NDC 58443-0313

Austalian Gold Broad Spectrum SPF 15 Sunscreen

Octisalate, Avobenzone, Octocrylene

Austalian Gold Broad Spectrum SPF 15 Sunscreen is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises Inc.. The primary component is Avobenzone; Octocrylene; Octisalate.

Product ID58443-0313_a5151f4f-2674-40fd-e053-2995a90a5d15
NDC58443-0313
Product TypeHuman Otc Drug
Proprietary NameAustalian Gold Broad Spectrum SPF 15 Sunscreen
Generic NameOctisalate, Avobenzone, Octocrylene
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2019-10-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NamePrime Enterprises Inc.
Substance NameAVOBENZONE; OCTOCRYLENE; OCTISALATE
Active Ingredient Strength19 mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 58443-0313-4

237 mL in 1 BOTTLE (58443-0313-4)
Marketing Start Date2019-10-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58443-0313-4 [58443031304]

Austalian Gold Broad Spectrum SPF 15 Sunscreen LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-18

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE19.4 mg/mL

NDC Crossover Matching brand name "Austalian Gold Broad Spectrum SPF 15 Sunscreen" or generic name "Octisalate, Avobenzone, Octocrylene"

NDCBrand NameGeneric Name
59427-702A PERFECT WORLDoctisalate, avobenzone, octocrylene
13630-0184ALOE UPOctisalate, Avobenzone, Octocrylene
58443-0311Austalian GoldOctisalate, Avobenzone, Octocrylene
58443-0313Austalian GoldOctisalate, Avobenzone, Octocrylene
58443-0603Austalian GoldOctisalate, Avobenzone, Octocrylene
49527-759EVEN BETTER SKIN TONE CORRECTING MOSTURIZEROCTISALATE, AVOBENZONE, OCTOCRYLENE

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