Sunscreen Broad Spectrum Spf 50
FDA Label NDC 69718-155

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vitality Institute Medical Products for the product Sunscreen Broad Spectrum Spf 50 (NDC 69718-155). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients             Purpose

Zinc Oxide  10% ............... Sunscreen

Octinoxate 7.5% .............. Sunscreen

Otc - Purpose

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.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.

Indications & Usage

  • Stop use and ask a doctor if rash occurs

Warnings

Warnings

  • For external use only
  • When using this product keep out of eyes. Rinse with water to remove

Dosage & Administration


Directions

  • Apply evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours or after towel drying, swimming or sweating
  • Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including

  • Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10am-2pm

  • wear long-sleeved shirts, pants, hats, and sunglasses

  • children under 6 months of age: Askj a doctor

Inactive Ingredient

Inactive Ingredients

Water, C12-15, Alkyl Benzoate, Octyldodecly Neopentanoate, Polysorbate 60, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG - 100 Stearate, Coconut Alkanes, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Dimethicone, Aloe Barbadensis Leaf Extract, Citrus Grandis Fruit Extract, Anthemis Nobilis Flower Extract, Pueraria Lobata Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Benzyl Alcohol, Ehtylhexylglycerin, Phenoxyethanol

Package Label.Principal Display Panel

Vitaliy Institute Skin Care System

SPF 50+

Sunscreen Broad Spectrum

2 FL OZ/306mL

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