GOLFERS SKIN SUNSCREEN - octinoxate, oxybenzone, titanium dioxide and 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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Active Ingredients

Octinoxate 7.5%

Oxybenzone 3.45%

Titanium Dioxide 1%

Zinc Oxide 1.95%

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

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

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

Golferssskin 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.golfersskin.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

Golfersskin Sunscreen

Proven in Extreme New Zealand conditions

manuka honey UMF 18

CONTAINS NO NANOPARTICLES - AMINOBENZOIC ACID (PABA)-FREE

Representative Product Labeling

Sunscreen

Golfers Skin 2000ml (75916-4020-5)

GolferSkin2000FrontPanel

GolferSkin2000

GOLFERS SKIN SUNSCREEN
octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75916-4020
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (OCTINOXATE)	OCTINOXATE	7.5 mL in 100 mL
OXYBENZONE (OXYBENZONE)	OXYBENZONE	3.45 mL in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	1 mL in 100 mL
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	1.95 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF
MEDIUM-CHAIN TRIGLYCERIDES
CETOSTEARYL ALCOHOL
CYCLOMETHICONE
WATER
GLYCERYL MONOSTEARATE
PHENOXYETHANOL
POLYSORBATE 60
VITAMIN A PALMITATE
SORBITAN MONOSTEARATE
ALPHA-TOCOPHEROL ACETATE
HONEY

Packaging
#	Item Code	Package Description
1	NDC:75916-4020-4	125 mL in 1 TUBE
2	NDC:75916-4020-1	1 in 1 BOX
2		40 mL in 1 TUBE
3	NDC:75916-4020-3	1000 mL in 1 BOTTLE
4	NDC:75916-4020-5	2000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/31/2011

Labeler - Skin Alive, Ltd. (593384746)

Revised: 03/2012

Document Id: 66b58a90-8fbe-42e8-8d03-4999c4450642

Set id: d1472c0d-1a60-4df5-b523-24fccf3ba7eb

Version: 3

Effective Time: 20120307

Skin Alive, Ltd.