Tahitian Noni
FDA Label NDC 44717-536

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wasatch Product Development for the product Tahitian Noni (NDC 44717-536). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, warnings, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Avobenzone      2.0%

Homosalate      6.5%

Octinoxate        7.0%

Octisalate         5.0%

Oxybenzone      3.0%

Warnings

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.

Indications & Usage

Use: helps prevent sunburn

Directions:

-apply liberally before sun exposure

-As a doctor before using on children 6 months of age

Inactive Ingredient

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 (Back)

Image Of Back Label (Back)

Package Label.Principal Display Panel

Tahitian Noni

Sunscreen Lotion SPF 30

200 mL/ 6.76 fl. oz.

Image Of Front Label (Front)

Image Of Front Label (Front)

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