Lip Balm SPF 15

Product NDC
83657-600
11-digit product format
836570600
Labeler code
83657
Product ID
83657-600_20c5fde7-ee90-4b74-e063-6394a90a93ec
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, Octisalate, Octocrylene
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Skin Script, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-03
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength
.002; .0065; .005; .0015 g/g; g/g; g/g; g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lip Balm SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE.002 g/g
OCTINOXATE.0065 g/g
OCTISALATE.005 g/g
OCTOCRYLENE.0015 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 4Y5P7MUD51, 4X49Y0596W, 5A68WGF6WM

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
83657-600-01Lip Balm SPF 154.25 g in 1 TUBELIPSTICK4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83657-600LIP BALM SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) LIPSTICK [SKIN SCRIPT, LLC]1Current NDC, 1 package rows20240903_20c5fde7-ee8f-4b74-e063-6394a90a93ec.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83657-600-01836570600014.25 g in 1 TUBE (83657-600-01) 4.25 g2024-09-03NoNoHistorical