GOLFERS SKIN BROAD SPECTRUM SPF 30 PLUS SUNSCREEN - octinoxate, oxybenzone, titanium dioxide, 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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Golfers Skin Broad Spectrum SPF 30+ Sunscreen

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


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

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

GolfersSkin

GOLFERS SKIN BROAD SPECTRUM SPF 30 PLUS SUNSCREEN  
octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75916-4020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE34.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75916-4020-4125 mL in 1 TUBE
2NDC:75916-4020-11 in 1 BOX
240 mL in 1 TUBE
3NDC:75916-4020-31000 mL in 1 BOTTLE
4NDC:75916-4020-52000 mL in 1 BOTTLE
5NDC:75916-4020-25 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/31/2011
Labeler - Skin Alive, Ltd. (593384746)
Registrant - Skin Alive, Ltd. (593384746)

Revised: 1/2015
Document Id: 430fa1b2-bb36-4cc9-bc10-08d4e910e4ce
Set id: d1472c0d-1a60-4df5-b523-24fccf3ba7eb
Version: 6
Effective Time: 20150113
 
Skin Alive, Ltd.