TAHITIAN NONI TEPOEMA ELEMENT SHIELD SPF 20- avobenzone, octinoxate, octisalate lotion 
Tahitian Noni International Inc.

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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Tahitian Noni Element Shield

Active Ingredients:

Avobenzone 2%,  Octinoxate 7.5%, Octisalate 5%.

Other Ingredients:

Micro-Swelling Defense Complex I: [Water(aqua), Morinda citrifolia (Noni) Fruit Juice, Morinda citrifolia(Noni) Leaf Juice,  Morinda Citrifolia (Noni) Leaf Extract], Cetearyl Alcohol, C12-15 Alkyl Benzoate, Dimethicone, Butylene Glycol, Cetearyl Glucoside, Morinda citrifolia (Noni) Seed Oil, Centella asiatica (Hydrocotyl) Extract, Curcuma longa (Turmeric) Root Extract, Glycine soja (Soybean) Seed Sterol, Glycine soya (Soybean) Seed Extract, Macrocystis pyrifera (Kelp) Extract  Monoi Oil [Cocos nucifera Oil, Gardenia tahentensis (Tiare) Flower], Moringa oleifera Seed Oil, Musa sapeintum (Banana) Extract, Pikea robusta (red Algae) Extract, Vanilla tehitensis (Vanilla) Fruit Extract, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol,  Caprylyl Glycol, Xanthan Gum, Panthenol, Potassium Sorbate, Fragrance(Parfum), Disodium EDTA, Ceramide 3. Ethoxydiglycol, Sodium Hyaluronate.

Element Shield

This light lotion disappears into skin yet provides long lasting UVA and UVB protection.

Directions: After moisturizing , apply smoothly over face and neck before sun exposure, contact with harsh elements or pollution and as needed.  This should always be your last step in the regimen.

Warnings: For external use only.  Keep out of eyes.  If contact occurs, rinse with water to remove.  Stop use and ask a doctor if rash or irritation develops.  Keep out of reach of children.

Element Shield

TAHITIAN NONI TEPOEMA ELEMENT SHIELD  SPF 20
avobenzone, octinoxate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14743-085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SOYBEAN (UNII: L7HT8F1ZOD)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TURMERIC (UNII: 856YO1Z64F)  
PANTHENOL (UNII: WV9CM0O67Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
VANILLA (UNII: Q74T35078H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14743-085-021 in 1 CARTON11/01/2005
1NDC:14743-085-0150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/200512/31/2018
Labeler - Tahitian Noni International Inc. (609927905)

Revised: 12/2018
 
Tahitian Noni International Inc.