FDA.reportPublic FDA data

MELAN SPF-30 Broad Spectrum Lotion

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 Broad Spectrum
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
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 8.00%

Octisalate 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 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?

OTC - QUESTIONS SECTION

1-888-676-3890

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84294-484-00MELAN SPF-30 Broad Spectrum100.55 mL in 1 TUBELOTION100.551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84294-484MELAN SPF-30 BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTISALATE) LOTION [MELAN INC.]1Current NDC, 1 package rows20240507_75fcef12-bc33-44a7-acda-77d5d7bca2bc.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84294-48484294-484-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
WATER059QF0KO0RIACT
DOCOSANOL9G1OE216XYIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETEARYL OLIVATE58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
WATERMELON231473QB6RIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
GRAPEFRUITO82C39RR8CIACT
COCONUT OILQ9L0O73W7LIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
DODECANE11A386X1QHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
LAURYL LACTATEG5SU0BFK7OIACT
PEPPERMINT OILAV092KU4JHIACT
BASIL2U0KZP0FDWIACT
RICE BRAN OILLZO6K1506AIACT
PANTHENOLWV9CM0O67ZIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
ROSEMARYIJ67X351P9IACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN OLIVATEMDL271E3GRIACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATEMELAN INC.75fcef12-bc33-44a7-acda-77d5d7bca2bc2024-05-02WarningsExact identifier
ndc (package): 84294-484-00
ndc (product): 84294-484
ndc11 (package): 84294048400
spl id: 177573a4-c184-2b48-e063-6394a90a9a55
spl set id: 75fcef12-bc33-44a7-acda-77d5d7bca2bc

Reported adverse events (FAERS/openFDA)#

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