TAHITIAN NONI SUNSCREEN SPF 30- avobenzone, homosalate, octinoxate, octisalate, oxybenzone 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.

----------

Sunscreen Lotion SPF 30

Active Ingredients           purpose

Avobenzone 2%            Sunscreen

Homosalate 6.5%         Sunscreen

Octinoxate 7%              Sunscreen  

Octisalate 5%                Sunscreen

Oxybenzone 3%            Sunscreen

Use   helps prevent sunburn

Keep out of reach of children

Stop use and ask a doctor if

-rash or irritation develops and lasts

Warnings

For External Use only

When using this product
Keep out of eyes. If contact occurs, rinse thoroughly with water
.
If swallowed, get medical help or contact a poison control center right away.



Directions:
Apply liberally before sun exposure
Reapply as needed or after towel drying, swimming, or sweating
Ask a doctor before using on children under 6 months of age


Inactive Ingredients: Water (Aqua), Morinda citrifolia (Noni) fruit juice, Glyceryl Stearate SE, C12-15 Alkyl Benzoate, Glycerin, Cetearyl Alcohol, Dimethicone, Ceteareth-20, Morinda citrifolia (Noni) Seed Oil, Prunus Amygdalus dulcis (sweet almond) Oil, Elaeis guinesssis (palm) Oil, Butyrospermum parkii (Shea Butter), Vitis vinifera (grape) seed extract, cocos nucifera oil, Gardenia tahitensis (Tiare) flower, Ascorbyl palmitate, retinyl palmitate Carbomer,potassium sorbate, disodium EDTA, Sodium Hydroxide, phenoxy ethanol, caprylyl glycol, tocopheryl acetate, Fragrance (parfum).





image of back label


Tahitian Noni

Sunscreen Lotion
SPF 30

200 ml 6.76 fl.oz.




image of front label

TAHITIAN NONI  SUNSCREEN SPF 30
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14743-536
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6.5 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.0 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MORINDA CITRIFOLIA SEED OIL (UNII: 84J6H9QZUA)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14743-536-021 in 1 BOX
1NDC:14743-536-01200 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/28/2010
Labeler - Tahitian Noni International (609927905)
Registrant - Wasatch Product Development (962452533)
Establishment
NameAddressID/FEIBusiness Operations
Wasatch Product Development962452533manufacture

Revised: 1/2012
Document Id: 685c76f8-dc8c-4e84-9638-fbd1f81ea7f5
Set id: fff721da-5159-4ff2-b683-50d2889b2c61
Version: 4
Effective Time: 20120130
 
Tahitian Noni International