OUTBACK 2 IN 1 PROTECTION- octinoxate,avobenzone and zinc oxide cream 
Ultra Mix (Aust) Pty Ltd

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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Outback 2 in 1 Protection

Active Ingredients

OCTINOXATE : 7.5 % AVOBENZONE : 1.3% ZINC OXIDE :9.5%

Inactives

TEA TREE OIL

EUCALYPTUS POLYBRACTEA LEAF OIL

CITRONELLA OIL

LEPTOSPERMUM PETERSONII LEAF OIL

VANILLA

ACTILASTIN 1000

Purpose

Sunscreen, helps prevent sunburn.

Directions of Usage

Apply liberally 15 minutes before sun exposure, reapply after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours.

Warnings

For external use only.

When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if a rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact the Poison Control Center  immediately.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 between 10 a.m – 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor

Product Label

sunscreen

OUTBACK 2 IN 1 PROTECTION 
octinoxate,avobenzone and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69594-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE13 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION95 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)  
CITRONELLA OIL (UNII: QYO8Q067D0)  
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69594-005-0175 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/16/2015
Labeler - Ultra Mix (Aust) Pty Ltd (752254649)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Mix (Aust) Pty Ltd752254649manufacture(69594-005) , label(69594-005)

Revised: 2/2015
Document Id: f7473b9a-663a-4b24-b603-69f765faa818
Set id: 95adf725-b16a-4617-bbe3-105b82de3961
Version: 1
Effective Time: 20150216
 
Ultra Mix (Aust) Pty Ltd