NDC 11523-7464

Coppertone Pure and Simple Baby SPF 50

Octinoxate, Octocrylene, Zinc Oxide

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

Product ID11523-7464_90772474-19e8-4bf9-e053-2995a90a8522
NDC11523-7464
Product TypeHuman Otc Drug
Proprietary NameCoppertone Pure and Simple Baby SPF 50
Generic NameOctinoxate, Octocrylene, Zinc Oxide
Dosage FormStick
Route of AdministrationTOPICAL
Marketing Start Date2018-11-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameBayer HealthCare LLC.
Substance NameOCTOCRYLENE; ZINC OXIDE; OCTINOXATE
Active Ingredient Strength100 mg/g; mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 11523-7464-1

13.9 g in 1 BLISTER PACK (11523-7464-1)
Marketing Start Date2018-11-01
Marketing End Date2021-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11523-7464-1 [11523746401]

Coppertone Pure and Simple Baby SPF 50 STICK
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
OCTOCRYLENE100 mg/g

OpenFDA Data

SPL SET ID:90772474-19e7-4bf9-e053-2995a90a8522
Manufacturer
UNII
UPC Code
  • 0041100006196
  • NDC Crossover Matching brand name "Coppertone Pure and Simple Baby SPF 50" or generic name "Octinoxate, Octocrylene, Zinc Oxide"

    NDCBrand NameGeneric Name
    11523-7441Coppertone Pure and Simple Baby SPF 50zinc oxide
    11523-7464Coppertone Pure and Simple Baby SPF 50octinoxate, octocrylene, zinc oxide
    11523-7475Coppertone Pure and Simple Baby SPF 50zinc oxide
    11523-7401Coppertone Water BabiesOctinoxate, Octocrylene, Zinc Oxide
    69039-208SPF 30 Signature High Performance SunscreenOCTINOXATE, OCTOCRYLENE, ZINC OXIDE
    58930-018Supreme ShieldOctinoxate, Octocrylene, Zinc Oxide
    58930-019Supreme ShieldOctinoxate, Octocrylene, Zinc Oxide
    58930-020Supreme ShieldOctinoxate, Octocrylene, Zinc Oxide

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