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 ID: 11523-7419_5de442f1-fc7e-d030-e053-2a91aa0a30fc
• NDC: 11523-7419
• Product Type: Human Otc Drug
• Proprietary Name: Coppertone Water Babies SPF 50
• Generic Name: Avobenzone, Homosalate, Octisalate, And Octocrylene
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-11-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Bayer HealthCare LLC.
• Substance Name: AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE
• Active Ingredient Strength: 31 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 11523-7419-1

237 mL in 1 BOTTLE, PLASTIC (11523-7419-1)

• Marketing Start Date: 2017-11-01
• Marketing End Date: 2021-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 11523-7419-1 [11523741901]

Coppertone Water Babies SPF 50 LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-11-01
• Marketing End Date: 2021-09-01

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	30.8 mg/mL

OpenFDA Data

• SPL SET ID: 5de442f1-fc7d-d030-e053-2a91aa0a30fc
• Manufacturer:
  • Bayer HealthCare LLC.
• UNII:
  • G63QQF2NOX
  • 4X49Y0596W
  • 5A68WGF6WM
  • V06SV4M95S

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

NDC	Brand Name	Generic Name
11523-7419	Coppertone Water Babies SPF 50	Avobenzone, Homosalate, Octisalate, and Octocrylene
11523-7207	Coppertone Water Babies SPF 50	Coppertone Water Babies SPF 50
13630-0094	Aloe Up	avobenzone, homosalate, octisalate, and octocrylene
13630-0097	Aloe Up	avobenzone, homosalate, octisalate, and octocrylene
13630-0098	Aloe Up	avobenzone, homosalate, octisalate, and octocrylene
13630-0157	Aloe Up	avobenzone, homosalate, octisalate, and octocrylene
13630-0224	Aloe Up	avobenzone, homosalate, octisalate, and octocrylene
13630-0225	Aloe Up	avobenzone, homosalate, octisalate, and octocrylene
43419-580	Amorepacific Natural Protector	AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
13630-0078	California Tan	Avobenzone, Homosalate, Octisalate, and Octocrylene
13630-0079	California Tan	Avobenzone, Homosalate, Octisalate, and Octocrylene
11523-0461	Coppertone Sport	Avobenzone, Homosalate, Octisalate, and Octocrylene
11523-7054	Coppertone ultraGUARD	Avobenzone, Homosalate, Octisalate, and Octocrylene
11523-7433	Coppertone Waterbabies Pure and Simple Light SPF 50	Avobenzone, Homosalate, Octisalate, and Octocrylene
11559-055	DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
13630-0123	Florida Salt Scrubs	Avobenzone, Homosalate, Octisalate, and Octocrylene
11090-099	LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen	Avobenzone, Homosalate, Octisalate, and Octocrylene
13630-0103	Miami Beach	avobenzone, homosalate, octisalate, and octocrylene
13630-0104	Miami Beach	avobenzone, homosalate, octisalate, and octocrylene
13734-158	NARS RADIANCE PRIMER	AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
10812-537	Neutrogena Triple Age Repair Moisturizer	Avobenzone, Homosalate, Octisalate, and Octocrylene
37000-752	Olay Complete All Day	Avobenzone, Homosalate, Octisalate, and Octocrylene
37000-352	Olay Total Effects Anti-Aging Moisturizer	Avobenzone, Homosalate, Octisalate, and Octocrylene
37000-292	Olay Total Effects Feather Weight Moisturizer	Avobenzone, Homosalate, Octisalate, and Octocrylene
37000-260	Olay Total Effects Moisturizer Plus Serum Duo Fragrance Free	Avobenzone, Homosalate, Octisalate, and Octocrylene
13630-0213	Ulta Beauty	Avobenzone, Homosalate, Octisalate, and Octocrylene
13630-0214	Ulta Beauty	Avobenzone, Homosalate, Octisalate, and Octocrylene
13630-0216	Ulta Beauty	Avobenzone, Homosalate, Octisalate, and Octocrylene
42851-055	ZO SKIN HEALTH OCLIPSE SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
42851-054	ZO 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