FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30

Manufacturer
Peer Pharm Ltd.
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:02

Label at a glance#

ProductFRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

• Helps prevent sunburn. • 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. • 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 this risk, regularly use a sunscreen with a broad-spectrum SPF value of 15 or higher and other sun protection measures. • Limit tim...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

DOSAGE & ADMINISTRATION SECTION

• Helps prevent sunburn. • 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 on damaged or broken skin.
• When using this product, keep out of eyes.
Rinse with water to remove.

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

if rash occurs.

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.

Directions

INDICATIONS & USAGE SECTION

• Apply liberally 15 minutes before sun exposure.
• 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 this risk, regularly use a
sunscreen with a broad-spectrum SPF value of 15
or higher and other sun protection measures.
• Limit time in the sun, especially from 10 a.m.- 2 p.m.
• Wear long-sleeved shirts, pants, hats, and
sunglasses.
• For children under 6 months of age: Ask a doctor.

Other information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ricinus Communis (Castor) Seed Oil, Caprylic/Capric
Triglyceride, Polybutene, Butyrospermum Parkii
(Shea) Butter, Butyloctyl Salicylate,Euphorbia Cerifera
(Candelilla) Wax, Hydrogenated Rapeseed Oil,
Isodecyl Neopentanoate, Argania Spinosa Kernel Oil,
C10-18 Triglyceride, Polyhydroxystearic Acid,
Triethoxycaprylylsilane, Water, Citrus Aurantium
Dulcis Peel Oil, Citrus Limon (Lemon) Peel Oil,
Glycerin, Argania Spinosa Leaf Extract, Argania
Spinosa Callus Culture Extract, Isomalt, Lecithin,
Cetearyl Ethylhexanoate, Sorbitan Isostearate,
Portulaca Pilosa Extract, Sucrose Cocoate, Palmitoyl
Tripeptide-38, Alcohol, Synthetic Wax, Isopropyl
Titanium Triisostearate, Red 27 Lake (CI 45410),
Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron
Oxides (CI 77499), Red 6 Lake (CI 15850).

Questions & Comments

OTC - QUESTIONS SECTION

Call toll free 1-888-589-6243

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1409-1FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 3015 mL in 1 TUBELIQUID153
69435-1409-1FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 301 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1409FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 (ZINC OXIDE) LIQUID [PEER PHARM LTD.]3Current NDC, 2 package rows20250131_2baf0278-7e13-4db0-e063-6294a90ae9de.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69435-140969435-1409-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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
FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30ZINC OXIDEPeer Pharm Ltd.2baf0278-7e13-4db0-e063-6294a90ae9de2025-01-30WarningsExact identifier
ndc (package): 69435-1409-1
ndc (product): 69435-1409
ndc11 (package): 69435140901
spl id: 2ce979eb-527c-9100-e063-6294a90ac067
spl set id: 2baf0278-7e13-4db0-e063-6294a90ae9de

Reported adverse events (FAERS/openFDA)#

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