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

TeMana Tahiti Noni Brightening Facial Shield by

Drug Labeling and Warnings

TeMana Tahiti Noni Brightening Facial Shield by is a Otc medication manufactured, distributed, or labeled by Tahitian Noni International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TEMANA TAHITI NONI BRIGHTENING FACIAL SHIELD  SPF50
avobenzone, octinoxate, ensulizole lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14743-344
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	7.35 g  in 100 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	3.00 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.85 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14743-344-01	40 g in 1 TUBE; Type 0: Not a Combination Product	12/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/13/2017

Labeler - Tahitian Noni International (609927905)