TAHITIAN NONI SUNSCREEN SPF 30- 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 Tahitian Noni International, Wasatch Product Development. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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).

PRINCIPAL DISPLAY PANEL

Tahitian Noni

Sunscreen Lotion
SPF 30

200 ml 6.76 fl.oz.

INGREDIENTS AND APPEARANCE

TAHITIAN NONI  SUNSCREEN SPF 30
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14743-536
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: 14743-536-02	1 in 1 BOX
1	NDC: 14743-536-01	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 - Tahitian Noni International (609927905)

Registrant - Wasatch Product Development (962452533)

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