Tahitian Noni Sunscreen

Dosage form: lotion
Ingredients: AVOBENZONE 2.0mL in 100mL, HOMOSALATE 6.5mL in 100mL, OCTINOXATE 7.0mL in 100mL, OCTISALATE 5.0mL in 100mL, OXYBENZONE 3.0mL in 100mL
Labeler: Wasatch Product Development
NDC Code: 44717-536

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).

Tahitian Noni

Sunscreen Lotion SPF 30

200 mL/ 6.76 fl. oz.

TAHITIAN NONI  SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44717-536
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2.0 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE6.5 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.0 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5.0 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE3.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MORINDA CITRIFOLIA FRUIT 
GLYCERYL MONOSTEARATE 
ALKYL (C12-15) BENZOATE 
GLYCERIN 
CETOSTEARYL ALCOHOL 
DIMETHICONE 
MORINDA CITRIFOLIA SEED OIL 
VITIS VINIFERA SEED 
SHEA BUTTER 
COCONUT OIL 
GARDENIA TAITENSIS FLOWER 
ASCORBYL PALMITATE 
VITAMIN A PALMITATE 
POTASSIUM SORBATE 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
Packaging
#Item CodePackage Description
1NDC:44717-536-021 BOTTLE (BOTTLE) 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/FEIOperations
Wasatch Product Development962452533manufacture

Revised: 03/2011
 
Wasatch Product Development

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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