GOLFERSSKIN FACE SUNSCREEN- octocrylene, titanium dioxide, zinc oxide stick

GolfersSkin Face Sunscreen by

Drug Labeling and Warnings

GolfersSkin Face Sunscreen 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

Octocrylene 6.0%

Titanium Dioxide 3.30%

Zinc Oxide 14.25%

PURPOSE

Purpose

Sunscreen

INACTIVE INGREDIENT

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 ad 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

Alumina, Aluminum Stearate, Avocado Oil, Beeswax, C12-15 Alkyl Bezoate, Candellia Wax, Capryllic/capric Triglyceride, Cydomethicone, Fragrance, Hydrogenerated Castor Wax, Isohexadecane, Isopropyl Myristate, Isosteric Acid, Lanolin Anhydrous, Microwax, Polyhidroxystearic Acid, Polyhydroxystearic Acid, PPG-3 Benzyl Ether Myristate, Triethylhexanoin.

DESCRIPTION

New "hands-free" SPF 30+ from GOLFERS SKIN, the ultimate face stick sunscreen. The quick no mess sturdy applicator delivers without leaving your hands greasy. THE HANDS-FREE FACE STICK PROVIDES VERY WATER/SWEAT RESISTANT, BROAD SPECTRUM UVA/UVB PROTECTION. Its texture is made up of a new resistant formula that won't run into your eyes.

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

AS/ANZ STANDARD 2604-1998

Net Wt. 1.41oz (40g)

PRINCIPAL DISPLAY PANEL

SPF 30+

very water / sweat resistant

broad spectrum

UVA/UVB protection

Proven in extreme new zealand conditions

GolfersSkin "face stick" sunscreen

hands free

Net Wt. 1.41 oz (40g)

aminobenzoic acid (PABA)-free

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOLFERSSKIN FACE SUNSCREEN 
octocrylene, titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75916-3024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.3 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	14.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
AVOCADO OIL (UNII: 6VNO72PFC1)
YELLOW WAX (UNII: 2ZA36H0S2V)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CANDELILLA WAX (UNII: WL0328HX19)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE (UNII: NMQ347994Z)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISOHEXADECANE (UNII: 918X1OUF1E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOSTEARIC ACID (UNII: X33R8U0062)
LANOLIN (UNII: 7EV65EAW6H)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75916-3024-1	1 in 1 BOX
1		40 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)