NDC 11523-7417

Coppertone Tanning Defend and Glow SPF 8

Octinoxate And Octocrylene

Coppertone Tanning Defend and Glow SPF 8 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Octinoxate; Octocrylene.

Product ID11523-7417_5d2f4b7b-f84e-bd9e-e053-2991aa0ab907
NDC11523-7417
Product TypeHuman Otc Drug
Proprietary NameCoppertone Tanning Defend and Glow SPF 8
Generic NameOctinoxate And Octocrylene
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2017-11-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameBayer HealthCare LLC.
Substance NameOCTINOXATE; OCTOCRYLENE
Active Ingredient Strength70 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 11523-7417-1

237 mL in 1 BOTTLE (11523-7417-1)
Marketing Start Date2017-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11523-7417-1 [11523741701]

Coppertone Tanning Defend and Glow SPF 8 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-11-01
Marketing End Date2020-09-01

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE70.175 mg/mL

OpenFDA Data

SPL SET ID:5d2f4b7b-f84d-bd9e-e053-2991aa0ab907
Manufacturer
UNII
UPC Code
  • 0041100081810
  • NDC Crossover Matching brand name "Coppertone Tanning Defend and Glow SPF 8" or generic name "Octinoxate And Octocrylene"

    NDCBrand NameGeneric Name
    11523-7417Coppertone Tanning Defend and Glow SPF 8Octinoxate and Octocrylene
    11523-7094Bain de SoleilOctinoxate and Octocrylene
    13537-012CYZONEOCTINOXATE and OCTOCRYLENE
    13537-013CYZONEOCTINOXATE and OCTOCRYLENE
    13537-014CYZONEOCTINOXATE and OCTOCRYLENE
    13537-015CYZONEOCTINOXATE and OCTOCRYLENE
    62839-0369Nu Skin Sunright Lip Balm Broad Spectrum SPF 15Octinoxate and Octocrylene
    52686-231SHISEIDOOctinoxate and Octocrylene
    52686-230SHISEIDO BENEFIANCE WRINKLERESIST24 DAYOctinoxate and Octocrylene
    52686-228SHISEIDO WHITE LUCENTOctinoxate and Octocrylene
    62499-445SPF 15 Anti-shine moisturizingOCTINOXATE and OCTOCRYLENE

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