Australian Gold Botanical Sunscreen 70 Mineral Lotion

Australian Gold by

Drug Labeling and Warnings

Australian Gold by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AUSTRALIAN GOLD BOTANICALS SUNSCREEN 70 MINERALS- 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 Sunscreen 70 Mineral Lotion

Active Ingredients

Titanium Dioxide 4.4%

Zinc Oxide 5%

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 useon 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, 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

• Protect this product from excessive heat and direct sun
• May stain some fabrics or surfaces

Questions or comments?

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

Botanical Sunscreen 70 Broad Spectrum SPF 70 Mineral Lotion

AUSTRALIAN GOLD  BOTANICALS SUNSCREEN 70 MINERALS
titanium dioxide, zinc oxide lotion

Product 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)

Revised: 7/2023

Document Id: 00b5909d-4964-86cc-e063-6394a90ab2fa

34390-5

Set id: 00b5ac56-820a-acb7-e063-6394a90abdfa

Version: 1

Effective Time: 20230717