NDC 58443-0321

Austalian Gold Broad Spectrum SPF 50 Sunscreen

Octisalate, Avobenzone, Octocrylene, Homosalate

Austalian Gold Broad Spectrum SPF 50 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 ID58443-0321_a5644622-2a4a-bfdc-e053-2995a90abd1e
NDC58443-0321
Product TypeHuman Otc Drug
Proprietary NameAustalian Gold Broad Spectrum SPF 50 Sunscreen
Generic NameOctisalate, Avobenzone, Octocrylene, Homosalate
Dosage FormSpray
Route of AdministrationTOPICAL
Marketing Start Date2017-10-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NamePrime Enterprises Inc.
Substance NameOCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE
Active Ingredient Strength27 mg/mL; mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 58443-0321-4

237 mL in 1 BOTTLE, SPRAY (58443-0321-4)
Marketing Start Date2017-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58443-0321-4 [58443032104]

Austalian Gold Broad Spectrum SPF 50 Sunscreen SPRAY
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-02

Drug Details

Active Ingredients

IngredientStrength
OCTOCRYLENE27.2 mg/mL

NDC Crossover Matching brand name "Austalian Gold Broad Spectrum SPF 50 Sunscreen" or generic name "Octisalate, Avobenzone, Octocrylene, Homosalate"

NDCBrand NameGeneric Name
58443-0319Austalian Gold Broad Spectrum SPF 50 SunscreenAustalian Gold Broad Spectrum SPF 50 Sunscreen
58443-0315Austalian Gold Broad Spectrum SPF 50 SunscreenAustalian Gold Broad Spectrum SPF 50 Sunscreen
58443-0316Austalian Gold Broad Spectrum SPF 50 SunscreenAustalian Gold Broad Spectrum SPF 50 Sunscreen
58443-0317Austalian Gold Broad Spectrum SPF 50 SunscreenAustalian Gold Broad Spectrum SPF 50 Sunscreen
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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