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NDC 13630-0261-04 Australian Gold 25.2; 84; 42; 42 g/mL; g/mL; g/mL; g/mL Details

Australian Gold 25.2; 84; 42; 42 g/mL; g/mL; g/mL; g/mL

Australian Gold is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Prime Packaging, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	13630-0261
Product ID	13630-0261_ed86d0bb-9bf2-0cd5-e053-2995a90a45c3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Australian Gold
Proprietary Name Suffix	Broad Spectrum SPF 50
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	25.2; 84; 42; 42
Active Ingredient Units	g/mL; g/mL; g/mL; g/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Prime Packaging, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M020
Listing Certified Through	2024-12-31

Package

Package Images

NDC 13630-0261-04 (13630026104)

Pricing Information	N/A
NDC Package Code	13630-0261-4
Billing NDC	13630026104
Package	202 mL in 1 CAN (13630-0261-4)
Marketing Start Date	2019-10-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ed86e27e-759b-1fa1-e053-2995a90a2cb8 Details

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 (50ºC).

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 into 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 before use.

Inactive ingredients

SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Polyester-8, Helianthus Annuus (Sunflower) seed Oil, Tocopheryl Acetate, Menthol, Aloe Barbadensis Leaf Extract, Melaleuca Alternolia (Tea Tree) Leaf Oil

Other information

• Protect this product from excessive heat and direct sun

• May stain some fabrics or surfaces

Questions or comments?

Call toll free 866-960-1568

Australian Gold Sunscreen Broad Spectrum SPF 50 Continuous Spray

INGREDIENTS AND APPEARANCE

AUSTRALIAN GOLD BROAD SPECTRUM SPF 50

avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0261
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.2 g in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	84 g in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42 g in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	42 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ALCOHOL (UNII: 3K9958V90M)
VINYL ACETATE (UNII: L9MK238N77)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
MENTHOL (UNII: L7T10EIP3A)
TEA TREE OIL (UNII: VIF565UC2G)

Product Characteristics
Color	yellow (very Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0261-4	202 mL in 1 CAN; Type 0: Not a Combination Product	10/23/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/23/2019

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0261) , analysis(13630-0261)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0261) , pack(13630-0261)

Revised: 11/2022

Document Id: ed86d0bb-9bf2-0cd5-e053-2995a90a45c3

Set id: ed86e27e-759b-1fa1-e053-2995a90a2cb8

Version: 1

Effective Time: 20221115