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

MELAN SPF-30 Broad Spectrum by

Drug Labeling and Warnings

MELAN SPF-30 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by MELAN INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Product 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)