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Name:Natures Gate Sport Block Spf 50
Manufacturer:Levlad Llc
Category:Over-the-counter (OTC) Marketed Drugs


Nature's Gate sportblock SPF 50

NATURES GATE  SPORT BLOCK SPF 50 - octinoxate, octisalate, octocrylene and zinc oxide lotion 
Levlad LLC

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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Nature's Gate
sport
block SPF 50

DIRECTIONS

Apply liberally and evenly 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months of age: ask a doctor.

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 or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

ACTIVE INGREDIENTS

Octinoxate 7.5%, Octisalate 5%, Octocrylene 7%, Zinc Oxide 6.9%

INACTIVE INGREDIENTS

Water, Polyglyceryl-2 Dipolyhydroxystearate, Neopentyl Glycol Diethylhexanoate, Polyglyceryl-4 Isostearate, Cetyl Dimethicone, Dicaprylyl Ether, Glycerin, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Cucumis Sativus (Cucumber) Fruit Extract, Lavandula Angustifolia (Lavender) Flower Extract, Hippophae Rhamnoides Extract, Tocopheryl Acetate, Magnesium Sulfate, Neopentyl Glycol Diisostearate, Sodium Chloride, Triethoxycaprylylsilane, Caprylyl Glycol, Caprylhydroxamic Acid.

Distributed by Nature's Gate
Chatsworth, CA 91311

www.natures-gate.com

PRINCIPAL DISPLAY PANEL 118 mL Tube Label

Nature's Gate

sport
block SPF 50

sweat resistant dry finish

sunscreen | lotion
with cucumber extract

UVA/UVB protection
fragrance-free
paraben-free

4 FL OZ / 118 mL

Principal Display Panel

NATURES GATE   SPORT BLOCK SPF 50
octinoxate, octisalate, octocrylene, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61380-278
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 70 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 69 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
NEOPENTYL GLYCOL DIETHYLHEXANOATE  
POLYGLYCERYL-4 ISOSTEARATE  
DICAPRYLYL ETHER  
GLYCERIN  
MEDIUM-CHAIN TRIGLYCERIDES  
ALOE VERA LEAF  
CUCUMBER  
LAVANDULA ANGUSTIFOLIA FLOWER  
HIPPOPHAE RHAMNOIDES FRUIT  
.ALPHA.-TOCOPHEROL ACETATE, D-  
MAGNESIUM SULFATE, UNSPECIFIED  
NEOPENTYL GLYCOL DISOSTEARATE  
SODIUM CHLORIDE  
TRIETHOXYCAPRYLYLSILANE  
CAPRYLYL GLYCOL  
CAPRYLHYDROXAMIC ACID  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61380-278-27 118 mL in 1 TUBE None
2 NDC:61380-278-24 7 mL in 1 PACKET None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 03/04/2011

Labeler - Levlad LLC (076245109)
Establishment
Name Address ID/FEI Operations
Levlad LLC 076245109 MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 04/2011 Levlad LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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