MESOESTETIC MESOPROTECH MELAN 130 PIGMENT CONTROL- avobenzone, homosalate, octocrylene emulsion

Mesoestetic Mesoprotech Melan 130 Pigment Control by

Drug Labeling and Warnings

Mesoestetic Mesoprotech Melan 130 Pigment Control by is a Otc medication manufactured, distributed, or labeled by MESOESTETIC PHARMA GROUP SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Package Labeling:

INGREDIENTS AND APPEARANCE

MESOESTETIC MESOPROTECH MELAN 130 PIGMENT CONTROL 
avobenzone, homosalate, octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76450-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	85 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BEMOTRIZINOL (UNII: PWZ1720CBH)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISOCTRIZOLE (UNII: 8NT850T0YS)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
POLYSILICONE-15 (UNII: F8DRP5BB29)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)
POLYAMIDE-5 (UNII: UEM62QMW5F)
POTASSIUM AZELOYL DIGLYCINATE (UNII: N02RVN6NYP)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76450-001-01	1 in 1 BOX	05/01/2025
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2025

Labeler - MESOESTETIC PHARMA GROUP SL (461675592)

Establishment
Name	Address	ID/FEI	Business Operations
MESOESTETIC PHARMA GROUP SL		461675592	manufacture(76450-001)