FDA Label for Surfersskin Sunscreen Zinc

View Indications, Usage & Precautions

Surfersskin Sunscreen Zinc Product Label

The following document was submitted to the FDA by the labeler of this product Skin Alive, Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients

Octinoxate 7.5%

Titanium Dioxide 2.35%

Zinc Oxide 4.2%


Otc - Purpose



Purpose

Sunscreen


Indications & Usage



Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

Provides high protection against sunburn

Regains SPF after 80 minutes of sweating.


Warnings



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.



Otc - When Using



When using this product

Keep out of eyes. Rinse with water to remove.


Otc - Stop Use



Stop use and ask a doctor

if irritation occurs or rash develops and lasts.


Otc - Keep Out Of Reach Of Children



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 Ingredient



Inactive Ingredients

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


Description



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)


Package Label.Principal Display Panel



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


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