GOLFERSSKIN SUNSCREEN ZINC- octinoxate, titanium dioxide, zinc oxide stick

GolfersSkin Sunscreen Zinc by

Drug Labeling and Warnings

GolfersSkin Sunscreen Zinc by is a Otc medication manufactured, distributed, or labeled by Skin Alive, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Octinoxate 7.5%

Titanium Dioxide 2.35%

Zinc Oxide 4.2%

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.

WHEN USING

When using this product

Keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor

if irritation occurs or rash develops and lasts.

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

Golfersskin 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)

PRINCIPAL DISPLAY PANEL

SPF 30+

very water / sweat resistant

broad spectrum

UVA/UVB protection

Proven in extreme new zealand conditions

GolfersSkin sunscreen Zinc

hands free

Net Wt. 0.30oz (8.5g)

contains no nanoparticles-aminobenzoic acid (PABA) free

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOLFERSSKIN SUNSCREEN ZINC 
octinoxate, titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75916-0635
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.35 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	4.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75916-0635-1	1 in 1 BOX
1		8.5 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/27/2011

Labeler - Skin Alive, Ltd. (593384746)