AUSTRALIAN GOLD BOTANICAL SUNSCREEN TINTED FACE 50 FOR MEDIUM TO TAN SKIN TONES- titanium dioxide, zinc oxide lotion

Australian Gold Botanical by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

AUSTRALIAN GOLD BOTANICAL  SUNSCREEN TINTED FACE 50 FOR MEDIUM TO TAN SKIN TONES
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0271
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	43.6 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	43.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	brown (Nude)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0271-3	89 mL in 1 TUBE; Type 0: Not a Combination Product	08/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/30/2019

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0271) , manufacture(58443-0271) , label(58443-0271) , analysis(58443-0271)