MELAN SPF-30 BROAD SPECTRUM- avobenzone, homosalate, octisalate lotion 
MELAN INC.

----------

MELAN SPF-30 Broad Spectrum Lotion

Drug Facts

Active Ingredients

Avobenzone 3.00%

Homosalate 8.00%

Octisalate 5.00%

Purpose

Sunscreen

Uses

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

Other Information

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

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)

Revised: 5/2024
Document Id: 177573a4-c184-2b48-e063-6394a90a9a55
Set id: 75fcef12-bc33-44a7-acda-77d5d7bca2bc
Version: 1
Effective Time: 20240502
 
MELAN INC.