NDC 65008-004

Key West Tan SPF15

Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene

Key West Tan SPF15 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Qs Key West Aloe, Llc. The primary component is Avobenzone; Octinoxate; Octisalate; Octocrylene; Oxybenzone.

Product ID65008-004_1710f9e8-4481-4aae-b09c-d21f64cc5613
NDC65008-004
Product TypeHuman Otc Drug
Proprietary NameKey West Tan SPF15
Generic NameOctinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2004-07-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameQS Key West Aloe, LLC
Substance NameAVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active Ingredient Strength20 mg/g; mg/g; mg/g; mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65008-004-08

227 g in 1 TUBE (65008-004-08)
Marketing Start Date2015-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65008-004-08 [65008000408]

Key West Tan SPF15 LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-02-26

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE50 mg/g

OpenFDA Data

SPL SET ID:ffc74655-dae4-43e8-adee-f88a71eebb9d
Manufacturer
UNII

NDC Crossover Matching brand name "Key West Tan SPF15" or generic name "Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene"

NDCBrand NameGeneric Name
65008-004Key West Tan SPF15Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene
65008-003Sunsorb SPF30Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene
10755-030tourist spf30Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene
10755-015traveler spf15Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene

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