NDC 13630-0046

Suntone Broad Spectrum SPF 8

Avobenzone, Octisalate, Octocrylene And Oxybenzone

Suntone Broad Spectrum SPF 8 is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Prime Packaging, Inc.. The primary component is Avobenzone; Octisalate; Octocrylene; Oxybenzone.

• Product ID: 13630-0046_7d653822-c8a3-090c-e053-2a91aa0ad1b0
• NDC: 13630-0046
• Product Type: Human Otc Drug
• Proprietary Name: Suntone Broad Spectrum SPF 8
• Generic Name: Avobenzone, Octisalate, Octocrylene And Oxybenzone
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-03-21
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Packaging, Inc.
• Substance Name: AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
• Active Ingredient Strength: 8 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 13630-0046-4

177 mL in 1 CAN (13630-0046-4)

• Marketing Start Date: 2013-03-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13630-0046-4 [13630004604]

Suntone Broad Spectrum SPF 8 SPRAY

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-03-21

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	8.1 mg/mL

OpenFDA Data

• SPL SET ID: 32581872-6960-45d9-a0e0-1291d6a7ebf8
• Manufacturer:
  • Prime Packaging, Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 5A68WGF6WM

NDC Crossover Matching brand name "Suntone Broad Spectrum SPF 8" or generic name "Avobenzone, Octisalate, Octocrylene And Oxybenzone"

NDC	Brand Name	Generic Name
58443-0074	Australian Gold	Avobenzone, Octisalate, Octocrylene and Oxybenzone
58443-0075	Australian Gold	Avobenzone, Octisalate, Octocrylene and Oxybenzone
58443-0078	Australian Gold	Avobenzone, Octisalate, Octocrylene and Oxybenzone
63868-255	Awaken by Quality Choice Long-Lasting Oil-Free Moisturizer Broad Spectrum SPF 15	Avobenzone, Octisalate, Octocrylene and Oxybenzone
70281-339	BullFrog Land Sport SPF 50 Lip Balm	AVOBENZONE, OCTISALATE, OCTOCRYLENE and OXYBENZONE
36800-360	Long-Lasting Oil-Free Moisturizer	Avobenzone, Octisalate, Octocrylene and Oxybenzone
41250-387	Meijer Elements Long-Lasting Oil-Free	Avobenzone, Octisalate, Octocrylene and Oxybenzone
13630-0046	Suntone	Avobenzone, Octisalate, Octocrylene and Oxybenzone
13630-0045	Sunzen	Avobenzone, Octisalate, Octocrylene and Oxybenzone