FDA.reportPublic FDA data

ChapIce Moisture SPF 15 Lip Balm

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2025-04-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:00:05

Label at a glance#

ProductChapIce Moisture SPF 15 Lip Balm
Active ingredientOCTINOXATE, OXYBENZONE, PETROLATUM
Label structure8 sections

Indications and uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

Dosage and administration

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate (7.5%), Oxybenzone (3.5%)

Petrolatum (40.7%)

Purpose

OTC - PURPOSE SECTION

Sunscreen, Sunscreen, Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Helps prevent and temporarily protects dry, chapped or windburned lips.

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 prevent sunburn, not skin cancer or early aging.

For external use only

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally before sun exposure and as needed.

Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ozokerite, Mineral Oil, Isocetyl Stearate, Microcrystalline Wax, Isopropyl Lanolate, Lanolin, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Isopropyl Myristate, Aloe Barbadenis Leaf Extract, Paraffin, Cetyl Alcohol, Tocerpheryl Linoleate, Flavor, Methylparaben, Propylparaben.

Questions?

OTC - QUESTIONS SECTION

1-800-290-0577

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carded Chap Ice Lip Balm

Carded Chap Ice Lip BalmCarded Chap Ice Lip Balm

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-180-012023-03-15C16284748780-1f386c649-aed0-0266-e053-dadaa90a7c1aChap Ice Lip Balm
67751-180-012023-01-30C16284748780-1f386c649-aed0-0266-e053-dadaa90a7c1aChap Ice Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-180-01ChapIce Moisture SPF 15 Lip Balm1 in 1 PACKAGESTICK15
67751-180-01ChapIce Moisture SPF 15 Lip Balm4.25 g in 1 CONTAINERSTICK4.255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-180CHAPICE MOISTURE SPF 15 LIP BALM (OXYBENZONE, OCTINOXATE, PETROLATUM) STICK [NAVAJO MANUFACTURING COMPANY INC.]5Current NDC, Legacy NDC, 2 package rows20250501_60ce1a8c-180a-161e-e053-2991aa0ae981.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
67751-18067751-180-01
63645-140

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERESINQ1LS2UJO3AIACT
ISOCETYL STEARATE3RJ7186O9WIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LIGHT MINERAL OILN6K5787QVPIACT
LANOLIN7EV65EAW6HIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
PETROLATUM4T6H12BN9UACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMOraLabs1fcc1d6e-71b8-4f2f-8794-b3d013ad4ea72025-05-07WarningsExact identifier
ndc (product): 63645-140
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMNavajo Manufacturing Company Inc.60ce1a8c-180a-161e-e053-2991aa0ae9812025-04-29WarningsExact identifier
ndc (package): 67751-180-01
ndc (product): 67751-180
ndc11 (package): 67751018001
spl id: 33f23cb9-7511-005b-e063-6394a90a35ec
spl set id: 60ce1a8c-180a-161e-e053-2991aa0ae981

Reported adverse events (FAERS/openFDA)#

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