Label: AUSTRALIAN GOLD FACE STICK SPF 50- avobenzone, homosalate, octisalate, octocrylene stick
- NDC Code(s): 58443-0626-2
- Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 19, 2023
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- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
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Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive Ingredients
Aloe Barbadensis Leaf Extract, Beeswax, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Ozokerite, Phenoxyethanol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, VP/Hexadecene Copolymer, Zinc Oxide
- Other information
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD FACE STICK SPF 50
avobenzone, homosalate, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0626 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 28 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 92 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 46 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 46 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ZINC OXIDE (UNII: SOI2LOH54Z) SHEA BUTTER (UNII: K49155WL9Y) OLIVE OIL (UNII: 6UYK2W1W1E) YELLOW WAX (UNII: 2ZA36H0S2V) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) SUNFLOWER OIL (UNII: 3W1JG795YI) CERESIN (UNII: Q1LS2UJO3A) Product Characteristics Color white (Off-White to Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0626-2 15.27 mL in 1 TUBE; Type 0: Not a Combination Product 07/18/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 07/18/2023 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0626) , pack(58443-0626) , manufacture(58443-0626) , analysis(58443-0626)
