NDC 57718-120

MELA DEFENSE WHITE ESSENCE

Dimethicone

MELA DEFENSE WHITE ESSENCE is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Mizon Co., Ltd.. The primary component is Dimethicone.

Product ID57718-120_87cce6cd-55eb-492d-a5ab-62a1100632f7
NDC57718-120
Product TypeHuman Otc Drug
Proprietary NameMELA DEFENSE WHITE ESSENCE
Generic NameDimethicone
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2016-03-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameMIZON CO., LTD.
Substance NameDIMETHICONE
Active Ingredient Strength1 g/50mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 57718-120-02

1 BOTTLE, PLASTIC in 1 CARTON (57718-120-02) > 50 mL in 1 BOTTLE, PLASTIC (57718-120-01)
Marketing Start Date2016-03-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57718-120-02 [57718012002]

MELA DEFENSE WHITE ESSENCE GEL
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-03-02
Inactivation Date2020-01-31

NDC 57718-120-01 [57718012001]

MELA DEFENSE WHITE ESSENCE GEL
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-03-02

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE1.05 g/50mL

OpenFDA Data

SPL SET ID:098f21a1-7bc8-49ea-8804-cad310d3136e
Manufacturer
UNII

NDC Crossover Matching brand name "MELA DEFENSE WHITE ESSENCE" or generic name "Dimethicone"

NDCBrand NameGeneric Name
57718-120MELA DEFENSE WHITE ESSENCEMELA DEFENSE WHITE ESSENCE
0132-0326Boudreauxs Butt BarrierDimethicone
0187-2218CeraVeDimethicone
0187-2219CeraVedimethicone
0187-2489CeraVedimethicone
0299-4114Cetaphil Cracked Skin RepairDimethicone
0299-4115Cetaphil Cracked Skin Repair BalmDimethicone
0573-1935CHAPSTICK OVERNIGHTdimethicone
0363-2247Daily BabyDimethicone
0869-0354Daily BabyDimethicone
0869-0496Daily BabyDimethicone
0869-0619Daily MoisturizingDimethicone
0363-5345Infants Gas ReliefDimethicone
0363-5773Infants Gas ReliefDIMETHICONE
0259-2202Mederma PMDimethicone
0259-2102Mederma Stretch Marks Therapydimethicone
0093-3204MoisturelDimethicone
0430-3100MoisturelDimethicone
10742-7005Softlipsdimethicone
10742-7002Softlips Cherry, Raspberry, Vanilladimethicone
10742-7003Softlips Watermelon, Tropical Coconut, Peach Passiondimethicone
0132-8744Summers Eve Active ChafeDimethicone
0187-1660TheraSealDimethicone
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