SURFERSSKIN SUNSCREEN ZINC - octinoxate, titanium dioxide, zinc oxide stick 
Skin Alive, 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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SurfersSkin Sunscreen Zinc

Active Ingredients

Octinoxate 7.5%

Titanium Dioxide 2.35%

Zinc Oxide 4.2%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

Provides high protection against sunburn

Regains SPF after 80 minutes of sweating.

Warnings

For external use only

UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen.


When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if irritation occurs or rash develops and lasts.

Directions

apply generously 15mins before sun exposure and as needed

Children under 6 months of age: ask a doctor.

Reapply as needed or after towel drying, swimming or sweating.

Inactive Ingredients

Butylated Hydroxytoluene, Castor oil, Fragrance, Hydrogenated castor oil, Iron Oxides, Kaolin, Oleyl-alcohol, paraffin wax, petroleum jelly, sunflower oil, Talc

SurfersSkin SPF 30+ Sunscreen Zinc gives great protection especially in the snow. Apply liberally to face, nose and lips.


To report a serious adverse event, contact 1-800-332-1088

Expires:

Lot Number:

ww.snowskin.co

DIST. BY Quiver Dist, Bend Oregon, USA 97701

Tested on Snowboarders - Not animals

AS/ANZ STANDARD 2604-1998

Net Wt. 0.30oz (8.5g)

SPF 30+

very water / sweat resistant

broad spectrum

UVA/UVB protection



Proven in extreme new zealand conditions

SufersSkin sunscreen Zinc

hands free

Net Wt. 0.30oz (8.5g)

contains no nanoparticles-aminobenzoic acid (PABA) free

SurfersSkin Sunscreen Zinc

Sufersskin Sunscreen Zinc2

SURFERSSKIN SUNSCREEN ZINC 
octinoxate, titanium dioxide, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75916-0636
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.35 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE4.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CASTOR OIL (UNII: D5340Y2I9G)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
IRON (UNII: E1UOL152H7)  
KAOLIN (UNII: 24H4NWX5CO)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75916-0636-11 in 1 BOX
18.5 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/27/2011
Labeler - Skin Alive, Ltd. (593384746)

Revised: 1/2011
Document Id: 94f4872f-0945-4c31-b37a-b786bffbbc94
Set id: 8c39cdf7-6586-4cc3-a7c7-938ae7508142
Version: 1
Effective Time: 20110127
 
Skin Alive, Ltd.