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

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Kaplan MD Perfect Pout Lip Balm (Pink Peony)

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, notskin cancer or early skin aging.

Do not use ondamaged and broken skin.

Stop use and ask a doctorif rash occurs.

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

Other Information

Directions

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.

apply generously to lips 15 minutes before sun exposure

KMDLB

KAPLAN MD PERFECT POUT LIP BALM PINK PEONY 
octinoxate, octisalate, octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84300-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84300-002-1010 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product05/08/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/08/2024
Labeler - KAPLAN MD INC (782764638)
Registrant - KDC/ONE SOCAL LABORATORIES, LLC (118384240)
Establishment
NameAddressID/FEIBusiness Operations
KDC/ONE SOCAL LABORATORIES, LLC118384240manufacture(84300-002)

Revised: 5/2024
Document Id: 17fa7be5-9a2f-4929-e063-6294a90a60d8
Set id: 17fa7be5-9a2e-4929-e063-6294a90a60d8
Version: 1
Effective Time: 20240508
 
KAPLAN MD INC