Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 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 use on damaged or broken skin

When using this product keep away from face to avoid breathing it. 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.

Flammable: Avoid fire, flame heat, and smoking. Contents under pressure. Do not puncture or incinerate. Store at temperatures below 120°F (50°C).

Directions

shake well before use
apply liberally 15 minutes before sun exposure and rub into skin
hold container 4 to 6 inches from the skin to apply
do not spray directly onto face. Spray on hands then apply to face
do not apply in windy conditions
use in a well-ventilated area
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 a 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

Eucalyptus Globulus (Eucalyptus) Leaf Extract, Fragrance (Parfum), Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Tocopheryl Acetate, Trimethoxybenzylidene Pentanedione, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, 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 1-885-LIV-GOLD (548-4653)

Botanical Sunscreen 70 Broad Spectrum SPF 70 Natural Spray

Principle Display Label

AUSTRALIAN GOLD BOTANICAL BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0275
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.71 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	85.7 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.85 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	42.85 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
VINYL ACETATE (UNII: L9MK238N77)
DIBUTYL MALEATE (UNII: 4X371TMK9K)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0275-4	177 mL in 1 CAN; Type 0: Not a Combination Product	12/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	12/05/2022

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0275) , analysis(13630-0275)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0275) , pack(13630-0275)

Botanical Sunscreen 70 Natural Spray