NATURES GATE AQUA SPF 50- homosalate, octinoxate, octisalate, and zinc oxide lotion

Natures Gate Aqua SPF 50 by

Drug Labeling and Warnings

Natures Gate Aqua SPF 50 by is a Otc medication manufactured, distributed, or labeled by Levlad, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Homosalate 10%
Octinoxate 7.5%
Octisalate 5%
Zinc oxide 10%

Purpose

Sunscreen

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

Other information

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

Inactive ingredients

benzyl alcohol, butyrospermum parkii (shea) butter, caprylhydroxamic acid, chamomilla recutita (matricaria) flower extract, coco-caprylate, copernicia cerifera (carnauba) wax, echinacea angustifolia leaf extract, glycerin, jojoba esters, magnesium sulfate, phytic acid, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-4 isostearate, rosmarinus officinalis (rosemary) leaf extract, sodium chloride, tocopherol, tocopheryl acetate, water.

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Distributed by Nature's Gate
www.naturesgate.com

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

NATURE'S
GATE®

AQUA
Vegan Sunscreen

Broad Spectrum
SPF 50

Water Resistant
(80 minutes)

4 FL OZ / 118 mL

INGREDIENTS AND APPEARANCE

NATURES GATE AQUA SPF 50 
homosalate, octinoxate, octisalate, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61380-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CHAMOMILE (UNII: FGL3685T2X)
COCO-CAPRYLATE (UNII: 4828G836N6)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
GLYCERIN (UNII: PDC6A3C0OX)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
FYTIC ACID (UNII: 7IGF0S7R8I)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ROSEMARY (UNII: IJ67X351P9)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61380-156-27	118 mL in 1 TUBE; Type 0: Not a Combination Product	03/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/08/2017

Labeler - Levlad, LLC (076245109)

Establishment
Name	Address	ID/FEI	Business Operations
Levlad, LLC		076245109	MANUFACTURE(61380-156) , ANALYSIS(61380-156) , LABEL(61380-156) , PACK(61380-156)