Natures Gate description, usages, side effects, indications, overdosage, supplying and lots more!

Natures Gate

Levlad LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Nature's Gate kids SPF 50

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredient Purpose
Octinoxate 7.5%
Octisalate 5% Sunscreen
Octocrylene 7%
Zinc oxide 6.9%

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 40 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

Other information

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

Inactive ingredients

aloe barbadensis leaf juice, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, caprylyl glycol, cetyl dimethicone, chamomilla recutita (matricaria) flower extract, glycerin, isopropyl palmitate, magnesium sulfate, neopentyl glycol diethylhexanoate, neopentyl glycol diisostearate, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-4 isostearate, rosmarinus officinalis (rosemary) leaf extract, sodium chloride, tocopheryl acetate, triethoxycaprylylsilane, 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®

kids
broad spectrum
SPF 50

pediatrician tested

sunscreen | lotion

water resistant
(40 minutes)

fragrance-free

4 FL OZ / 118 mL

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

Natures Gate

octinoxate, octisalate, octocrylene, and zinc oxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61380-314
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
Aloe Vera Leaf
CALENDULA OFFICINALIS FLOWER
CAPRYLHYDROXAMIC ACID
MEDIUM-CHAIN TRIGLYCERIDES
CAPRYLYL GLYCOL
CHAMOMILE
GLYCERIN
ISOPROPYL PALMITATE
MAGNESIUM SULFATE ANHYDROUS
NEOPENTYL GLYCOL DIETHYLHEXANOATE
NEOPENTYL GLYCOL DIISOSTEARATE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
POLYGLYCERYL-4 ISOSTEARATE
ROSEMARY
SODIUM CHLORIDE
.ALPHA.-TOCOPHEROL ACETATE
TRIETHOXYCAPRYLYLSILANE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61380-314-27 118 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-06-15


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