Kinesys Spray
FDA Label NDC 61481-3006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wilc Healthcare Inc for the product Kinesys (NDC 61481-3006). 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, 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 2.5% w/w
Octinoxate 7.5% w/w
Octisalate 5.0% w/w
Octocrylene 7.5% w/w

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

Do Not Use

  • on damaged or broken skin

    • near flame or while smoking

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

Directions

  • Hold container 4 to 6 inches from the skin to apply
  • Spray generously and spread evenly by hand 15 minutes before sun exposure

    • Reapply:

    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Do not spray directly onto the face. Spray into hands, and apply to the face.
    • Do not apply in windy condition
    • Use in 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 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-sleeve shirts, pants, hats, and sunglasses

        • children under 6 months: Ask a doctor

Inactive Ingredients

Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsioxy Phenyl Trimethicone, Fragrance, Octyl Palmitate, Tocopherols, VP/ Hexadecene Copolymer.

Other Information

  • protect the product in this container from extreme temperatures. May stain or damage some fabrics and surfaces.

Questions Or Comments?

Call toll free 1.888.KINeSYS [546.3797] www.kinesysactive.com

Principal Display Panel - 30 Ml Bottle Label

NDC 61481-3006-1

BROAD SPECTRUM SPF 30 UVA+ UVB

OIL FREE CLEAR SPRAY FOR ACTIVE SKIN

KINeSYS®

Performance SUNSCREEN

BROAD SPECTRUM SPF 30 VANILLA-GREEN TEA

80 MINS WATER AND SWEAT RESISTANT

1.0 FL OZ (30 mL)

Image Description (1)

Image Description (1)

NDC 61481-3006-4

BROAD SPECTRUM SPF 30 UVA+ UVB

OIL FREE CLEAR SPRAY FOR ACTIVE SKIN

KINeSYS®

Performance SUNSCREEN

BROAD SPECTRUM SPF 30 VANILLA-GREEN TEA

80 MINS WATER AND SWEAT RESISTANT

4.0 FL OZ (120 mL)

Image Description (4)

Image Description (4)

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