Avobenzone, Homosalate, Octisalate Spray
FDA Label NDC 83324-157

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Avobenzone, Homosalate, Octisalate (NDC 83324-157). 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 15%

Octisalate 5%

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 approaching a source 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°F.

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
  • 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 this container from excessive heat and direct sun

Inactive Ingredients

alcohol denat., diisopropyl adipate, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, neopentyl glycol diheptanoate, acrylates/octylacrylamide copolymer, fragrance, benzyl benzoate, butylphenyl methylpropional, citronellol, tocopheryl acetate

Adverse Reaction

May stain or damage some fabrics or surfaces

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Principal Display Panel

NDC 83324-157-55

QC ®

QUALITY CHOICE

Sheer Touch

Sunscreen 

Mist

Broad Spectrum

SPF 100

UVA/UVB Sunscreen

Water Resistant (80 Minutes)

Dermatologist Tested

Clean & Lightweight Feel

SPF 100

NET WT 5.5 oz (156g)

Image Description (Mm01)

Image Description (Mm01)

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