate, butyloctyl salicylate, cananga odorata oil/extract, citronellol, cocos nucifera (coconut) water, geraniol, glycerin, hexyl cinnamal, hydroxycitronellal, leuconostoc/radish root ferment filtrate, narcissus tazetta bulb extract, oryza sativa (rice) bran oil, parfum (fragrance), polyester-8, water

Questions Or Comments?

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Package Labeling

Bottle (Bottle)

Bottle (Bottle)

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