NDC 71070-768

JACKET SPF 50

Zinc Oxide, Octinoxate, Octisalate, Octisalate

JACKET SPF 50 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Balshi Md Dermaceuticals. The primary component is Zinc Oxide; Octinoxate; Octisalate; Oxybenzone.

Product ID71070-768_41975214-a27a-41f4-e054-00144ff8d46c
NDC71070-768
Product TypeHuman Otc Drug
Proprietary NameJACKET SPF 50
Generic NameZinc Oxide, Octinoxate, Octisalate, Octisalate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-11-18
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameBalshi MD Dermaceuticals
Substance NameZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active Ingredient Strength75 mg/g; mg/g; mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71070-768-04

1 BOTTLE in 1 CARTON (71070-768-04) > 113 g in 1 BOTTLE
Marketing Start Date2016-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71070-768-04 [71070076804]

JACKET SPF 50 CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-11-18

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE75 mg/g

OpenFDA Data

SPL SET ID:b82b8a46-8009-416e-8718-296a23106914
Manufacturer
UNII

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