FDA.reportPublic FDA data

Mele

Manufacturer
CONOPCO Inc. d/b/a Unilever
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:35:58

Label at a glance#

ProductMele Men plus Care Hydrate Face
Active ingredientOCTINOXATE, AVOBENZONE
Label structure10 sections

Indications and uses

Help prevent sunburn If used as directed with other sun protectionmeaseure (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply to all skin exposed to the sun Apply liberally and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this rish, regularly use a sunscreen with a Broad Spectum SPF value of 15 or higher and other sun protection measures...

Label contents#

Full prescribing information#

MELĒ DEW THE MOST SHEER MOISTURIZER SUNSCREEN SPF 30 - (sunscreen, avobenzone, octinoxate) lotion

DESCRIPTION SECTION

Melē Dew The Most Sheer Moisturizer Sunscreen SPF 30

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Avobenzone 2%
Octinoxate 3.99%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Help prevent sunburn
If used as directed with other sun protectionmeaseure (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 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 occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children
If product is swallowed, get medical help or contact a PoisonCcontrol Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to all skin exposed to the sun
Apply liberally and evenly 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this rish, regularly use a sunscreen with a Broad Spectum SPF value of 15 or higher and other sun protection measures including

limit time in the sun, especiallu from 10a.m. - 2p.m.

wear long-sleeved shirts, pants, hats and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Butyloctyl Salicylate, Glycerin, Isohexadecane, Carthamus Tinctorius (Safflower) Oleosomes, Niacinamide, Dimethicone, C12-15 Alkyl Benzoate, Polyglyceryl-10 Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Theobroma Cacao (Cocoa) Seed Extract, Dimethicone Crosspolymer, Xanthan Gum, Fragrance (Parfum), Butylene Glycol, Citric Acid, Sodium Benzoate, Tocopheryl Acetate, Coumarin, Hexyl Cinnamal, Limonene. Linalool.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-621-2079

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MeleMoisturizerSunscreenSPF30MeleMoisturizerSunscreenSPF30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64942-1857-1MeleMen plus Care Hydrate Face29.57 mL in 1 TUBELOTION29.573
64942-1857-2MeleMen plus Care Hydrate Face1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64942-1857MELE MEN PLUS CARE HYDRATE FACE (DEW THE MOST SHEER MOISTURIZER SUNSCREEN) LOTION [CONOPCO INC. D/B/A UNILEVER]3Current NDC, Legacy NDC, 2 package rows20241109_bb27185b-5732-a648-e053-2a95a90aa930.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64942-185764942-1857-1, 64942-1857-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
NIACINAMIDE25X51I8RD4IACT
COUMARINA4VZ22K1WTIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
COCOAD9108TZ9KGIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
WATER059QF0KO0RIACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
XANTHAN GUMTTV12P4NEEIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
DIMETHICONE92RU3N3Y1OIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT

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
Mele Men plus Care Hydrate FaceDEW THE MOST SHEER MOISTURIZER SUNSCREENCONOPCO Inc. d/b/a Unileverbb27185b-5732-a648-e053-2a95a90aa9302024-11-07WarningsExact identifier
ndc (package): 64942-1857-1
ndc (package): 64942-1857-2
ndc (product): 64942-1857
ndc11 (package): 64942185702
ndc11 (package): 64942185701
spl id: 26521992-2555-c88b-e063-6394a90a8c40
spl set id: bb27185b-5732-a648-e053-2a95a90aa930

Reported adverse events (FAERS/openFDA)#

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