Fitglow Vita Shield Hyaluronic Primer Spf-30 Cream
FDA Label NDC 72975-277

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fitglow Beauty Llc for the product Fitglow Vita Shield Hyaluronic Primer Spf-30 (NDC 72975-277). 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 ingredient(s), purpose, use(s), 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 Ingredient(S)

Zinc Oxide 14%

Purpose

Sunscreen

Use(S)

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • 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.

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 at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats and sunglasses.

Other Information:

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

Inactive Ingredients

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Astaxanthin, Benzyl Alcohol, Betula Alba (Birch) Extract, Butyrospermum Parkii (Shea) Butter,C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dehydroacetic Acid, Dodecane, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Lecithin, Mangifera Indica (Mango) Butter, Prunus Domestica (Plum) Fruit Extract, Punica Granatum (Pomegranate) Extract, Rubus Chamaemorus (Cloudberry) Oil, Sodium Polyacrylate, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate, Propanediol.

*Indicates certified organic ingredient.

Questions?

Distributed by Fitglow Beauty LLC, 700 NE 13 Street, Ft. Lauderdale Florida, 33304 www.fitglowbeauty.com

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