NDC 11523-7290

Coppertone waterBABIES Pure and Simple SPF 50

Octinoxate, Octisalate, And Zinc Oxide

Coppertone waterBABIES 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; Octinoxate; Octisalate.

Product ID11523-7290_5420de56-dfeb-74dd-e054-00144ff8d46c
NDC11523-7290
Product TypeHuman Otc Drug
Proprietary NameCoppertone waterBABIES Pure and Simple SPF 50
Generic NameOctinoxate, Octisalate, And Zinc Oxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date1999-05-21
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameBayer Healthcare LLC.
Substance NameZINC OXIDE; OCTINOXATE; OCTISALATE
Active Ingredient Strength165 mg/mL; mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 11523-7290-3

177 mL in 1 BOTTLE, PLASTIC (11523-7290-3)
Marketing Start Date1999-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11523-7290-2 [11523729002]

Coppertone waterBABIES Pure and Simple SPF 50 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-05-21
Marketing End Date2019-08-01

NDC 11523-7290-3 [11523729003]

Coppertone waterBABIES Pure and Simple SPF 50 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-05-21
Marketing End Date2019-08-01

NDC 11523-7290-1 [11523729001]

Coppertone waterBABIES Pure and Simple SPF 50 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-05-21
Marketing End Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE164.72 mg/mL

OpenFDA Data

SPL SET ID:ff187b56-b392-40a7-9135-4e37203f9e71
Manufacturer
UNII
UPC Code
  • 0041100001771
  • NDC Crossover Matching brand name "Coppertone waterBABIES Pure and Simple SPF 50" or generic name "Octinoxate, Octisalate, And Zinc Oxide"

    NDCBrand NameGeneric Name
    11523-7435Coppertone Waterbabies Pure and Simple SPF 50Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
    59062-1207BabyGanics SunscreenOCTINOXATE, OCTISALATE, and ZINC OXIDE
    59062-1210BabyGanics SunscreenOCTINOXATE, OCTISALATE, and ZINC OXIDE
    59062-1238BabyGanics SunscreenOCTINOXATE, OCTISALATE, and ZINC OXIDE
    59062-1247BabyGanics SunscreenOCTINOXATE, OCTISALATE, and ZINC OXIDE
    11523-7301Coppertone KidsOctinoxate, Octisalate, and Zinc Oxide
    11523-7300Coppertone Sensitive SkinOctinoxate, Octisalate, and Zinc Oxide
    11523-7303Coppertone Sensitive SkinOctinoxate, octisalate, and zinc oxide
    11523-7290Coppertone waterBABIES Pure and Simpleoctinoxate, octisalate, and zinc oxide
    70605-029Principal Secret Reclaim Botanical (with SP) Radiant Recovery Day Broad Spectrum SPF 15Octinoxate, Octisalate, and Zinc Oxide
    46783-223Prismplus Broad-Spectrum Sunscreen SPF 43OCTINOXATE, OCTISALATE, and ZINC OXIDE
    58443-0175SolScentsOctinoxate, Octisalate, and Zinc Oxide
    69926-004Too Cool For SchoolOctinoxate, Octisalate, and Zinc Oxide

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