Self Reflect Probiotic Sunscreen Moisturizer Broad Spectrum Spf 32
FDA Label NDC 62742-4181

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs Inc for the product Self Reflect Probiotic Sunscreen Moisturizer Broad Spectrum Spf 32 (NDC 62742-4181). 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, indications & usage, warnings and precautions, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients:

Zinc Oxide 22.4%

Otc - Purpose

Purpose: Sunscreen

Indications & Usage

Uses:

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and  early skin aging caused by the sun.

Warnings And Precautions

Warning: For external use only.

Otc - Do Not Use

Do not use: on damaged or broken skin.

Otc - When Using

When using this products:

  • Keep out of eyes.
  • Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor: If rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children:

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

Dosage & Administration

Directions:

  • Apply generously 15 minutes before sun exposer.
  • Use a water resistant sunscreen if swimming or sweating. 
  • Reapply 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 10am - 2pm.
  • Wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.

Other Safety Information

Other Information: Protect the product from excessive heat and direct sun.

Inactive Ingredient

Inactive Ingredients: Water (Aqua), Caprylyc/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Malus (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus (Red Rasberry) Seed Oil, Cocos Nucifera (Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizate, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Caprylyl/Capryl Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Tapioca Starch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contains +/- Iron Oxides (Cl77491, Cl77492)

Otc - Questions

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Corte Modera, CA 94925

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