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Natures Gate

Levlad, LLC

Nature's Gate aqua block SPF 50


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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, Cetyl Dimethicone, Polyglyceryl-4 Isostearate, Glycerin, Jojoba Esters, Copernicia Cerifera (Carnauba) Wax, Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Magnesium Sulfate, Neopentyl Glycol Diisostearate, Sodium Chloride, Triethoxycaprylylsilane, Caprylyl Glycol, Caprylhydroxamic Acid.

Distributed by Nature's Gate • Chatsworth, CA 91311

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

Nature's Gate ®

aqua
block SPF 50

very water resistant
sunscreen | lotion

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

4 FL OZ / 118 mL

Natures Gate

Natures Gate

OCTINOXATE, OCTISALATE, OCTOCRYLENE, and ZINC OXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61380-277
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 75 mg
OCTISALATE OCTISALATE 50 mg
OCTOCRYLENE Octocrylene 70 mg
Zinc Oxide Zinc oxide 69 mg

Inactive Ingredients

Ingredient Name Strength
water
NEOPENTYL GLYCOL DIETHYLHEXANOATE
POLYGLYCERYL-4 ISOSTEARATE
GLYCERIN
carnauba wax
CHAMOMILE
ECHINACEA ANGUSTIFOLIA
ROSEMARY
.ALPHA.-TOCOPHEROL ACETATE, D-
SHEA BUTTER
MAGNESIUM SULFATE, UNSPECIFIED
NEOPENTYL GLYCOL DIISOSTEARATE
SODIUM CHLORIDE
TRIETHOXYCAPRYLYLSILANE
CAPRYLYL GLYCOL
CAPRYLHYDROXAMIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61380-277-27 118 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-03-04


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