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 ID58443-0035_7d786d5e-388c-daba-e053-2991aa0ab629
NDC58443-0035
Product TypeHuman Otc Drug
Proprietary NameAustralian Gold Broad Spectrum SPF 8
Generic NameAvobenzone, Octisalate, Octocrylene, And Oxybenzone
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2013-10-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NamePrime Enterprises, Inc.
Substance NameAVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active Ingredient Strength10 mg/mL; mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58443-0035-4

237 mL in 1 BOTTLE, WITH APPLICATOR (58443-0035-4)
Marketing Start Date2013-10-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58443-0035-4 [58443003504]

Australian Gold Broad Spectrum SPF 8 LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-10-14

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE9.9 mg/mL

OpenFDA Data

SPL SET ID:2324466d-5ea7-49ca-b264-2fd3fcdc07df
Manufacturer
UNII
UPC Code
  • 0054402250488
  • NDC Crossover Matching brand name "Australian Gold Broad Spectrum SPF 8" or generic name "Avobenzone, Octisalate, Octocrylene, And Oxybenzone"

    NDCBrand NameGeneric Name
    13630-0065Australian Gold Broad Spectrum SPF 8Australian Gold Broad Spectrum SPF 8
    13630-0020Australian Gold Broad Spectrum SPF 8Australian Gold Broad Spectrum SPF 8
    58443-0023Australian Gold Broad Spectrum SPF 8Australian Gold Broad Spectrum SPF 8
    58443-0074Australian Gold BROAD SPECTRUM SPF 8Australian Gold BROAD SPECTRUM SPF 8
    58443-0015Australian Gold Broad Spectrum SPF 8Australian Gold Broad Spectrum SPF 8
    58443-0029Australian Gold Broad Spectrum SPF 8Australian Gold Broad Spectrum SPF 8
    58443-0075Australian Gold BROAD SPECTRUM SPF 8Australian Gold BROAD SPECTRUM SPF 8
    58443-0026Australian Gold Broad Spectrum SPF 8Australian Gold Broad Spectrum SPF 8
    58443-0016Australian GoldAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    58443-0024Australian GoldAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    58443-0027Australian GoldAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    58443-0028Australian GoldAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    58443-0035Australian GoldAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    58443-0037Australian GoldAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    49527-709CLINIQUEAVOBENZONE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE
    11523-7053Coppertone Sport Sunscreen Lip Balmavobenzone, octisalate, octocrylene, and oxybenzone
    13537-153ESIKAAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    13537-995LBEL LEDERM 35 plus JOUR Facial against first signs of agingAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    14141-995LBEL LEDERM 35 plus JOUR Facial against first signs of agingAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    13537-444LBEL LEDERM 35plus JourAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    13537-445LBEL LEDERM 35plus JourAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    14783-014LBEL LEDERM 35plus JourAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    14783-015LBEL LEDERM 35plus JourAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    13537-994LBEL LEDERM 45 plus JOUR Facial against noticeable signs of agingAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    14141-994LBEL LEDERM 45 plus JOUR Facial against noticeable signs of agingAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    14783-991LBEL LEDERM 45 plus JOUR Facial against noticeable signs of agingAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    13537-446LBEL LEDERM 45plus JourAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    13537-447LBEL LEDERM 45plus JourAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    14783-016LBEL LEDERM 45plus JourAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    14783-017LBEL LEDERM 45plus JourAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    13537-754LBEL LEDERM 55 plus JOUR Facial against advanced signs of agingAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    14141-754LBEL LEDERM 55 plus JOUR Facial against advanced signs of agingAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    13537-448LBEL LEDERM 55plus JourAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    14783-019LBEL LEDERM 55plus JourAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    14783-803LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15Avobenzone, Octisalate, Octocrylene, and Oxybenzone
    14783-804LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15Avobenzone, Octisalate, Octocrylene, and Oxybenzone
    14141-136LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin typesAVOBENZONE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE
    14783-119LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin typesAVOBENZONE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE
    58232-0753Lubriderm Daily MoistureAvobenzone, Octisalate, Octocrylene, and Oxybenzone
    10812-979Neutrogena Oil Free Moisture Broad Spectrum SPF15Avobenzone, Octisalate, Octocrylene, and Oxybenzone
    13630-0075SolMateAvobenzone, Octisalate, Octocrylene, and Oxybenzone

    Trademark Results [Australian Gold]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    79070951 3781380 Dead/Cancelled
    Lactos Pty Ltd
    2009-04-07
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    79020018 3472377 Dead/Cancelled
    Lactos Pty Ltd
    2005-08-25
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    77949614 3959245 Live/Registered
    Australian Gold, LLC
    2010-03-03
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    77178877 3533030 Live/Registered
    AUSTRALIAN GOLD, LLC
    2007-05-11
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    75044705 2062813 Live/Registered
    AUSTRALIAN GOLD, LLC
    1996-01-17
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    74800625 not registered Dead/Abandoned
    CROCODILE MARKETING LTD.
    1989-09-12
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    74292236 1807592 Dead/Cancelled
    Australian Gold, Inc.
    1992-07-06
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    74062677 not registered Dead/Abandoned
    American Tanning Systems, Inc.
    1990-05-25
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    73824907 not registered Dead/Abandoned
    CROCODILE MARKETING LTD.
    1989-09-12
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    73799225 1637325 Live/Registered
    AMERICAN TANNING SYSTEMS, INC.
    1989-05-11
    AUSTRALIAN GOLD
    AUSTRALIAN GOLD
    73075785 1046627 Live/Registered
    DAGAR PRODUCTS, INC.
    1976-01-30

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