Tinted Radiance Moisturizer Broad Spectrum Spf 32 Medium To Tan
FDA Label NDC 62742-4084

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 Tinted Radiance Moisturizer Broad Spectrum Spf 32 Medium To Tan (NDC 62742-4084). 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.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:

Zinc Oxide - 6.0%

Titanium Dioxide - 4.5%

Otc - Purpose

Purpose:

Sunscreen

Indications & Usage

Uses:

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures, 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 swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

For Sunscreen use:

  • Apply liberally 15 minutes before sun exposer.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: ask a doctor.
  • Sun protection measures.Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease the 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 10 a.m. - 2 p.m.
  • wear long sleeve shirts, pants, hats and sunglasses.

Inactive Ingredient

Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone Ployglyceryl-3, Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG -10/15 Crosspolymer, Stearic Acid, Aluminum Hydroxide, Sodium Chloride, Glycerin, Magnolia officinallis Bark Extract, Ectoin, Caprylyl Glycol, Teprenone, Sodium Hyaluronate, Vitis Vinifera, (Grape) seed extract, Tetrahexyldecyl Ascorbate, Ergothioneine, Tocopheryl Acetate, Tocopherol, Maltodextrin, Lecithin, Ethylhexyl Palmitate Caprylyc/Capric Triglyceride, PEG/PPG-18/18 Dimethicone, Polyglycerin-3 Crosspolymer, Hexyl Laurate, Cyclohexasiloxane, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Dimethicone/Venyl Dimethicone Crosspolymer, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Silica Dimethyl Sylilate, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Butylene Glycol, Hexylene Glycol Fragrance, Mica, Silaca, May contains: Iron Oxide.

Package Label.Principal Display Panel

Dist. By.

EVER LLC

Sausalito, CA 94965

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