AUSTRALIAN GOLD BOTANICAL SUNSCREEN TINTED FACE 50 FOR MEDIUM TO TAN SKIN TONES- 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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Botanical Sunscreen TInted Face 50 BB Cream for Medium to Tan Skin Tones

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

Cyclopentasiloxane, Water/Aqua/Eau, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Polymethylsilsesquioxane, PEG-10 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Porphyra Umbilicalis Extract, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Dimethicone Crosspolymer, Stearic Acid, Caprylyl Glycol, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Squalane, Panthenol, Disodium EDTA, Triethoxycaprylylsilane, Alumina, Phenoxyethanol, Iron Oxides (CI 77492, CI 77491, CI 77499)

Other information

  • Protect this product from excessive heat and direct sun

Questions or comments?

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

BOTANICAL SUNSCREEN TINTED FACE 50 BB CREAM FOR MEDIUM TO TAN SKIN TONES

Principal Display Label

AUSTRALIAN GOLD BOTANICAL  SUNSCREEN TINTED FACE 50 FOR MEDIUM TO TAN SKIN TONES
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0271
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE43.6 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE43.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
SQUALANE (UNII: GW89575KF9)  
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)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorbrown (Nude) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0271-389 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0271) , manufacture(58443-0271) , label(58443-0271) , analysis(58443-0271)

Revised: 8/2019
Document Id: 9147ae95-20f3-217c-e053-2995a90a4e93
Set id: 9147baed-3bcc-fc1c-e053-2a95a90a28c6
Version: 1
Effective Time: 20190830
 
Prime Enterprises Inc.