XBALM EXTREME ORANGE

Product NDC
10827-2004
11-digit product format
108272004
Labeler code
10827
Product ID
10827-2004_5f8e2cc3-40a0-f5fa-e063-6394a90ae837
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE AND OXYBENZONE
Dosage form
STICK
Route
TOPICAL
Labeler
Yusef Manufacturing Laboratories
Application
part352
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-01-01
Substance
OCTINOXATE; OXYBENZONE
Active strength
.294; .168 g/4.2g; g/4.2g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
XBALM EXTREME ORANGE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE.294 g/4.2g
OXYBENZONE.168 g/4.2g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d55cab7-5cd6-4c07-abb7-45de8d0d5fb6Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10827-2004-1108272004014.2 g in 1 TUBE (10827-2004-1) 4.2 g2006-01-01NoNoCurrent