Visor Clear Body Oil-free Sunscreen Spf 50 Gel
FDA Label NDC 85335-589

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Visor Skincare Llc for the product Visor Clear Body Oil-free Sunscreen Spf 50 (NDC 85335-589). 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 ingredient, purpose, uses., warnings, do not use, when using this product, stop use and ask a 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 Ingredient

Avobenzone, 3.00%
Homosalate 10.00%
Octisalate 5.00%
Octocrylene 10.00%

Purpose

Sunscreen

Uses.

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of swimming or sweating
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agingcaused by the sun.

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.

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 increase 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.-2p.m.
  • Wear long-sleeved shirts, pants,hats,and sunglasses.

Other Information

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Ascorbic Acid, Beeswax, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Isododecane, Jojoba Esters, Lecithin, Meadowfoam Estolide, Microcrystalline Wax (Cera Microcrystalline), Polyhydroxystearic Acid, Silica, Sodium Hyaluronate, Tocopherol, Tridecyl Salicylate, Zinc Sulfate.

Questions?

Call 203-293-3057

Package Labeling:

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