Tanceuticals Spf Drops Broad Spectrum Spf-30 Solution
FDA Label NDC 82675-279

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tanceuticals, Llc for the product Tanceuticals Spf Drops Broad Spectrum Spf-30 (NDC 82675-279). 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:, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Avobenzone 3.00%, Homosalate 10.00%,

Octisalate 5.00%, Octocrylene 6.00%

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 or as needed 
  • Reapply:After 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 sking aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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

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

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Chamomilla Matricaria (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extract, Cocamidopropyl Betaine, Daucus Carota Sativa (Carrot) Extract, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydrogenated Methyl Abietate, Isopropyl Myristate, Mangifera Indica (Mango) Butter, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Phenyl Trimethicone, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Sodium Benzoate, Sodium Hyaluronate, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E).

Questions?

Call us at 800-994-3752

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