Label: TAHITIAN NONI SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 44717-536-01, 44717-536-02 - Packager: Wasatch Product Development
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 9, 2011
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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).
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INGREDIENTS AND APPEARANCE
TAHITIAN NONI SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotionProduct 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
