NDC 63550-850

SUN DEFENSE SPF 15

Avobenzone Homosalate Octisalate Oxybenzone

SUN DEFENSE SPF 15 is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Kamins Dermatologics Inc.. The primary component is Avobenzone; Homosalate; Octisalate; Oxybenzone.

• Product ID: 63550-850_3f806047-1d73-45c8-870a-3c7cdfcd08b8
• NDC: 63550-850
• Product Type: Human Otc Drug
• Proprietary Name: SUN DEFENSE SPF 15
• Generic Name: Avobenzone Homosalate Octisalate Oxybenzone
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-09-02
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Kamins Dermatologics Inc.
• Substance Name: AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE
• Active Ingredient Strength: 30 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 63550-850-12

150 mL in 1 BOX (63550-850-12)

• Marketing Start Date: 2011-09-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63550-850-12 [63550085012]

SUN DEFENSE SPF 15 SPRAY

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-09-02
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	30 mg/mL

OpenFDA Data

• SPL SET ID: 3bcbedde-42f5-40d6-99fd-7e4c88a4975b
• Manufacturer:
  • Kamins Dermatologics Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 4X49Y0596W
  • V06SV4M95S

NDC Crossover Matching brand name "SUN DEFENSE SPF 15" or generic name "Avobenzone Homosalate Octisalate Oxybenzone"

NDC	Brand Name	Generic Name
63550-850	SUN DEFENSE SPF 15	AVOBENZONE HOMOSALATE OCTISALATE OXYBENZONE
63550-810	SUNBAR SPF 15	AVOBENZONE HOMOSALATE OCTISALATE OXYBENZONE