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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Natures Gate® Aqua SPF 50

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

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

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label
NATURES GATE AQUA SPF 50 
homosalate, octinoxate, octisalate, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61380-156
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 WHOLE (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61380-156-27118 mL in 1 TUBE; Type 0: Not a Combination Product03/08/201704/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/08/201704/16/2020
Labeler - Levlad, LLC (076245109)
Establishment
NameAddressID/FEIBusiness Operations
Levlad, LLC076245109MANUFACTURE(61380-156) , ANALYSIS(61380-156) , LABEL(61380-156) , PACK(61380-156)

Revised: 6/2020
Document Id: 00d09982-6ef1-4d3c-9318-30d1a3ba0137
Set id: b1b02456-aacc-4976-ac54-6d5616e431af
Version: 2
Effective Time: 20200602
 
Levlad, LLC