NDC 11523-7458

Coppertone Pure and Simple SPF 50

Zinc Oxide

Coppertone Pure and Simple SPF 50 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Zinc Oxide.

Product ID11523-7458_8fef7bf4-7607-bfac-e053-2995a90a8dd3
NDC11523-7458
Product TypeHuman Otc Drug
Proprietary NameCoppertone Pure and Simple SPF 50
Generic NameZinc Oxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-11-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameBayer HealthCare LLC.
Substance NameZINC OXIDE
Active Ingredient Strength250 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 11523-7458-1

177 mL in 1 BOTTLE, PLASTIC (11523-7458-1)
Marketing Start Date2018-11-01
Marketing End Date2021-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11523-7458-1 [11523745801]

Coppertone Pure and Simple SPF 50 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01
Marketing End Date2021-09-01

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE250.19 mg/mL

OpenFDA Data

SPL SET ID:8fef7bf4-7606-bfac-e053-2995a90a8dd3
Manufacturer
UNII
UPC Code
  • 0041100579744
  • NDC Crossover Matching brand name "Coppertone Pure and Simple SPF 50" or generic name "Zinc Oxide"

    NDCBrand NameGeneric Name
    11523-7458Coppertone Pure and Simple SPF 50Coppertone Pure and Simple SPF 50
    11523-7477Coppertone Pure and Simple SPF 50Coppertone Pure and Simple SPF 50
    0316-2082Blue Lizard Active SPF 50zinc oxide
    0316-2011Blue Lizard Baby SPF 50zinc oxide
    0316-2012Blue Lizard Kids SPF 50zinc oxide
    0316-2081Blue Lizard Kids SPF 50zinc oxide
    0316-2013Blue Lizard Sensitive SPF 50zinc oxide
    0316-2083Blue Lizard Sensitive SPF 50zinc oxide
    0316-2080Blue Lizard Sport SPF 50zinc oxide
    0132-0194BoudreauxsZinc Oxide
    0132-0323BoudreauxsZinc Oxide
    0132-0324BoudreauxsZinc Oxide
    0132-0333BoudreauxsZinc Oxide
    0132-0334BoudreauxsZinc Oxide
    0132-0325Boudreauxs Rash Kicking KitZinc oxide
    0201-4008CALENDULA DIAPER RASHZINC OXIDE
    0164-2189CALENDULA DIAPER RASH CREAMZINC OXIDE
    0299-4110Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50zinc oxide
    0178-0330DR SMITHS DIAPERZinc Oxide
    0178-0340Dr Smiths Diaper RashZinc Oxide
    0178-0345Dr Smiths Diaper RashZinc Oxide
    0178-0348Dr Smiths Diaper RashZinc Oxide
    0178-0370Dr. Smiths Rash and SkinZinc Oxide
    0363-0402Walgreen Maximum Strength Diaper RashZINC OXIDE
    0363-0994Walgreens 50 Baby Mineral SunscreenZinc Oxide
    0363-0988Walgreens SPF 50 Mineral SunscreenZINC OXIDE
    0363-4008Walgreens SunscreenSPF 45 SPF 45ZINC OXIDE
    0164-2207WHITE MALLOW DIAPER RASH CREAMZINC OXIDE
    0168-0062ZINC OXIDEZINC OXIDE
    0363-1020Zinc OxideZINC OXIDE
    0363-1226Zinc oxideZinc oxide

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