FDA.reportPublic FDA data

Lip Balm SPF15 Vanilla

Manufacturer
LS Promotions Inc
Effective date
2025-03-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:57:27

Label at a glance#

ProductLip Balm SPF15 Vanilla
Active ingredientOXYBENZONE, OCTISALATE
Label structure13 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15 minuts 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#

Lip Balm SPF15 Vanilla

DESCRIPTION SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Oxybenzone 4.7%

Octisalate 7.3%

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 right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minuts 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 the 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 10 AM to 2 PM
  • Wear long sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax, Petrolatum, Cerifera (Candelilla Wax), Flavor.

Questions or Comments?

OTC - QUESTIONS SECTION

Call weekdays from 9 AM to 5PM EST at 631-231-2300

LB100I Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LB100I Vanilla Label (NDC 72449-408-01) LB100 Vanilla LabelLB100 Vanilla Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72449-408-01Lip Balm SPF15 Vanilla4.2 g in 1 CYLINDERLIPSTICK4.23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72449-408LIP BALM SPF15 VANILLA (LIP BALM SPF15) LIPSTICK [LS PROMOTIONS INC]31 package rows20250322_30a4a5eb-81c7-e457-e063-6294a90a3137.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72449-40872449-408-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYBENZONE95OOS7VE0YACTIB
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
PETROLATUM4T6H12BN9UIACT
CETYL ESTERS WAXD072FFP9GUIACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
BEESWAX2ZA36H0S2VIACT
OCTISALATE4X49Y0596WACTIB

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
Lip Balm SPF15 VanillaLIP BALM SPF15LS Promotions Inc30a4a5eb-81c7-e457-e063-6294a90a31372025-03-18WarningsExact identifier
ndc (package): 72449-408-01
ndc (product): 72449-408
ndc11 (package): 72449040801
spl id: 30b8c7c8-ec54-8054-e063-6394a90acb44
spl set id: 30a4a5eb-81c7-e457-e063-6294a90a3137

Reported adverse events (FAERS/openFDA)#

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