GOLFERS SKIN BROAD SPECTRUM SPF 30 PLUS SUNSCREEN- octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

Golfers Skin Broad Spectrum SPF 30 Plus Sunscreen by

Drug Labeling and Warnings

Golfers Skin Broad Spectrum SPF 30 Plus Sunscreen by is a Otc medication manufactured, distributed, or labeled by Skin Alive, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Golfers Skin Broad Spectrum SPF 30+ Sunscreen

Active Ingredients

Octinoxate 7.5%

Oxybenzone 3.45%

Titanium Dioxide 1%

Zinc Oxide 1.95%

Purpose

Sunscreen

Uses

• Helps prevents sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  

Warnings

For external use only

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously 15 mins before sun exposure.
Reapply:

    * After 40 minutes of swimming  or sweating.
    * Immediately after towel drying
    * At least every 2 hours

Sun Protections Measure. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use and sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

    * Limit time in the sun, especially from 10am-2pm
    * Wear long-sleeve shirts, pants, hats and sunglasses
    * Children under 6 months: Ask a Doctor

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

GOLFERS SKIN BROAD SPECTRUM SPF 30 PLUS 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	34.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
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
5	NDC: 75916-4020-2	5 mL in 1 PACKET

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)

Registrant - Skin Alive, Ltd. (593384746)