TAHITIAN NONI SUNSCREEN - avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion 
Wasatch Product Development

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

Avobenzone      2.0%

Homosalate      6.5%

Octinoxate        7.0%

Octisalate         5.0%

Oxybenzone      3.0%

Warnings:

-For external use only

-When using this product keep out of eyes. If contact occurs, rinse thoroughly with water

-Stop use 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.

Use: helps prevent sunburn

Directions:

-apply liberally before sun exposure

-As a doctor before using on children 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 guineesis (palm) oil, butyrospermum parkii (shea butter), vitis vinifera (grape) seed extract, cocous nucifera Oil, gardenia tahitensis (tiare) flower, ascorbyl palmitate, retinyl palmitate, carbomber, potassium sorbate, disodium EDTA, sodium hydroxide, phenoxyethanol, 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
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44717-536
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:44717-536-021 in 1 BOX
1NDC:44717-536-01200 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/28/2010
Labeler - Wasatch Product Development (962452533)
Registrant - Morinda Holdings, Inc. (957926140)
Establishment
NameAddressID/FEIBusiness Operations
Wasatch Product Development962452533manufacture

Revised: 3/2011
Document Id: 1ef931a4-35c1-4f41-a2c1-08c5b835a8fe
Set id: c3f57888-2373-47b1-8c13-ab55a620f9ba
Version: 3
Effective Time: 20110309
 
Wasatch Product Development