ChapIce SPF 30 Lip Balm

Product NDC
63645-163
11-digit product format
636450163
Labeler code
63645
Product ID
63645-163_3493d6b8-a3f9-3f4f-e063-6394a90a5d3d
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octocrylene, Oxybenzone, Octisalate
Dosage form
STICK
Route
TOPICAL
Labeler
OraLabs
Application
352
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-09
Substance
OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
7.5; 5; 10; 5 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ChapIce SPF 30 Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 mg/g
OCTISALATE5 mg/g
OCTOCRYLENE10 mg/g
OXYBENZONE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 4X49Y0596W, 5A68WGF6WM, 95OOS7VE0Y

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63645-163-012025-05-07C16284748780-12cef2736-75e3-d83d-e063-dadaa90ab31fDrug Facts
63645-163-012025-01-30C16284748780-12cef2736-75e3-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-163-01ChapIce SPF 30 Lip Balm1 g in 1 CONTAINERSTICK13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-163CHAPICE SPF 30 LIP BALM (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE) STICK [ORALABS]3Current NDC, Legacy NDC, 1 package rows20250509_49a00692-1577-4f74-9c64-73ac9791e63f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63645-163-01636450163011 g in 1 CONTAINER (63645-163-01) 1 g2017-10-090000-00-00NoNoCurrent