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Name:Natures Gateface Block Spf 25 Fragrance-free
Manufacturer:Levlad Llc
Category:Over-the-counter (OTC) Marketed Drugs


Natures Gate face block SPF 25

NATURES GATE FACE BLOCK SPF 25 FRAGRANCE-FREE - 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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Natures Gate
face
block SPF 25

DIRECTIONS

Apply liberally and evenly 30 minutes before sun exposure. Reapply every 2 hours 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 occurs. 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 6%, Zinc Oxide 4%

INGREDIENTS

Water, Cocoglycerides, Ethylhexyl Palmitate, Glyceryl Stearate SE, Cetyl Phosphate, Glycerin, Cetearyl Alcohol, Sorbitan Stearate, Cetyl Dimethicone, Allantoin, Panthenol, Cocos Nucifera (Coconut) Oil, Rosa Canina (Rosehip) Seed Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Psidium Guajava (Guava) Fruit Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Echinacea Angustifolia (Coneflower) Leaf Extract, Prunus Amygdalus Dulcis (Sweet Almond) Fruit Extract, Solanum Lycopersicum (Tomato) Fruit/leaf/stem Extract, Magnesium Ascorbyl Phosphate, Tocopheryl Acetate, Sodium Hyaluronate, Dimethicone, Xanthan Gum, Caprylyl Glycol, Triethoxycaprylylsilane, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Glyceryl Undecylenate.

Distributed by Nature's Gate
Chatsworth, CA 91311
Made in USA
www.natures-gate.com

1-800-327-2012

PRINCIPAL DISPLAY PANEL - 4 FL OZ Tube

Nature's Gate

face
block SPF 25

fragrance-free

sunscreen lotion

with Almond Extract

paraben-free

UVA/UVB protection

4 FL OZ / 118 mL

Principal Display Panel

NATURES GATE  FACE BLOCK SPF 25 FRAGRANCE-FREE
octinoxate, octisalate, octocrylene, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61380-264
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 60 mg  in 1 mL
Zinc Oxide (Zinc) Zinc Oxide 40 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61380-264-11 118 mL in 1 TUBE None
2 NDC:61380-264-24 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 04/12/2010

Labeler - Levlad LLC (076245109)

Revised: 05/2010 Levlad LLC



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


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