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 structure11 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. For children under 6 months of age. Ask a doctor. 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 v...

Label contents#

Full prescribing information#

MELĒ NO SHADE SUNSCREEN OIL SPF 30 - (sunscreen, avobenzone, octinoxate) oil

DESCRIPTION SECTION

Melē No Shade Sunscreen Oil SPF 30

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Avobenzone 3%
Octinoxate 7.49%

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.
For children under 6 months of age. Ask a doctor.
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

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Octyldodecanol, Isohexadecane, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dimethicone, Butyloctyl Salicylate, Ethylcellulose, Fragrance (Parfum), Coumarin, Limonene, Linalool.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-621-2079

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mele SPF 30 Sunscreen OilMele SPF 30 Sunscreen Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64942-1858-1MeleMen plus Care Hydrate Face29.57 mL in 1 BOTTLE, DROPPEROIL29.573
64942-1858-2MeleMen plus Care Hydrate Face1 in 1 CARTONOIL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64942-1858MELE MEN PLUS CARE HYDRATE FACE (NO SHADE SUNSCREEN OIL) OIL [CONOPCO INC. D/B/A UNILEVER]3Current NDC, Legacy NDC, 2 package rows20241109_bb2921bc-8892-1db2-e053-2995a90ae28c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64942-185864942-1858-1, 64942-1858-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTYLDODECANOL461N1O614YIACT
ISOHEXADECANE918X1OUF1EIACT
DIMETHICONE92RU3N3Y1OIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ETHYLCELLULOSES7Z8S9VYZ4BIACT
COUMARINA4VZ22K1WTIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB

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 FaceNO SHADE SUNSCREEN OILCONOPCO Inc. d/b/a Unileverbb2921bc-8892-1db2-e053-2995a90ae28c2024-11-07WarningsExact identifier
ndc (package): 64942-1858-2
ndc (package): 64942-1858-1
ndc (product): 64942-1858
ndc11 (package): 64942185801
ndc11 (package): 64942185802
spl id: 26521234-dfca-01b7-e063-6394a90a1567
spl set id: bb2921bc-8892-1db2-e053-2995a90ae28c

Reported adverse events (FAERS/openFDA)#

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