Kaplan MD Perfect Pout Lip Balm

Manufacturer
KAPLAN MD INC | KDC/ONE SOCAL LABORATORIES, LLC
Effective date
2024-05-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:11

Label at a glance#

ProductKaplan MD Perfect Pout Lip Balm
Active ingredientOCTOCRYLENE, OCTINOXATE, OCTISALATE
Label structure12 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Octisalate 5%

Octocrylene 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

Do not use on damaged and broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

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

Other Information

OTHER SAFETY INFORMATION

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

Directions

INDICATIONS & USAGE SECTION

  • 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

INACTIVE INGREDIENT SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

apply generously to lips 15 minutes before sun exposure

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KMDLBKMDLB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84300-001-10Kaplan MD Perfect Pout Lip Balm10 g in 1 TUBE, WITH APPLICATORLIPSTICK101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84300-001KAPLAN MD PERFECT POUT LIP BALM (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LIPSTICK [KAPLAN MD INC]11 package rows20240509_17f859d3-5849-a291-e063-6294a90a0f85.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84300-00184300-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 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
17f859d3-584a-a291-e063-6294a90a0f8517f859d3-5849-a291-e063-6294a90a0f852024-05-08WarningsExact identifier
spl id: 17f859d3-584a-a291-e063-6294a90a0f85
spl set id: 17f859d3-5849-a291-e063-6294a90a0f85

Reported adverse events (FAERS/openFDA)#

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