FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30- zinc oxide liquid

FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 by

Drug Labeling and Warnings

FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide 15%

Purpose

Sunscreen

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.

Warnings

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.

Keep out of reach of children

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

Directions

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

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

Inactive Ingredients

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

Call toll free 1-888-589-6243

Product Labeling

INGREDIENTS AND APPEARANCE

FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CI 45410 (UNII: 767IP0Y5NH)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
CITRUS LIMON (LEMON) PEEL OIL (UNII: I9GRO824LL)
SHEA BUTTER (UNII: K49155WL9Y)
CASTOR OIL (UNII: D5340Y2I9G)
CANDELILLA WAX (UNII: WL0328HX19)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CI 77499 (UNII: XM0M87F357)
CI 15850 (UNII: 481744AI4O)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
WATER (UNII: 059QF0KO0R)
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL (UNII: AKN3KSD11B)
ARGAN OIL (UNII: 4V59G5UW9X)
PORTULACA PILOSA WHOLE (UNII: II29C6E5R3)
SUCROSE COCOATE (UNII: 3H18P0UK73)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
ISOMALT (UNII: S870P55O2W)
PALMITOYL TRIPEPTIDE-38 (UNII: T7A529FB8O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1409-1	1 in 1 CARTON	01/14/2025
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/14/2025

Labeler - Peer Pharm Ltd. (514678390)