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Name:Natures Gate Mineral Kids Block Spf 20
Manufacturer:Levlad Llc
Category:Over-the-counter (OTC) Marketed Drugs


Nature's Gate mineral kid'sblock SPF20

NATURES GATE  MINERAL KIDS BLOCK SPF 20 - titanium dioxide 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
mineral
kid'sblock
SPF20

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

Titanium Dioxide 8.0%, Zinc Oxide 2.0%

INACTIVE INGREDIENTS

Water, Caprylic/capric Triglyceride, Diisopropyl Adipate, Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, Polysorbate 80, Propylheptyl Caprylate, Stearic Acid, Cetearyl Wheat Straw Glycosides, Cetearyl Alcohol, Glyceryl Stearate, Stearyl Alcohol, Prunus Armeniaca (Apricot) Kernel Oil, Aloe Barbadensis Leaf Juice, Euterpe Oleracea (Acai) Fruit Extract, Coffea Arabica (Coffee) Seed Extract, Chamomilla Recutita (Matricaria) Flower Extract, Calendula Officinalis Flower Extract, Althaea Officinalis (Marshmallow) Root Extract, Hydrastis Canadensis (Golden Seal) Extract, Viola Tricolor (Pansy) Extract, Butyrospermum Parkii (Shea) Butter, Bisabolol, Allantoin, Dimethicone, Dehydroxanthan Gum, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Glyceryl Undecylenate.

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

Nature's Gate

mineral
kid's
block
SPF20

kid-friendly

physical |sunscreen

with calendula extract
UVA/UVB protection
fragrance-free
paraben-free

4 FL OZ / 118 mL

Principal Display Panel - 118 mL Tube Label

NATURES GATE   MINERAL KIDS BLOCK SPF 20
titanium dioxide and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61380-259
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 80 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
MEDIUM-CHAIN TRIGLYCERIDES  
DIISOPROPYL ADIPATE  
SAFFLOWER OIL  
GLYCERIN  
POLYSORBATE 80  
PROPYLHEPTYL CAPRYLATE  
STEARIC ACID  
CETYL GLUCOSIDE  
STEARYL GLUCOSIDE  
CETOSTEARYL ALCOHOL  
GLYCERYL MONOSTEARATE  
STEARYL ALCOHOL  
APRICOT SEED OIL  
ALOE VERA LEAF  
ACAI  
ARABICA COFFEE BEAN  
CHAMOMILE  
CALENDULA OFFICINALIS FLOWER  
ALTHAEA OFFICINALIS ROOT  
GOLDENSEAL  
VIOLA TRICOLOR  
SHEA BUTTER  
LEVOMENOL  
ALLANTOIN  
DIMETHICONE 350  
XANTHAN GUM  
TRIETHOXYCAPRYLYLSILANE  
PHENOXYETHANOL  
ETHYLHEXYLGLYCERIN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61380-259-27 118 mL in 1 TUBE None
2 NDC:61380-259-24 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 03/23/2010

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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