Label: MELAN SPF-30 BROAD SPECTRUM- avobenzone, homosalate, octisalate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 2, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active Ingredients

    Avobenzone 3.00%

    Homosalate 8.00%

    Octisalate 5.00%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of swimming or sweating
    • 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.
  • Inactive Ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua (Deionized Water), Behenyl Alcohol Butyloctyl Salicylate, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Citrullus Lanatus (Watermelon) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Grandis (Grapefruit) Oil, Cocos Nucifera (Coconut) Oil, Diisopropyl Adipate, Dodecane, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, 1-2 Hexanediol, Lauryl Lactate, Mentha Piperita (Peppermint) Oil, Ocimum Basilicum (Basil) Extract, Oryza Sativa (Rice) Bran Oil, dl-Panthenol, Pentylene Glycol, Phenoxyethanol, Polycrylene, Polysorbate-20, Potassium Cetyl Phosphate, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hydroxide, Sorbitan Olivate, Tocopherol (Vitamin E), Xanthan Gum.

  • Questions?

    1-888-676-3890

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MELAN SPF-30 BROAD SPECTRUM 
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84294-484
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    WATER (UNII: 059QF0KO0R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATERMELON (UNII: 231473QB6R)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DODECANE (UNII: 11A386X1QH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    BASIL (UNII: 2U0KZP0FDW)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ROSEMARY (UNII: IJ67X351P9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84294-484-00100.55 mL in 1 TUBE; Type 0: Not a Combination Product05/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/06/2024
    Labeler - MELAN INC. (088862166)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!