Mesoestetic Mesoprotech Melan 130 Pigment Control Emulsion
FDA Label NDC 76450-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mesoestetic Pharma Group Sl for the product Mesoestetic Mesoprotech Melan 130 Pigment Control (NDC 76450-001). 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.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 3%

Homosalate 8%

Octocrylene 8.5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn.
  • 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 occurs 

Keep Out Of Reach Of Children.

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

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply: 
  • after 40 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 a Broad Spectrum SPF value 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
  • children under 6 months of age: Ask a doctor 

Other Information

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

Inactive Ingredients:

Water, dibutyl adipate, cyclopentasiloxane, bis-ethylhexyloxyphenol methoxyphenyl triazine, alcohol denat., titanium dioxide, methylene bis-benzotriazolyl tetramethylbutylphenol, cyclohexasiloxane, PEG-30 dipolyhydroxystearate, polysilicone-15, styrene/acrylates copolymer, PEG-10 dimethicone, silicon dioxide, bis-ethylhexyl hydroxydimethoxy benzylmalonate, polyamide-5, potassium azeloyl diglycinate, jojoba esters, hexyl laurate, sunflower (Helianthus annuus) seed oil, dimethicone, ethylhexylglycerin, green wattle (Acacia decurrens) flower wax, polyglycerin-3, polyamide-3, cetyl PEG/PPG-10/1 dimethicone, polyglyceryl-4 isostearate, sodium chloride, VP/hexadecane copolymer, decyl glucoside, disteardimonium hectorite, disodium EDTA, PEG-12 alkyl ether, hydrogenated lecithin, propylene glycol, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, fragrance, synthetic iron oxide.

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