TAHITIAN NONI SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Tahitian Noni by

Drug Labeling and Warnings

Tahitian Noni by is a Otc medication manufactured, distributed, or labeled by Wasatch Product Development, Morinda Holdings, Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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).

PRINCIPAL DISPLAY PANEL

Tahitian Noni

Sunscreen Lotion SPF 30

200 mL/ 6.76 fl. oz.

INGREDIENTS AND APPEARANCE

TAHITIAN NONI  SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44717-536
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.5 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.0 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44717-536-02	1 in 1 BOX
1	NDC: 44717-536-01	200 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/28/2010

Labeler - Wasatch Product Development (962452533)

Registrant - Morinda Holdings, Inc. (957926140)

Establishment
Name	Address	ID/FEI	Business Operations
Wasatch Product Development		962452533	manufacture