Naturalessa Spf50 Moisturizer Cream
FDA Label NDC 83695-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Audrey Morris Cosmetics International, Llc for the product Naturalessa Spf50 Moisturizer (NDC 83695-003). 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 ingredients                          purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients                          Purpose

Zinc Oxide 22.3% W/W                    Sunscreen

Uses

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

Warnings

For Extranal 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 doctor

    • Rash or irritation develops and lasts

      • Keep out of reach if children

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

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying.
  • At least every 2 hours
  • 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 of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10:00a.m – 2:00p.m
  • Wear long sleave shirts, pants, hats, and sunglasses.
  • Children under 6 Months: Ask a doctor

Other Information

Protect this product from excessive heat and direact sun

Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Coco-Caprylate/Caprate, Butyl Salicylate, Isoamyl Laurate, Glycerin, Shea (Butyrospermum Parkii) Butter, Jojoba (Simmondsia Chinensis) Seed Oil, Propanediol, Tridecyl Salicylate, Polyglyceryl-6 Stearate, Polyglyceryl-6 Behenate, Green Tea (Camellia Sinensis) Leaf Extract, Sphingomonas Ferment Extract, Pongamia Pinnata Seed Extract, Xanthan Gum, Cetyl Alcohol, Silica, Lecithin, Sclerotium Gum, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Pullulan, Phenoxyethanol, Ethylhexylglycerin, Fragrance.

Questions Or Comments?

1-800-826-8287

Product Label

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