Label: NATRIA BRIGHTENING SPF 15- ethylhexl methoxycinnamate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 44717-538-01, 44717-538-02 - 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 11, 2011
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ACTIVE INGREDIENT
Active Ingredients
Ethylhexyl Methoxycinnamate 7.5%
Zinc Oxide 4%provides instant hydration and long- lasting defense against UV rays to keep skin clear from discoloration
Avoid contact with eyes. Rinse with water if eye contact occurs. Discontinue use and contact a doctor if rash or irritation develops and persists.
Ingredients: Water (Aqua), Cyclopentasiloxane, Cetearyl Glucoside, Isopentyldiol, C12-15 Alkyl Benzoate, Dimethicone, Glycyrrhiza Glabra (Licorice) Root Extract, Morus Alba (Mulberry) Root Extract, Plankton Extract, Farnesyl Acetate, Farnesol, Glycine Soja (Soybean) Lipids, Retinyl Palmitate (Vitamin A), Panthenyl Triacetate (Vitamin B), Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Aloe Barbadensis, Camellia Oleifera (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Ulva Lactuca (Sea Lettuce) Extract, Vitis Vinifera (Grape) Seed Extract, Fragrance (Essential Oils), Squalane, Zea Mays (Corn) Oil, Algae Extract, Artemisia Princeps Leaf Extract, Sodium PCA, Ergothioneine, Caprylic/Capric Triglyceride, Behenyl Alcohol, Magnesium Aluminu Silicate, Butylene Glycol, Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Glycerin, Phenoxyethanol, Chlorphenesin, Methylparaben, Benzoic Acid.
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INGREDIENTS AND APPEARANCE
NATRIA BRIGHTENING SPF 15
ethylhexl methoxycinnamate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44717-538 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOPENTYLDIOL (UNII: 19NOL5474Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) SQUALENE (UNII: 7QWM220FJH) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44717-538-02 1 in 1 BOX 1 NDC:44717-538-01 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/19/2010 Labeler - Wasatch Product Development (962452533) Registrant - Nature's Sunshine (081832388) Establishment Name Address ID/FEI Business Operations Wasatch Product Development 962452533 manufacture