NDC 54473-281

Sei Bella CC Brightening Creme Medium

Octinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%

Sei Bella CC Brightening Creme Medium is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Melaleuca Inc.. The primary component is Titanium Dioxide; Octinoxate; Zinc Oxide.

Product ID54473-281_68a4e3f5-f84e-5650-e053-2a91aa0a171d
NDC54473-281
Product TypeHuman Otc Drug
Proprietary NameSei Bella CC Brightening Creme Medium
Generic NameOctinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2017-05-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameMelaleuca Inc.
Substance NameTITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE
Active Ingredient Strength2 g/33mL; g/33mL; g/33mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54473-281-01

1 BOTTLE, DISPENSING in 1 BOX (54473-281-01) > 33 mL in 1 BOTTLE, DISPENSING (54473-281-30)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54473-281-01 [54473028101]

Sei Bella CC Brightening Creme Medium LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01
Inactivation Date2020-01-31
Reactivation Date2020-03-19

NDC 54473-281-30 [54473028130]

Sei Bella CC Brightening Creme Medium LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-01

Drug Details

Active Ingredients

IngredientStrength
TITANIUM DIOXIDE1.65 g/33mL

OpenFDA Data

SPL SET ID:68a4ed34-f492-67a6-e053-2a91aa0a0428
Manufacturer
UNII

NDC Crossover Matching brand name "Sei Bella CC Brightening Creme Medium" or generic name "Octinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%"

NDCBrand NameGeneric Name
54473-279Sei Bella CC Brightening CremeOctinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%
54473-280Sei Bella CC Brightening CremeOctinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%
54473-281Sei Bella CC Brightening CremeOctinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%
54473-282Sei Bella CC Brightening CremeOctinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.