KAPLAN MD PERFECT POUT LIP BALM- octinoxate, octisalate, octocrylene lipstick

Kaplan MD Perfect Pout Lip Balm by

Drug Labeling and Warnings

Kaplan MD Perfect Pout Lip Balm by is a Otc medication manufactured, distributed, or labeled by KAPLAN MD INC, KDC/ONE SOCAL LABORATORIES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5%

Octisalate 5%

Octocrylene 3%

Purpose

Sunscreen

Warnings

For external use only.

Skin Cancer/Skin Agung Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to help prevent sunburn, not skin cancer or early skin aging.

DO NOT USE

Do not use on damaged and broken skin.

STOP USE

Stop use and ask a doctor if rash occurs.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

Other Information

• protect the product in this container from excessive heat and direct sun

Directions

• apply generously to lips 15 minutes before sun exposure
• children under 6 months of age: Ask a doctor
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating

Inactive Ingredients

Hydrogenated Polyisobutene, Ethylhexyl Methoxycinnamate, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Salicylate, Ethylhexyl Palmitate,Octocrylene, Octyldodecanol, Polyisobutene, Silica Silylate, Caprylyl Methicone, Helianthus Annuus (Sunflower) Seed Wax, Rebaudioside A, Sodium Hyaluronate, Palmitoyl Tripeptide-1, Euphorbia Cerifera Cera, Carthamus Tinctorius (Safflower) Oleoseomes, Beeswax, Aloe Barbadensis Leaf Extract*, Camellia Sinensis (Green Tea) Extract*, Salvia Officinalis (Sage) Extract*, Pelargonium Graveolens (Rose Geranium) Extract*, Melissa Officinalis (Lemon Balm) Extract*, Ginkgo Biloba Extract*, Lavandula lntermedia (Lavender) Extract*, Rosmarinus Officinalis (Rosemary) Extract*, Mentha Piperita (Peppermint) Extract*,Thymus Vulgaris (Thyme) Extract*, Chamomilla Recutita (Matricaria) Extract*,Trifolium Pratense (Red Clover) Extract*, Rosa Canina (Rose Hips) Extract*, Baraga Officinalis (Borage) Extract*, Macrocystis Pyrifera (Kelp) Extract*, Panax Ginseng Root Extract*, Camellia Sinensis (White Tea) Extract*, llex Paraguariensis (Yerba Mate) Extract*,Lippia Citriodora (Lemon Verbena) Extract*, Citrus Grandis (Grapefruit) Extract*, Sambucus Nigra (Elderflower) Extract*, Fucus Vesiculosus (Seaweed) Extract*, Phenoxyethanol, Tocopheryl Acetate, Butylene/Ethylene/Styrene Copolymer, Caprylyl Glycol, Tetrahexyldecyl Ascorbate, Ethylhexylglycerin, Hexylene Glycol, Tribehenin, Glyceryl Caprylate, Sorbitan lsostearate, Silica Dimethyl Silylate, BHT, Butylene Glycol, Pentylene Glycol, Glycerin, Mentha Piperita (Peppermint) Oil, Aqua.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

apply generously to lips 15 minutes before sun exposure

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KAPLAN MD PERFECT POUT LIP BALM 
octinoxate, octisalate, octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84300-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
RED CLOVER (UNII: L9153EKV2Y)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
WATER (UNII: 059QF0KO0R)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
REBAUDIOSIDE A (UNII: B3FUD0528F)
ROSEMARY (UNII: IJ67X351P9)
SAGE (UNII: 065C5D077J)
LEMON BALM OIL (UNII: MJ76269K9S)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
BORAGE (UNII: PB618V0K2W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WHITE TEA (UNII: O0M3396E09)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
GRAPEFRUIT (UNII: O82C39RR8C)
THYME (UNII: CW657OBU4N)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEPPERMINT (UNII: V95R5KMY2B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL CAPRATE (UNII: 197M6VFC1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84300-001-10	10 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	05/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/08/2024

Labeler - KAPLAN MD INC (782764638)

Registrant - KDC/ONE SOCAL LABORATORIES, LLC (118384240)

Establishment
Name	Address	ID/FEI	Business Operations
KDC/ONE SOCAL LABORATORIES, LLC		118384240	manufacture(84300-001)