NDC 13630-0065

Australian Gold Broad Spectrum SPF 8

Avobenzone, Octocrylene, And Oxybenzone

Australian Gold 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; Octocrylene; Oxybenzone.

• Product ID: 13630-0065_7d661e2c-6d34-35ab-e053-2a91aa0af61f
• NDC: 13630-0065
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold Broad Spectrum SPF 8
• Generic Name: Avobenzone, Octocrylene, And Oxybenzone
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-04-25
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Packaging, Inc.
• Substance Name: AVOBENZONE; OCTOCRYLENE; OXYBENZONE
• Active Ingredient Strength: 8 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 13630-0065-4

177 mL in 1 CAN (13630-0065-4)

• Marketing Start Date: 2012-04-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13630-0065-4 [13630006504]

Australian Gold Broad Spectrum SPF 8 SPRAY

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-04-25

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	8.2 mg/mL

OpenFDA Data

• SPL SET ID: b7b74b6c-cc0a-44f6-b3f3-c34612a169eb
• Manufacturer:
  • Prime Packaging, Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 5A68WGF6WM

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

NDC	Brand Name	Generic Name
13630-0020	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0035	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0074	Australian Gold BROAD SPECTRUM SPF 8	Australian Gold BROAD SPECTRUM SPF 8
58443-0075	Australian Gold BROAD SPECTRUM SPF 8	Australian Gold BROAD SPECTRUM SPF 8
13630-0008	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
13630-0065	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0015	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0021	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0022	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0023	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0026	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0029	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0034	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0220	Australian Gold	Avobenzone, octocrylene, and oxybenzone
58443-0082	California Tan	Avobenzone, Octocrylene, and Oxybenzone
0259-3192	Mederma	AVOBENZONE, OCTOCRYLENE, and OXYBENZONE
73302-200	Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, and OXYBENZONE
73302-205	Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, and OXYBENZONE