NDC 80554-001

BIORLX LIP BALM HEMP

Avobenzone, Mineral Oil, Octinoxate, Petrolatum,zinc Oxide

BIORLX LIP BALM HEMP is a Topical Stick in the Human Otc Drug category. It is labeled and distributed by Lotusa Llc. The primary component is Zinc Oxide; Octinoxate; Petrolatum; Mineral Oil; Avobenzone.

Product ID80554-001_af786d13-df27-6075-e053-2995a90a5115
NDC80554-001
Product TypeHuman Otc Drug
Proprietary NameBIORLX LIP BALM HEMP
Generic NameAvobenzone, Mineral Oil, Octinoxate, Petrolatum,zinc Oxide
Dosage FormStick
Route of AdministrationTOPICAL
Marketing Start Date2020-03-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameLOTUSA LLC
Substance NameZINC OXIDE; OCTINOXATE; PETROLATUM; MINERAL OIL; AVOBENZONE
Active Ingredient Strength6 g/100g; g/100g; g/100g; g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 80554-001-02

12 APPLICATOR in 1 BOX (80554-001-02) > 3.5 g in 1 APPLICATOR (80554-001-01)
Marketing Start Date2020-09-01
NDC Exclude FlagN
Sample Package?N

Drug Details


© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.