NDC 21839-450

COOLA Classic Body Sunscreen Guava Mango SPF 50

Avobenzone,homosalate, Octisalate,octocrylene

COOLA Classic Body Sunscreen Guava Mango SPF 50 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Gordon Laboratories, Inc.. The primary component is Avobenzone; Octisalate; Octocrylene; Homosalate.

Product ID21839-450_9aa24411-fdae-c256-e053-2a95a90a3649
NDC21839-450
Product TypeHuman Otc Drug
Proprietary NameCOOLA Classic Body Sunscreen Guava Mango SPF 50
Generic NameAvobenzone,homosalate, Octisalate,octocrylene
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2019-01-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameGordon Laboratories, Inc.
Substance NameAVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE
Active Ingredient Strength18 mg/mL; mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 21839-450-02

1 TUBE in 1 CARTON (21839-450-02) > 148 mL in 1 TUBE (21839-450-01)
Marketing Start Date2019-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21839-450-02 [21839045002]

COOLA Classic Body Sunscreen Guava Mango SPF 50 LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-31

NDC 21839-450-01 [21839045001]

COOLA Classic Body Sunscreen Guava Mango SPF 50 LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-31

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE17.5 mg/mL

OpenFDA Data

SPL SET ID:9aa24411-fdad-c256-e053-2a95a90a3649
Manufacturer
UNII
UPC Code
  • 0857724008252
  • NDC Crossover Matching brand name "COOLA Classic Body Sunscreen Guava Mango SPF 50" or generic name "Avobenzone,homosalate, Octisalate,octocrylene"

    NDCBrand NameGeneric Name
    21839-430COOLA Classic Body Sunscreen Fragrance-FreeAVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE
    21839-450COOLA Classic Body Sunscreen Guava MangoAVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE
    21839-620COOLA Full Spectrum 360 Sun Silk DropsAVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE
    21839-590COOLA Refreshing Water Mist SunscreenAVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE

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