NDC 61619-866

Pro-Tect Sunscreen for Professionals

Meradimate, Octinoxate, Octisalate, Oxybenzone

Pro-Tect Sunscreen for Professionals is a Cutaneous Lotion in the Human Otc Drug category. It is labeled and distributed by A-cute Derm, Incorporated. The primary component is Octinoxate; Meradimate; Oxybenzone; Octisalate.

Product ID61619-866_2abbf728-649f-02a4-e054-00144ff8d46c
NDC61619-866
Product TypeHuman Otc Drug
Proprietary NamePro-Tect Sunscreen for Professionals
Generic NameMeradimate, Octinoxate, Octisalate, Oxybenzone
Dosage FormLotion
Route of AdministrationCUTANEOUS
Marketing Start Date2016-02-08
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameA-Cute Derm, Incorporated
Substance NameOCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE
Active Ingredient Strength75 mg/mL; mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61619-866-01

29.6 mL in 1 BOTTLE, PLASTIC (61619-866-01)
Marketing Start Date2016-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61619-866-04 [61619086604]

Pro-Tect Sunscreen for Professionals LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-08

NDC 61619-866-01 [61619086601]

Pro-Tect Sunscreen for Professionals LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-08

NDC 61619-866-32 [61619086632]

Pro-Tect Sunscreen for Professionals LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-08

NDC 61619-866-06 [61619086606]

Pro-Tect Sunscreen for Professionals LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-08
Marketing End Date2016-02-01

NDC 61619-866-02 [61619086602]

Pro-Tect Sunscreen for Professionals LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-08

NDC 61619-866-08 [61619086608]

Pro-Tect Sunscreen for Professionals LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-08

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE75 mg/mL

OpenFDA Data

SPL SET ID:9604b7d9-d7fc-4cce-ad11-befb7c281fff
Manufacturer
UNII

NDC Crossover Matching brand name "Pro-Tect Sunscreen for Professionals" or generic name "Meradimate, Octinoxate, Octisalate, Oxybenzone"

NDCBrand NameGeneric Name
37945-860Pro-Tect Sunscreen for ProfessionalsMeradimate, Octinoxate, Octisalate, Oxybenzone
61619-866Pro-Tect Sunscreen for ProfessionalsMeradimate, Octinoxate, Octisalate, Oxybenzone
37945-862Pro-Tect Sports SunscreenMeradimate, Octinoxate, Octisalate, Oxybenzone
61619-864Pro-Tect Sports Sunscreen SPF 20Meradimate, Octinoxate, Octisalate, Oxybenzone
68605-8640Pro-Tect Sports Sunscreen SPF 20Meradimate, Octinoxate, Octisalate, Oxybenzone

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