Allies Of Skin Sunless Tan Spf 50 Daily Self Tanner Liquid
FDA Label NDC 83852-543

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allies Group Pte. Ltd. for the product Allies Of Skin Sunless Tan Spf 50 Daily Self Tanner (NDC 83852-543). 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 if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients

Avobenzone 3.00% 

Homosalate 7.30%

Octocrylene 7.50% 

Octisalate 5.00%

Purpose

Sunscreen

Uses:

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

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 or irritation develops and lasts.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

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
  • 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 the 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 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information:

  • Protect the product in this container from excessive heat and direct sun.
  • May stain or damage some fabrics or surfaces.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, C9-12 Alkane, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Daucus Carota Sativa (Carrot) Seed Extract, Dihydroxyacetone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Dodecane, Ethyl Vanillin, Ethylhexylglycerin, Glycerin, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Isododecane, Lactobacillus Ferment, Lycium Barbarum Fruit Extract, Magnesium Aluminum Silicate, Octyldodecyl Neopentanoate, Phenoxyethanol, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Punica Granatum Fruit Extract, Sodium Hyaluronate, Sodium Metabisulfite, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum

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