Label: AUSTALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 58443-0592-3
- 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 November 21, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- Sun Protection Measures Spending time ine the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF valvue of 15 or higher and other sun protecion measures including:
- limit time in the sun, especially from 10am-2pm
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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INACTIVE INGREDIENTS
Alumina, Cyclopentasiloxane, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Glycerin,Hexyl Laurate, Iron Oxides, Panthenol, Peg-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate,Polymethylsilsesquioxane, Porphyra Umbilicalis Extract, Squalane, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water
- Other Information
- Questions or Comments?
- Australian Gold Botanical Sunscreen Broad Spectrum SPF 50
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INGREDIENTS AND APPEARANCE
AUSTALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0592 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 42.16 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 42.16 g in 1 mL Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) PANTHENOL (UNII: WV9CM0O67Z) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALUMINUM OXIDE (UNII: LMI26O6933) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) STEARIC ACID (UNII: 4ELV7Z65AP) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SQUALANE (UNII: GW89575KF9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) SHEA BUTTER (UNII: K49155WL9Y) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HEXYL LAURATE (UNII: 4CG9F9W01Q) Product Characteristics Color white (Off White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0592-3 88 mL in 1 TUBE; Type 0: Not a Combination Product 10/13/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/13/2016 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0592) , manufacture(58443-0592) , label(58443-0592) , analysis(58443-0592)
