Essence Pout Protector SPF 20 Lip Balm

Manufacturer
cosnova GmbH
Effective date
2024-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:49:34

Label at a glance#

ProductEssence Pout Protector SPF 20 Lip Balm
Active ingredientZINC OXIDE, HOMOSALATE, OCTISALATE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 7.3%

Octisalate 5.0%

Zinc Oxide 6.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

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

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

RICINUS COMMUNIS (CASTOR) SEED OIL, EUPHORBIA CERIFERA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX, BIS-DIGLYCERYL POLYACYLADIPATE-1, BUTYROSPERMUM PARKII (SHEA) BUTTER, RUBUS IDAEUS (RASPBERRY) SEED OIL, SYNTHETIC WAX, CAPRYLIC/CAPRIC TRIGLYCERIDE, C13-15 ALKANE, CETYL ALCOHOL, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA) WAX), MICA, SILICA, PARFUM (FRAGRANCE), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, POLYHYDROXYSTEARIC ACID, CAPRYLYL GLYCOL, HEXYLENE GLYCOL, HAEMATOCOCCUS PLUVIALIS EXTRACT, PHENOXYETHANOL, CI 15850 (RED 7), CI 77492 (IRON OXIDES).

You may report an adverse reaction to:

ADVERSE REACTIONS SECTION

cosnova USA Inc 55 5th Ave. New York, NY 10003, USA.

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84270-001-01Essence Pout Protector SPF 20 Lip Balm4 g in 1 TUBESTICK41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84270-001ESSENCE POUT PROTECTOR SPF 20 LIP BALM (HOMOSALATE, OCTISALATE, ZINC OXIDE) STICK [COSNOVA GMBH]1Current NDC, 1 package rows20250101_17e483c5-6e47-9a50-e063-6394a90aa604.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84270-00184270-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
Essence Pout Protector SPF 20 Lip BalmHOMOSALATE, OCTISALATE, ZINC OXIDEcosnova GmbH17e483c5-6e47-9a50-e063-6394a90aa6042024-05-07Warnings, Adverse reactionsExact identifier
ndc (package): 84270-001-01
ndc (product): 84270-001
ndc11 (package): 84270000101
spl id: 17e483c5-6e48-9a50-e063-6394a90aa604
spl set id: 17e483c5-6e47-9a50-e063-6394a90aa604

Reported adverse events (FAERS/openFDA)#

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