OUTBACK SERIES 2-IN-1 SUNSCREEN- octyl methoxycinnamate,avobenzone and zinc oxide cream 
Elmore Oil Company 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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Active ingrdient

Octyl Methoxycinnamate - 7.5%

 Avobenzone - 1.3%

 Zinc Oxide - 9.5%

Purpose

Sunscreen 30+

Indication and Usage

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.

Dosage and Administration

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 right away.

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 or 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.



Inactive Ingredients

Actilastin 1000, Melaleuca Alternifolia, Eucalyptus Polybractea, Citronella, Leptospermum Petersonii, Vanilla

Keep out of Reach of Children

Keep Out of Reach of Children

Product Label


obc 1 lab

obc 2 lab




OUTBACK SERIES 2-IN-1 SUNSCREEN 
octyl methoxycinnamate,avobenzone and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43979-446
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 Oxide - UNII:SOI2LOH54Z) Zinc Oxide80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)  
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
CITRONELLA OIL (UNII: QYO8Q067D0)  
TEA TREE OIL (UNII: VIF565UC2G)  
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43979-446-013 mL in 1 POUCH
2NDC:43979-446-0375 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2013
Labeler - Elmore Oil Company Pty Ltd (755881968)
Establishment
NameAddressID/FEIBusiness Operations
Elmore Oil Company Pty Ltd755881968manufacture(43979-446) , pack(43979-446) , label(43979-446)

Revised: 6/2013
Document Id: 28745142-046e-4552-bd9b-1653fbb1a647
Set id: b7453351-ac07-443a-bea9-e1cd8dc2ca9b
Version: 1
Effective Time: 20130611
 
Elmore Oil Company Pty Ltd