FDA.reportPublic FDA data

MediChoice Moisturizing Lip Balm SPF15

Manufacturer
O&M HALYARD, INC. | Owens & Minor, Inc
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:38:14

Label at a glance#

ProductMediChoice Moisturizing Lip Balm SPF15
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
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 Children under 6 months of age: Ask a doctor  Sun Protection Measures 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 ...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

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

OTC - DO NOT USE SECTION

  • on damaged or broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Sun Protection MeasuresSpending 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 10a.m.-2p.m.
  • wear long sleeved shirts, pants hats, and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Petrolatum, Mineral Oil, Paraffin Wax, Ozokerite Wax, Coconut Oil, Tocopherol, Soybean Oil.

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Package Labeling:39892-0940-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

Package Labeling:39892-0940-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02Label02

Package Labeling:39892-0940-3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label03Label03

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)20885632142281GTIN-14: 20885632142281
GTIN storage (14 digits): 20885632142281		Label02.jpg
Data codeCode 12830885632142288Label03.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39892-0940-1MediChoice Moisturizing Lip Balm SPF154.2 g in 1 POUCHCREAM4.23
39892-0940-2MediChoice Moisturizing Lip Balm SPF15100 in 1 BOXCREAM1003
39892-0940-2MediChoice Moisturizing Lip Balm SPF154.2 g in 1 CASECREAM4.23
39892-0940-3MediChoice Moisturizing Lip Balm SPF154.2 g in 1 CASECREAM4.23
39892-0940-3MediChoice Moisturizing Lip Balm SPF15100 in 1 BOXCREAM1003

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
39892-094039892-0940-1, 39892-0940-2, 39892-0940-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
CERESINQ1LS2UJO3AIACT
COCONUT OILQ9L0O73W7LIACT
TOCOPHEROLR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-06-11full-release2026-06-01 01:02:49
12023-10-30full-release2026-05-31 23:58:28

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
MediChoice Moisturizing Lip Balm SPF15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEO&M HALYARD, INC.00327815-28f0-4198-bca7-c8ae768ff4162025-10-09WarningsExact identifier
ndc (package): 39892-0940-1
ndc (package): 39892-0940-3
ndc (package): 39892-0940-2
ndc (product): 39892-0940
ndc11 (package): 39892094001
ndc11 (package): 39892094002
ndc11 (package): 39892094003
spl id: 40b41656-3e4a-5597-e063-6394a90a952a
spl set id: 00327815-28f0-4198-bca7-c8ae768ff416

Reported adverse events (FAERS/openFDA)#

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