SUNSCREEN SPORT SPF30 PLUS BROAD SPECTRUM- zinc oxide  lotion 
UV Natural International 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.

----------

Zinc oxide 24.8%

Sunscreen

Uses


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 Centre right away.

Directions

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:

Children under 6 months ask your doctor.

protect this product from excessive heat and direct sun

Vitis vinifera (grape) seed oil, Caprilic/capric triglycerides, Slica, Zinc stearate, Macadami ternifolia seed oil, Camellia oleifera leaf extract (green tea), Vitis vinifera (grape) seed extract, Tocopherol, Iron oxides, Lavandula angustifolia (lavender) oil, Fusanus spicatus wood oil (Australian sandalwood), Pogostemon cablin oil (patchouli oil)



SPF30 Sport Label




SUNSCREEN SPORT  SPF30 PLUS BROAD SPECTRUM
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29565-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE32.3 mL  in 130 mL
Inactive Ingredients
Ingredient NameStrength
GRAPE SEED OIL (UNII: 930MLC8XGG)  
TRICAPRIN (UNII: O1PB8EU98M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ZINC STEARATE (UNII: H92E6QA4FV)  
MACADAMIA OIL (UNII: 515610SU8C)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
PATCHOULI OIL (UNII: F3IN55X5PO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29565-400-40130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2006
Labeler - UV Natural International Pty Ltd (751681078)
Registrant - UV Natural International Pty Ltd (751681078)
Establishment
NameAddressID/FEIBusiness Operations
Aloe Vera Industries Pty Ltd758970461manufacture

Revised: 5/2012
Document Id: 0cb2033f-d54f-4b90-9c62-6f64c12eb163
Set id: b199e5cf-9b73-4b48-ae14-6d6d41c7cd03
Version: 1
Effective Time: 20120510
 
UV Natural International Pty Ltd