MELAN SPF-30 ANTIOXIDANT BODY MIST SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene liquid

MELAN SPF-30 Antioxidant Body Mist Sunscreen by

Drug Labeling and Warnings

MELAN SPF-30 Antioxidant Body Mist Sunscreen 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 7.50%

Octisalate 5.00%

Octocrylene 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 Extract, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Cananga Odorata (Ylang Ylang) Oil, Caprylic/Capric Triglyceride, Citrus Grandis (Grapefruit) Seed Oil, Citrus Aurantifolia (Lime) Oil, Citrullus Lanatus (Watermelon) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limon (Lemon) Oil, Helianthus Annuus (Sunflower) Oil, Isodecyl Neopentanoate, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Mentha Spicata (Spearmint) Oil, Polysorbate-20, SD-Alcohol 40B, Tetrahexyldecyl Ascorbate (Vitamin C), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vitis Vinifera (Grape) Seed Oil.

Questions?

1-888-676-3890

Package Labeling:

INGREDIENTS AND APPEARANCE

MELAN SPF-30 ANTIOXIDANT BODY MIST SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84294-479
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	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRUS MAXIMA SEED OIL (UNII: Z0829C95PX)
LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)
WATERMELON (UNII: 231473QB6R)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
LEMON (UNII: 24RS0A988O)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PEPPERMINT OIL (UNII: AV092KU4JH)
SPEARMINT OIL (UNII: C3M81465G5)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84294-479-00	177 mL in 1 CAN; 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)