Tea Tree Lip Balm, SPF 15

Product NDC
63645-176
11-digit product format
636450176
Labeler code
63645
Product ID
63645-176_33dd4841-ac64-5d7a-e063-6394a90a4b98
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Oxybenzone
Dosage form
STICK
Route
TOPICAL
Labeler
OraLabs
Application
352
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-09
Substance
OCTINOXATE; OXYBENZONE
Active strength
20; 45 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
Tea Tree Lip Balm, SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE20 mg/g
OXYBENZONE45 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 95OOS7VE0Y

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63645-176-032025-04-28C16284748780-12cef2736-71ad-d83d-e063-dadaa90ab31fDrug Facts
63645-176-032025-01-30C16284748780-12cef2736-71ad-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-176-03Tea Tree Lip Balm, SPF 154 g in 1 CONTAINERSTICK43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-176TEA TREE LIP BALM, SPF 15 (OCTINOXATE, OXYBENZONE) STICK [ORALABS]3Current NDC, Legacy NDC, 1 package rows20250429_ce11b043-0290-4c18-afbc-df4e49656c31.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63645-176-03636450176034 g in 1 CONTAINER (63645-176-03) 4 g2017-10-090000-00-00NoNoCurrent