NDC 11523-7419

Coppertone Water Babies SPF 50

Avobenzone, Homosalate, Octisalate, And Octocrylene

Coppertone Water Babies 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 Avobenzone; Octisalate; Homosalate; Octocrylene.

Product ID11523-7419_5de442f1-fc7e-d030-e053-2a91aa0a30fc
NDC11523-7419
Product TypeHuman Otc Drug
Proprietary NameCoppertone Water Babies SPF 50
Generic NameAvobenzone, Homosalate, Octisalate, 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 NameAVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE
Active Ingredient Strength31 mg/mL; mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 11523-7419-1

237 mL in 1 BOTTLE, PLASTIC (11523-7419-1)
Marketing Start Date2017-11-01
Marketing End Date2021-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11523-7419-1 [11523741901]

Coppertone Water Babies SPF 50 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-11-01
Marketing End Date2021-09-01

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE30.8 mg/mL

OpenFDA Data

SPL SET ID:5de442f1-fc7d-d030-e053-2a91aa0a30fc
Manufacturer
UNII

NDC Crossover Matching brand name "Coppertone Water Babies SPF 50" or generic name "Avobenzone, Homosalate, Octisalate, And Octocrylene"

NDCBrand NameGeneric Name
11523-7419Coppertone Water Babies SPF 50Avobenzone, Homosalate, Octisalate, and Octocrylene
11523-7207Coppertone Water Babies SPF 50Coppertone Water Babies SPF 50
13630-0094Aloe Upavobenzone, homosalate, octisalate, and octocrylene
13630-0097Aloe Upavobenzone, homosalate, octisalate, and octocrylene
13630-0098Aloe Upavobenzone, homosalate, octisalate, and octocrylene
13630-0157Aloe Upavobenzone, homosalate, octisalate, and octocrylene
13630-0224Aloe Upavobenzone, homosalate, octisalate, and octocrylene
13630-0225Aloe Upavobenzone, homosalate, octisalate, and octocrylene
43419-580Amorepacific Natural ProtectorAVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
13630-0078California TanAvobenzone, Homosalate, Octisalate, and Octocrylene
13630-0079California TanAvobenzone, Homosalate, Octisalate, and Octocrylene
11523-0461Coppertone SportAvobenzone, Homosalate, Octisalate, and Octocrylene
11523-7054Coppertone ultraGUARDAvobenzone, Homosalate, Octisalate, and Octocrylene
11523-7433Coppertone Waterbabies Pure and Simple Light SPF 50Avobenzone, Homosalate, Octisalate, and Octocrylene
11559-055DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
13630-0123Florida Salt ScrubsAvobenzone, Homosalate, Octisalate, and Octocrylene
11090-099LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 SunscreenAvobenzone, Homosalate, Octisalate, and Octocrylene
13630-0103Miami Beachavobenzone, homosalate, octisalate, and octocrylene
13630-0104Miami Beachavobenzone, homosalate, octisalate, and octocrylene
13734-158NARS RADIANCE PRIMERAVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
10812-537Neutrogena Triple Age Repair MoisturizerAvobenzone, Homosalate, Octisalate, and Octocrylene
37000-752Olay Complete All DayAvobenzone, Homosalate, Octisalate, and Octocrylene
37000-352Olay Total Effects Anti-Aging MoisturizerAvobenzone, Homosalate, Octisalate, and Octocrylene
37000-292Olay Total Effects Feather Weight MoisturizerAvobenzone, Homosalate, Octisalate, and Octocrylene
37000-260Olay Total Effects Moisturizer Plus Serum Duo Fragrance FreeAvobenzone, Homosalate, Octisalate, and Octocrylene
13630-0213Ulta BeautyAvobenzone, Homosalate, Octisalate, and Octocrylene
13630-0214Ulta BeautyAvobenzone, Homosalate, Octisalate, and Octocrylene
13630-0216Ulta BeautyAvobenzone, Homosalate, Octisalate, and Octocrylene
42851-055ZO SKIN HEALTH OCLIPSE SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
42851-054ZO SKIN HEALTH OCLIPSE SUN SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE PLUS BODY WATER/PERSPIRATION RESISTANT (80 minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.