FDA.reportPublic FDA data

Lip Balm

Manufacturer
LS Promotions Inc
Effective date
2021-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:50

Label at a glance#

ProductLip Balm
Active ingredientOCTISALATE, OCTOCRYLENE, OCTINOXATE, AVOBENZONE
Label structure13 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Drug Fact

DESCRIPTION SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not Use on Damaged or Broken Skin

Stop Use and Ask a Doctor

OTC - STOP USE SECTION

If rash occurs

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INSTRUCTIONS FOR USE SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months of age: Ask a doctor

Sun Protection Measures

SPL UNCLASSIFIED SECTION

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 including: Limit time in the sun, especially from 10am to 2pm. Wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, mineral oil, paraffin wax, osokerite wax, coconut oil, tocopherol

Questions or Comments

OTC - QUESTIONS SECTION

Call weekdays from 9am to 5pm EST at 631-231-2300

Image of package PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LB100 Lip Balm SPF15_Unflavored 6-14-2021LB100 Lip Balm SPF15_Unflavored 6-14-2021Image of label for Lip Balm with SPF15 unflavored

NDC # 72449-200-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72449-200-012025-01-30C16284748780-12cef2736-b575-d83d-e063-dadaa90ab31fLip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72449-200-01Lip Balm4.25 g in 1 TUBELIPSTICK4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72449-200LIP BALM LIPSTICK [LS PROMOTIONS INC]1Legacy NDC, 1 package rows20210616_c4bbc742-9fb1-14e3-e053-2995a90ac478.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72449-20072449-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WHITE PETROLATUMB6E5W8RQJ4IACT
PARAFFINI9O0E3H2ZEIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CERESINQ1LS2UJO3AIACT
MINERAL OILT5L8T28FGPIACT
OCTINOXATE4Y5P7MUD51ACTIB
COCONUT OILQ9L0O73W7LIACT
TOCOPHEROLR0ZB2556P8IACT
AVOBENZONEG63QQF2NOXACTIB

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
c4bbc742-9fb2-14e3-e053-2995a90ac478c4bbc742-9fb1-14e3-e053-2995a90ac4782021-06-14WarningsExact identifier
spl id: c4bbc742-9fb2-14e3-e053-2995a90ac478
spl set id: c4bbc742-9fb1-14e3-e053-2995a90ac478

Reported adverse events (FAERS/openFDA)#

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