NDC 58443-0035

Australian Gold Broad Spectrum SPF 8

Avobenzone, Octisalate, Octocrylene, And Oxybenzone

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

• Product ID: 58443-0035_7d786d5e-388c-daba-e053-2991aa0ab629
• NDC: 58443-0035
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold Broad Spectrum SPF 8
• Generic Name: Avobenzone, Octisalate, Octocrylene, And Oxybenzone
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-10-14
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises, Inc.
• Substance Name: AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
• Active Ingredient Strength: 10 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0035-4

237 mL in 1 BOTTLE, WITH APPLICATOR (58443-0035-4)

• Marketing Start Date: 2013-10-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0035-4 [58443003504]

Australian Gold Broad Spectrum SPF 8 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-10-14

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	9.9 mg/mL

OpenFDA Data

• SPL SET ID: 2324466d-5ea7-49ca-b264-2fd3fcdc07df
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 5A68WGF6WM
• UPC Code:
  • 0054402250488

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

NDC	Brand Name	Generic Name
13630-0065	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
13630-0020	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0023	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
58443-0015	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0029	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
58443-0026	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0016	Australian Gold	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
58443-0024	Australian Gold	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
58443-0027	Australian Gold	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
58443-0028	Australian Gold	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
58443-0035	Australian Gold	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
58443-0037	Australian Gold	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
49527-709	CLINIQUE	AVOBENZONE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE
11523-7053	Coppertone Sport Sunscreen Lip Balm	avobenzone, octisalate, octocrylene, and oxybenzone
13537-153	ESIKA	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
13537-995	LBEL LEDERM 35 plus JOUR Facial against first signs of aging	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14141-995	LBEL LEDERM 35 plus JOUR Facial against first signs of aging	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
13537-444	LBEL LEDERM 35plus Jour	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
13537-445	LBEL LEDERM 35plus Jour	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14783-014	LBEL LEDERM 35plus Jour	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14783-015	LBEL LEDERM 35plus Jour	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
13537-994	LBEL LEDERM 45 plus JOUR Facial against noticeable signs of aging	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14141-994	LBEL LEDERM 45 plus JOUR Facial against noticeable signs of aging	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14783-991	LBEL LEDERM 45 plus JOUR Facial against noticeable signs of aging	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
13537-446	LBEL LEDERM 45plus Jour	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
13537-447	LBEL LEDERM 45plus Jour	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14783-016	LBEL LEDERM 45plus Jour	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14783-017	LBEL LEDERM 45plus Jour	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
13537-754	LBEL LEDERM 55 plus JOUR Facial against advanced signs of aging	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14141-754	LBEL LEDERM 55 plus JOUR Facial against advanced signs of aging	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
13537-448	LBEL LEDERM 55plus Jour	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14783-019	LBEL LEDERM 55plus Jour	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14783-803	LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14783-804	LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
14141-136	LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin types	AVOBENZONE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE
14783-119	LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin types	AVOBENZONE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE
58232-0753	Lubriderm Daily Moisture	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
10812-979	Neutrogena Oil Free Moisture Broad Spectrum SPF15	Avobenzone, Octisalate, Octocrylene, and Oxybenzone
13630-0075	SolMate	Avobenzone, Octisalate, Octocrylene, and Oxybenzone