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Natures Gate Mineral Kids Block SPF 20

Dosage form: lotion
Ingredients: TITANIUM DIOXIDE 80mg in 1mL, ZINC OXIDE 20mg in 1mL
Labeler: Levlad LLC
NDC Code: 61380-259

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.

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

NATURES GATE   MINERAL KIDS BLOCK SPF 20
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61380-259
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE80 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:61380-259-27118 mL in 1 TUBE
2NDC:61380-259-247 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/23/2010
Labeler - Levlad LLC (076245109)
Establishment
NameAddressID/FEIOperations
Levlad LLC076245109MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 04/2011
 
Levlad LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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