SURFERS SKIN SUNSCREEN - octinoxate, oxybenzone, titanium dioxide, zinc oxide cream 
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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Surfers Skin Sunscreen

Active Ingredients

Active Ingredients

Octinoxate 7.5%

Oxybenzone 3.45%

Titanium Dioxide 1%

Zinc Oxide 1.95%

Purpose

Purpose

Sunscreen

Uses

Helps prevent Sunburn

Higher SPF gives more sunburn protection

Provides high protection against sunburn

Retains SPF after 80 minutes of swimming

Warnings

Warnings

For external use only

UV exposure from the sun increases the risk of skin cancer, premature 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

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

Keep out of reach of children

Directions

Apply generously 15 min 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

Aloe Vera Gel, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cyclomethicone, Deionised Water, Fragrance, Glyceryl Monostearate, Phenoxyethanol, Polysorbate 60, PVP?ejcosene, Retinol Palminate, Sorbitan Monostearate, Tocopherol Acetate, UMF 18 Manuka Honey

Surfersskin SPF 30+ Sunscreen, VERY WATER/SWEAT RESISTANT, BROAD SPECTRUM, UVA/UVB PROTECTION. keep your "Skin Alive" with this non greasy sweat resistant formula that won't runinto your eyes and give you up to 80 mins protection in the water.


Made in NZ

Skin alive



Expires:
Lot Number

www.surfersskin.co

DIST. BY: Quiver Dist., Bend Oregon, USA 97701

AS/ANZ STANDARD 2604-1998

4.2 fl oz (125ml)



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

spf 30+

very water/sweat resistant

broad spectrum

UVA/UVB Protection

Surfersskin Sunscreen

Proven in Extreme New Zealand conditions

4.2 fl oz (125ml)

manuka honey UMF 18

CONTAINS NO NANOPARTICLES - AMINOBENZOIC ACID (PABA)-FREE

Surfersskin Sunscreen

Surfersskin Sunscreen

SURFERS SKIN SUNSCREEN 
octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75916-4019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.45 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.95 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HONEY (UNII: Y9H1V576FH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75916-4019-4125 mL in 1 TUBE
2NDC:75916-4019-11 in 1 BOX
240 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/31/2011
Labeler - Skin Alive, Ltd. (593384746)

Revised: 1/2011
Document Id: 1bcab3f2-a9fd-4f3a-8f34-528b3223b54c
Set id: bd17a43b-231b-43b7-b65a-7b71389cb7c3
Version: 2
Effective Time: 20110131
 
Skin Alive, Ltd.