NATURES GATE  SPORT SPF 20 MINERAL- titanium dioxide 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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Nature's Gate®
Sport SPF 20 Mineral

Drug Facts

Active ingredient

Titanium dioxide 8.3%
Zinc oxide 2%

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

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®

Mineral
Sunscreen

SPORT

Vegan Sunscreen

Broad Spectrum
SPF 20

Water Resistant
(80 minutes)

4 FL OZ / 118 mL

Principal Display Panel - 118 mL Tube Label
NATURES GATE   SPORT SPF 20 MINERAL
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61380-311
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE83 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL GLUCOSIDE (UNII: 0O529Z601A)  
STEARYL GLUCOSIDE (UNII: 880752Z9EG)  
CHAMOMILE (UNII: FGL3685T2X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ACAI (UNII: 46AM2VJ0AW)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
ROSEMARY (UNII: IJ67X351P9)  
MILK THISTLE (UNII: U946SH95EE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
VIOLA TRICOLOR WHOLE (UNII: 9Q24RAI43V)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61380-311-27118 mL in 1 TUBE; Type 0: Not a Combination Product02/14/201302/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/14/201302/16/2020
Labeler - Levlad, LLC (076245109)
Establishment
NameAddressID/FEIBusiness Operations
Levlad, LLC076245109MANUFACTURE(61380-311) , ANALYSIS(61380-311) , LABEL(61380-311) , PACK(61380-311)

Revised: 6/2020
Document Id: d9128da6-b194-40c4-9f69-b2f09f5d661a
Set id: 39b048f3-47d6-4f2e-b838-1cab666e6fbf
Version: 3
Effective Time: 20200602
 
Levlad, LLC