Dr Loretta Universal Glow Daily Defense Spf 40 Cream
FDA Label NDC 71501-1910

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Loretta, Llc for the product Dr Loretta Universal Glow Daily Defense Spf 40 (NDC 71501-1910). 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

Zinc Oxide 17%

Purpose

Sunscreen

Uses

Helps prevent sunburn

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 occurs.

Keep Out Of Reach Of Children.

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

Directions

  • Apply liberally and evenly 15 minutes before sun exposure. 
  • 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 this risk, regularly use a sunscreen with Broad Spectrum SPF value 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.
  • Children under 6 months of age: Ask a doctor.

Other Information

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

Inactive Ingredients:

Aqua (Water, Eau), Isododecane, Propanediol, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, C12-15 Alkyl Benzoate, Dimethicone, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Coco-Caprylate/Caprate, Ethylhexyl Palmitate, Polymethylsilsesquioxane, Disteardimonium Hectorite, Polyglyceryl-10 Dioleate, Propylene Carbonate, Polyhydroxystearic Acid, Lecithin, Phenoxyethanol, Tapioca Starch Polymethylsilsesquioxane, Polysilicone-11, Butyrospermum Parkii (Shea) Butter, Ectoin, Glycerin, Polyglyceryl-10 Laurate,Tromethamine, Ethylhexylglycerin, Octyldodecanol, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Rose Geranium) Flower Oil, Decyl Glucoside, Dimethylmethoxy Chromanol, Sodium Benzoate, Betula Alba (Birch) Bark Extract, Boswellia Serrata (Indian Frankincense) Extract, Polygonum Cuspidatum Root Extract, Caprylyl Glycol, Hexylene Glycol, Jojoba Esters, Trihydroxystearin, Alumina, Centella Asiatica (Gotu Kola) Extract, Tocopherol, Silica, Titanium Dioxide (CI 77891), Iron Oxide (CI 77492, CI 77491), Citronellol, Geraniol, Limonene, Linalool.

Package Labeling:1.5 Ml

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Label0 (Label0)

Package Labeling:100 Ml

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