Label: MELAN SPF-30 BROAD SPECTRUM- avobenzone, homosalate, octisalate lotion
- NDC Code(s): 84294-484-00
- Packager: MELAN INC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 2, 2024
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- Drug Facts
- Active Ingredients
- Uses
- Warnings
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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
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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.
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INGREDIENTS AND APPEARANCE
MELAN SPF-30 BROAD SPECTRUM
avobenzone, homosalate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84294-484 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:84294-484-00 100.55 mL in 1 TUBE; Type 0: Not a Combination Product 05/06/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/06/2024 Labeler - MELAN INC. (088862166)