NDC 58443-0312

Austalian Gold Broad Spectrum SPF 30 Sunscreen

Octisalate, Avobenzone, Octocrylene, Homosalate

Austalian Gold Broad Spectrum SPF 30 Sunscreen is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises Inc.. The primary component is Octocrylene; Avobenzone; Octisalate; Homosalate.

Product ID58443-0312_a5107610-4caf-261c-e053-2a95a90a937f
NDC58443-0312
Product TypeHuman Otc Drug
Proprietary NameAustalian Gold Broad Spectrum SPF 30 Sunscreen
Generic NameOctisalate, Avobenzone, Octocrylene, Homosalate
Dosage FormSpray
Route of AdministrationTOPICAL
Marketing Start Date2019-10-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NamePrime Enterprises Inc.
Substance NameOCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE
Active Ingredient Strength49 mg/mL; mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 58443-0312-4

237 mL in 1 BOTTLE, SPRAY (58443-0312-4)
Marketing Start Date2019-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58443-0312-4 [58443031204]

Austalian Gold Broad Spectrum SPF 30 Sunscreen SPRAY
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-30

Drug Details

Active Ingredients

IngredientStrength
OCTOCRYLENE48.5 mg/mL

NDC Crossover Matching brand name "Austalian Gold Broad Spectrum SPF 30 Sunscreen" or generic name "Octisalate, Avobenzone, Octocrylene, Homosalate"

NDCBrand NameGeneric Name
58443-0312Austalian GoldOctisalate, Avobenzone, Octocrylene, Homosalate
58443-0321Austalian GoldOctisalate, Avobenzone, Octocrylene, Homosalate
58443-0589Austalian GoldOctisalate, Avobenzone, Octocrylene, Homosalate
58443-0532Australian GoldOctisalate, Avobenzone, Octocrylene, Homosalate
58443-0570Australian GoldOctisalate, Avobenzone, Octocrylene, Homosalate
14222-2250Rodan and Fields Redefine AMOctisalate, Avobenzone, Octocrylene, Homosalate

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