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Natures Gate

Levlad LLC

Nature's Gate mineral kid'sblock SPF20


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Natures Gate

TITANIUM DIOXIDE and ZINC OXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61380-259
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 80 mg
Zinc Oxide Zinc oxide 20 mg

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61380-259-27 118 in 1 TUBE
2 NDC:61380-259-24 7 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-03-23


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