AUSTRALIAN GOLD BOTANICAL SUNSCREEN SPF 50 KIDS BROAD SPECTRUM- titanium dioxide, zinc oxide lotion 
Prime Enterprises Inc.

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.

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Australian Gold Botanical SPF 50 Kids Lotion

Active Ingredients

Titanium Dioxide 4%

Zinc Oxide 4%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only.

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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, Backhousia Citriodora (Lemon Myrtle) Leaf Extract, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Eucalyptus Globulus Leaf Extract, Glycerin, Hexyl Laurate, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Porphyra Umbilicalis Extract, Silica, Squalane, Stearic Acid, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate*, Water (Aqua)

Other Information

  • protect this product from excessive heat and direct sun

Questions or Comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Australian Gold Botanical Sunscreen Broad Spectrum SPF 50 Kids

Principal Display Image

AUSTRALIAN GOLD  BOTANICAL SUNSCREEN SPF 50 KIDS BROAD SPECTRUM
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0252
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE42.2 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE42.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
SQUALANE (UNII: GW89575KF9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SHEA BUTTER (UNII: K49155WL9Y)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0252-4147 mL in 1 TUBE; Type 0: Not a Combination Product11/07/201707/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/07/201707/23/2018
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0252) , manufacture(58443-0252) , label(58443-0252) , analysis(58443-0252)

Revised: 5/2022
Document Id: ded2c79e-1d72-537e-e053-2a95a90a2b99
Set id: 5d678911-a6d4-9403-e053-2a91aa0a3c5c
Version: 3
Effective Time: 20220512
 
Prime Enterprises Inc.