Label: AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 58443-0551-4
- 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 April 29, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
-
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
Cyclopentasiloxane, Water, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Polymethylsilsesquioxane, PEG-10 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Dimethicone Crosspolymer, Fragrance, Stearic Acid, Phenoxyethanol, Alumina, Caprylyl Glycol, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Panthenol, Squalane, Disodium EDTA, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Porphyra Umbilicalis Extract, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract
- Other Information
- Questions or Comments?
- Australian Gold Botanical Sunscreen Broad Spectrum SPF 50
-
INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0551 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 41.2 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 41.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) KAKADU PLUM (UNII: 0ZQ1D2FDLI) 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) PANTHENOL (UNII: WV9CM0O67Z) FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALUMINUM OXIDE (UNII: LMI26O6933) 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:58443-0551-4 147 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/04/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/04/2022 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0551) , manufacture(58443-0551) , label(58443-0551) , analysis(58443-0551)
