NDC 58831-2001

EGF UV SHIELD

Oxtinoxate

EGF UV SHIELD is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Dermaesthetics Inc.. The primary component is Octinoxate; Octisalate; Zinc Oxide; Titanium Dioxide; Amiloxate.

Product ID58831-2001_705f9494-f60d-f5fb-e053-2991aa0adda4
NDC58831-2001
Product TypeHuman Otc Drug
Proprietary NameEGF UV SHIELD
Generic NameOxtinoxate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-07-07
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameDermaesthetics Inc.
Substance NameOCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE; AMILOXATE
Active Ingredient Strength8 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58831-2001-1

60 mL in 1 TUBE (58831-2001-1)
Marketing Start Date2018-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58831-2001-1 [58831200101]

EGF UV SHIELD CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-07

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE7.5 g/100mL

OpenFDA Data

SPL SET ID:705f9494-f60b-f5fb-e053-2991aa0adda4
Manufacturer
UNII

NDC Crossover Matching brand name "EGF UV SHIELD" or generic name "Oxtinoxate"

NDCBrand NameGeneric Name
58831-1001EGF UV SHIELDOCTINOXATE
58831-2001EGF UV SHIELDoxtinoxate

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