NDC 61369-201

KLENSKIN BROAD SPECTRUM SPF-50

Avobenzone, Octocrylene, Octinoxate

KLENSKIN BROAD SPECTRUM SPF-50 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Colabs Intl. Corp. The primary component is Avobenzone; Octocrylene; Octinoxate.

Product ID61369-201_77efb622-ff6a-453c-a59d-223e7eba1d79
NDC61369-201
Product TypeHuman Otc Drug
Proprietary NameKLENSKIN BROAD SPECTRUM SPF-50
Generic NameAvobenzone, Octocrylene, Octinoxate
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2016-04-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameCoLabs Intl. Corp
Substance NameAVOBENZONE; OCTOCRYLENE; OCTINOXATE
Active Ingredient Strength2 g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61369-201-12

56 mL in 1 BOTTLE (61369-201-12)
Marketing Start Date2016-04-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61369-201-12 [61369020112]

KLENSKIN BROAD SPECTRUM SPF-50 LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-04-16

NDC 61369-201-14 [61369020114]

KLENSKIN BROAD SPECTRUM SPF-50 LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-27

NDC 61369-201-32 [61369020132]

KLENSKIN BROAD SPECTRUM SPF-50 LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-10

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE2.1 g/100mL

OpenFDA Data

SPL SET ID:63fec681-5957-49cc-8b9e-97c4819ce097
Manufacturer
UNII

NDC Crossover Matching brand name "KLENSKIN BROAD SPECTRUM SPF-50" or generic name "Avobenzone, Octocrylene, Octinoxate"

NDCBrand NameGeneric Name
81901-001EB Epicurus SPF 50 The SunscreenAVOBENZONE, OCTOCRYLENE, OCTINOXATE
61369-201KLENSKIN BROAD SPECTRUMAVOBENZONE, OCTOCRYLENE, OCTINOXATE
61369-102KLENSKIN KIDS SHOWERON SUNSCREENAVOBENZONE, OCTOCRYLENE, OCTINOXATE
61369-101KLENSKIN SHOWERON SUNSCREENAVOBENZONE, OCTOCRYLENE, OCTINOXATE
61369-103KLENSKIN SHOWERON SUNSCREEN SPAAVOBENZONE, OCTOCRYLENE, OCTINOXATE

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