Guidance To Glow Tru Spf 35 Cream
FDA Label NDC 84444-506

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guidance To Glow Skin Care for the product Guidance To Glow Tru Spf 35 (NDC 84444-506). 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 ingredients, purpose, uses:, warnings:, do not use, when using this product:, stop use and ask a doctor:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Zinc Oxide 12%

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 ok skin cancer and early skin aging caused by the sun

Warnings:

For external use ONLY

Do Not Use

on damaged skin

When Using This Product:

keep out of eyes Rinse with water to remove

Stop Use And Ask A Doctor:

Rash or irritation develops and lasts

Keep Out Of Reach Of Children.

If swallowed,get medical help or contact a poison control center right way.

If Pregnant Or Breastfeeding,

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
  • Sun Protection Measures.

    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. Regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including

    • Limit time in the sun especially from 10a.m - 2 p.m
    • Wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

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

Water Resistant 80 minutes.

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Caprylic/Capris Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Oat Protein, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Malus Domestica (Apple) Extract Phenoxyethanol, Plankton Extract, Polyacrylamide, Polyhydroxystearic Acid, Polysorbate-20, Potassium Sorbate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Squalane, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum, Zemea (Corn) Propanediol

Any Questions?

818-863-6299

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