NDC 80554-003

BIORLX LIP BALM GINSENG

Avobenzone, Mineral Oil, Octinoxate, Petrolatum, Zinc Oxide

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

Product ID80554-003_af9b4ace-650c-dd55-e053-2a95a90a965f
NDC80554-003
Product TypeHuman Otc Drug
Proprietary NameBIORLX LIP BALM GINSENG
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 NameAVOBENZONE; OCTINOXATE; ZINC OXIDE; PETROLATUM; MINERAL OIL
Active Ingredient Strength1 g/100g; g/100g; g/100g; g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 80554-003-02

12 APPLICATOR in 1 BOX (80554-003-02) > 3.5 g in 1 APPLICATOR (80554-003-01)
Marketing Start Date2020-09-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "BIORLX LIP BALM GINSENG" or generic name "Avobenzone, Mineral Oil, Octinoxate, Petrolatum, Zinc Oxide"

NDCBrand NameGeneric Name
80554-003BIORLX LIP BALM GINSENGAvobenzone, Mineral Oil, Octinoxate, Petrolatum, Zinc Oxide
80554-002BIORLX LIP BALM COLLAGENAvobenzone, Mineral Oil, Octinoxate, Petrolatum, Zinc Oxide

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