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Natures Gate

Levlad, LLC

Nature's Gate Sport SPF 20 Mineral


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Titanium dioxide 8.3%
Zinc oxide 2%

Purpose

Sunscreen

Natures Gate Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

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.

Directions

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.–2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Natures Gate Other information

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

allantoin, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetearyl alcohol, cetearyl wheat straw glycosides, chamomilla recutita (matricaria) flower extract, dehydroxanthan gum, diisopropyl adipate, dimethicone, ethylhexylglycerin, euterpe oleracea (açai) fruit extract, glycerin, glyceryl stearate, glyceryl undecylenate, macrocystis pyrifera extract, mimosa tenuiflora bark extract, phenoxyethanol, polysorbate 80, propylheptyl caprylate, prunus armeniaca (apricot) kernel oil, rosmarinus officinalis (rosemary) leaf extract, silybum marianum (milk thistle) seed extract, stearic acid, stearyl alcohol, triethoxycaprylylsilane, viola tricolor (wild pansy) extract, VP/eicosene copolymer, water.

Questions or comments?

1 (800) 327-2012 Monday – Friday 8 a.m. – 5 p.m. PST

Distributed by Nature's Gate
Chatsworth, CA 91311

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

Nature's Gate ®

sport
broad spectrum
SPF 20

dry finish

mineral
sunscreen |

lotion

water resistant
(80 minutes)

fragrance-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:61380-311
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 83 mg
Zinc Oxide Zinc oxide 20 mg

Inactive Ingredients

Ingredient Name Strength
ALLANTOIN
Aloe Vera Leaf
SHEA BUTTER
MEDIUM-CHAIN TRIGLYCERIDES
SAFFLOWER OIL
CETOSTEARYL ALCOHOL
CETYL GLUCOSIDE
STEARYL GLUCOSIDE
CHAMOMILE
XANTHAN GUM
DIISOPROPYL ADIPATE
DIMETHICONE
ETHYLHEXYLGLYCERIN
ACAI
GLYCERIN
GLYCERYL 1-STEARATE
MACROCYSTIS PYRIFERA
MIMOSA TENUIFLORA BARK
PHENOXYETHANOL
polysorbate 80
propylheptyl caprylate
Apricot Kernel Oil
ROSEMARY
SILYBUM MARIANUM SEED
STEARIC ACID
stearyl alcohol
TRIETHOXYCAPRYLYLSILANE
VIOLA TRICOLOR
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61380-311-27 118 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-02-14


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