FDA.reportPublic FDA data

MELAN SPF-30 Antioxidant Body Mist Sunscreen

Manufacturer
MELAN INC.
Effective date
2024-05-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:03

Label at a glance#

ProductMELAN SPF-30 Antioxidant Body Mist Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and 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

Dosage and administration

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 ot...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00%

Homosalate 7.50%

Octisalate 5.00%

Octocrylene 5.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • 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:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-888-676-3890

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0Label1Label1Label2Label2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84294-479-00MELAN SPF-30 Antioxidant Body Mist Sunscreen177 mL in 1 CANLIQUID1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84294-479MELAN SPF-30 ANTIOXIDANT BODY MIST SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LIQUID [MELAN INC.]1Current NDC, 1 package rows20240507_66b7c899-46fd-41a6-9a96-ebbf2b68ea25.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84294-47984294-479-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CITRUS MAXIMA SEED OILZ0829C95PXIACT
LIME OIL, COLD PRESSEDUZH29XGA8GIACT
WATERMELON231473QB6RIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
LEMON24RS0A988OIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
LAVENDER OILZBP1YXW0H8IACT
PEPPERMINT OILAV092KU4JHIACT
SPEARMINT OILC3M81465G5IACT
POLYSORBATE 207T1F30V5YHIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
GRAPE SEED OIL930MLC8XGGIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELAN SPF-30 Antioxidant Body Mist SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMELAN INC.66b7c899-46fd-41a6-9a96-ebbf2b68ea252024-05-02WarningsExact identifier
ndc (package): 84294-479-00
ndc (product): 84294-479
ndc11 (package): 84294047900
spl id: 177585c6-4678-6da2-e063-6294a90abbb4
spl set id: 66b7c899-46fd-41a6-9a96-ebbf2b68ea25

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.