Label: AUSTRALIAN GOLD BOTANICALS SUNSCREEN 70 MINERALS- titanium dioxide, zinc oxide lotion
- NDC Code(s): 58443-0624-4
- 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 July 17, 2023
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- 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 in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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
-
Inactive Ingredients
Alumina, Butyrospermum Parkii (Shea) Butter, C13-15 Alkane, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disterdimonium Hectorite, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Fragrance (Parfum), Glycerin, Hexyl Laurate, Isododecane, Isohexadecane, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Porphyra Umbilicalis Extract, Silica, Squalane, Stearic Acid, Tocopheryl Acetate, Water/Aqua/Eau
- Other information
- Questions or comments?
- Botanical Sunscreen 70 Broad Spectrum SPF 70 Mineral Lotion
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD BOTANICALS SUNSCREEN 70 MINERALS
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0624 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 43.82 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 49.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) C13-15 ALKANE (UNII: 114P5I43UJ) PHENOXYETHANOL (UNII: HIE492ZZ3T) ISOHEXADECANE (UNII: 918X1OUF1E) ISODODECANE (UNII: A8289P68Y2) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PANTHENOL (UNII: WV9CM0O67Z) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SQUALANE (UNII: GW89575KF9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) STEARIC ACID (UNII: 4ELV7Z65AP) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) EDETATE DISODIUM (UNII: 7FLD91C86K) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) HEXYL LAURATE (UNII: 4CG9F9W01Q) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 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:58443-0624-4 147 mL in 1 TUBE; Type 0: Not a Combination Product 07/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 07/17/2023 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0624) , manufacture(58443-0624) , label(58443-0624) , analysis(58443-0624)