TEMANA TAHITI NONI BRIGHTENING FACIAL SHIELD SPF50- avobenzone, octinoxate, ensulizole lotion 
Tahitian Noni International

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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Morinda TeMana tahiti NONI Brightening Facial Shield Sunscreen SPF 50

Active Ingredients:

Avobenzone 7.35%

Ensulizole 3.00%

Octinoxate   1.85%

Purpose

  Sunscreen

Uses

Helps prevent sunburn

Warnings

  • Do not stay too lon gin the syn even while usin ga sunscreen product.  Avoid intense midday sun.   OVerexposure to the sun is a serious heath threat.
  • ​For external use only.  Use only as directed.
  • Do not use on damaged or broken skin.

  • When using this product keep out of eyes. Rinse thoroughly with water to remove.

  • ​Discontinue use if irritation occurs, and ask a doctor if rash or irritation develops and lasts.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • After cleansing, apply a generous amount evenly over face 15 minutes before sun exposure to obtain SPF 50+ protection. For facial use only.
  • Repeat regularly for sustained protection.  Applying too little will reduce the level of protection.
  • For use by adults only.

Inactive Ingredients:

Morinda Citrifolia Fruit Juice, Morinda Citrifolia Leaf Juice, Morinda Citrifolia Seed Extract, Bis-Diglyceryl Polyacyladipate-2, Butyrospermum Parkii (Shea ) Butter, Cetyl Alcohol, Cyclopentasiloxane, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-40 Stearate, Pentylene Glycol, Phenoxyethanol, Polyacrylate Crosspolymer-6, Polysorbate 60, Sodium Hydroxide,
Sorbitan Stearate, Squalene, Tetrasodium Glutamate Diacetate, Water

Brightening Shield

TEMANA TAHITI NONI BRIGHTENING FACIAL SHIELD  SPF50
avobenzone, octinoxate, ensulizole lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14743-344
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE7.35 g  in 100 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3.00 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.85 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MORINDA CITRIFOLIA FRUIT JUICE (UNII: 6ULF85Z07J)  
MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5)  
MORINDA CITRIFOLIA SEED (UNII: 7MSU7J1U77)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SQUALANE (UNII: GW89575KF9)  
Tetrasodium glutamate diacetate (UNII: 5EHL50I4MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14743-344-0140 g in 1 TUBE; Type 0: Not a Combination Product12/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/13/201712/08/2020
Labeler - Tahitian Noni International (609927905)

Revised: 12/2020
Document Id: 3967a6d2-5be8-4d23-b131-35386cec3d8d
Set id: c2a6aeec-c417-46e2-bc89-3515e924b498
Version: 5
Effective Time: 20201208
 
Tahitian Noni International