Mesoestetic Mesoprotech Melan 130 Pigment Control Sunscreen Spf 50+

Mesoestetic Mesoprotech Melan 130 Pigment Control Sunscreen Spf 50+
SPL v1
SPL
SPL Set ID 3b50e874-9665-4df4-8b3a-fc932c29f3f6
Route
TOPICAL
Published
Effective Date 2025-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (80 mg) Octocrylene (85 mg)
Inactive Ingredients
Water Dibutyl Adipate Cyclomethicone 5 Bemotrizinol Alcohol Titanium Dioxide Bisoctrizole Cyclomethicone 6 Peg-30 Dipolyhydroxystearate (4000 Mw) Polysilicone-15 Silicon Dioxide Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate Polyamide-5 Potassium Azeloyl Diglycinate Hexyl Laurate Sunflower Oil Dimethicone Ethylhexylglycerin Acacia Decurrens Flower Wax Polyglycerin-3 Polyglyceryl-4 Isostearate Sodium Chloride Vinylpyrrolidone/hexadecene Copolymer Decyl Glucoside Disteardimonium Hectorite Edetate Disodium Propylene Glycol Xanthan Gum Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Avobenzone 3% Homosalate 8% Octocrylene 8.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 8% Octocrylene 8.5%

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.

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 
Drug Facts

Do Not Use 
  • on damaged or broken skin.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 8%

Octocrylene 8.5%

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.

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.


Structured Label Content

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.
Purpose

Sunscreen

Warnings

For external use only.

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 
Drug Facts

Do Not Use  (Do not use )
  • on damaged or broken skin.
Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 8%

Octocrylene 8.5%

Inactive Ingredients: (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.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs 
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.


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